The magnitude of chronic diabetes complications and its associated factors among diabetic patients attending the general hospitals in Tigray region, Northern Ethiopia

Kalayou K Berhe; Lilian T Mselle; Haftu B Gebru

doi:10.1371/journal.pone.0290240

. 2023 Aug 25;18(8):e0290240. doi: 10.1371/journal.pone.0290240

The magnitude of chronic diabetes complications and its associated factors among diabetic patients attending the general hospitals in Tigray region, Northern Ethiopia

Kalayou K Berhe ^1,^*, Lilian T Mselle ², Haftu B Gebru ¹

Editor: Manal S Fawzy³

PMCID: PMC10456170 PMID: 37624794

Abstract

Background

Diabetes is a severe challenge to global public health since it is a leading cause of morbidity, mortality, and rising healthcare costs. 3.0 million Ethiopians, or 4.7% of the population, had diabetes in 2021. Studies on the chronic complications of diabetes in Ethiopia have not been conducted in lower-level healthcare facilities, so the findings from tertiary hospitals do not accurately reflect the issues with chronic diabetes in general hospitals. In addition, there is a lack of information and little research on the complications of chronic diabetes in Ethiopia. The objective of this study was to assess the degree of chronic diabetes complications and associated factors among diabetic patients presenting to general hospitals in the Tigray area in northern Ethiopia.

Methods

As part of a multi-centre cross-sectional study, 1,158 type 2 diabetes (T2D) patients from 10 general hospitals in the Tigray region were randomly chosen. An interviewer-administered questionnaire, a record review, and an SPSS version 20 analysis were used to collect the data. All continuous data were presented as mean standard deviation (SD), while categorical data were identified by frequencies. Using a multivariable logistic regression model, the factors associated with chronic diabetes complications among T2D diabetic patients were found, and linked factors were declared at p 0.05.

Results

Fifty-four of people with diabetes have chronic problems. Hypertension (27%) eye illness, renal disease (19.1%), and hypertension (27%) eye disease were the most common long-term effects of diabetes. Patients with chronic diabetes complications were more likely to be older than 60, taking insulin and an OHGA (Oral Hyperglycemic Agent) (AOR = 3.00; 95% CI 1.73, 5.26), having diabetes for more than five years, taking more than four tablets per day (AOR = 1.63; 95% CI 1.23,2.15), and having high systolic and diastolic blood pressure. Patients with government employment (AOR = 0.48; 95% CI 0.26, 0.90), antiplatelet drug use (AOR = 0.29; 95% CI 0.16, 0.52), and medication for treating dyslipidemia (AOR = 0.54; 95% CI 0.35, 0.84), all had a decreased chance of developing a chronic diabetes problem.

Conclusion

At least one chronic diabetic complication was present in more than half of the patients in this study. Chronic diabetes problems were related to patients’ characteristics like age, occupation, diabetes treatment plan, anti-platelet, anti-dyslipidemia medicine, duration of diabetes, high Systolic BP, high Diastolic BP, and pill burden. To avoid complications from occurring, diabetes care professionals and stakeholders must collaborate to establish appropriate methods, especially for individuals who are more likely to experience diabetic complications.

Background

Hyperglycemia is a metabolic condition associated with diabetes mellitus [1]. There are two basic forms of diabetes: Type 1 diabetes and Type 2 diabetes. Type 1 diabetes mainly affects youngsters and is defined by an insulin shortage that necessitates daily insulin injections [2]. The most prevalent form of diabetes with insulin resistance and a relative insulin deficit is type 2 [3]. There are now more cases of diabetes than ever before due to population growth, age, urbanization, obesity, and inactivity [4]. The prevalence of diabetes was found to be 10.5% (537 million people) worldwide, 4.5% (24 million people) in Africa, and 4.7% (3 million people) in Ethiopia, according to an IDF (International Diabetes Federation) atlas report from 2021 [5].

Diabetes impacts people’s functional skills and quality of life, leading to severe morbidity and premature mortality, and is one of the top public health concerns in the globe [6]. It negatively affects socioeconomic development and public health globally [7]. [8] Diabetes accounts for more than 80% of all early fatalities from non-communicable diseases (NCDs), along with cardiovascular disease, cancer, and respiratory illnesses [8]. In addition, patients with diabetes have a two to three times higher risk of dying from any cause, including cancer, cardiovascular disease, stroke, chronic renal disease, and liver disease [9–11]. Due to insufficient monitoring and skewed or incorrect laboratory data, patients are more likely to have limited compliance with therapies in outpatient settings [12]. Diabetic individuals with poorly controlled hyperglycemia can develop macrovascular diseases such as peripheral artery disease, cardiovascular disease, and cerebrovascular disease as well as microvascular consequences like retinopathy, nephropathy, and neuropathy [13,14].

For instance, studies on the prevalence of chronic diabetic complications revealed that 96% of patients had hypertension, 46% had peripheral neuropathy, 30% had neuropathy, and 7% had neuropathy encountered impotence [15] and the main reason for admission was diabetic foot ulcer (39%) and cardiovascular disease (21%) [16]. Diabetic retinopathy is a prominent cause of blindness, of which 2.6% is attributed to diabetes [17]. In addition, glaucoma, cataract, and other disorder of the eye occur earlier and more frequently in people with diabetes [18]. Similarly, there is a remarkable prevalence of both acute and chronic complications in diabetic cases in Ethiopia [19].

Information on the prevalence of diabetes-related complications is essential to change diabetes management policies and practices to effectively control the disease. However, studies focusing on such topics are rare in Ethiopia [15,20,21] and no studies have been conducted in the study area. In Ethiopia, diabetes-related studies mainly focused on glycemic control, dyslipidemia, self-care management, diabetes prevalence and diabetes complications in hospitalized/high-risk patients [22–26].

Although very few studies on chronic diabetes complications have been conducted in different parts of the country, there has not been a recent comprehensive study of outpatients in general hospitals. On the other hand, because those studies were conducted in tertiary hospitals, they were unable to provide a precise picture of diabetes complications at a lower level, such as in general hospitals. In addition, those studies were carried out among high-risk individuals, the study population of type 1 and 2 diabetes, assessing only acute complications, microvascular or macrovascular complications, and in some studies data were collected through document review only. Furthermore, it is essential to investigate diabetes complications and their contributing factors regularly to pot evolving patterns and formulate diabetes management strategies. Therefore, this study aimed to identify chronic complications related to diabetes and associated factors in general hospitals in the Tigray region of Northern Ethiopia.

Method and materials

Study design, setting and period

A multi-centre cross-sectional study was conducted in the Tigray region from September 2019 to January 2020. Tigray is one of the ten regional states of Ethiopia. The Ethiopian health care system is organized into three-tier: primary, secondary and tertiary levels of care. The primary level of care is provided at a primary hospital, health centre and health post. The Primary Health care Unit (PHCU) is composed of a health centre (HC) and five satellite health posts (HP). These facilities provide service to approximately 25,000 people. A primary hospital provides inpatient and ambulatory service to an average of 100,000 Population and has an inpatient capacity of 25–50 beds. A general hospital provides inpatient and ambulatory services to an average of 1,000,000 people. A tertiary hospital serves an average of five million people. It serves as a referral to the general hospital [27].

In 2019/2020, in the Tigray region, there were 2 referral hospitals, 14 general hospitals, 24 primary hospitals, 230 health centres and 741 health posts. There were more than 310 ambulances and a well-established referral system. There were over 750 private health facilities in the private sector, ranging from drug vendors and clinics to general and specialized hospitals. There were more than 25,000 health workforce ranging from health extension workers to specialists and sub-specialists [28]. This study was done in ten selected public general hospitals namely Alamata, Lemlem Carl, Mekelle, Adigrat, kids Mariam, Adwa, Abiyi Adi, Shule Shire, Sheraro Mayani and Kahsay Abera (Humera). These general hospitals provide basic health services for patients with different diseases including diabetes mellitus. About 4,154 patients with type 2 diabetes received health services at these public general hospitals in 2018/19 [29].

Population

All type 2 diabetic (T2D) patients admitted to the study hospitals and those who attended diabetic clinics during the data collection period participated in the study. To be involved in the study participants had to be adult.

Eligibility

Inclusion criteria

All adult patients aged more than 18 years who were diagnosed to have T2D and had follow-up visits in the study hospitals for ≥1 year. The study did not include patients.

Exclusion criteria

All Patients who were pregnant and critically ill.

Sample Size determination

The sample size (n) was estimated using a single population proportion formula proposed by Cochran [30] with an assumption of 95% confidence interval (z = 1.96), a margin of error of 0.03 and the proportion of chronic diabetes complication among T2D patients from a study in Northwestern Ethiopia which was 53.5% (P = 0.535) [21]. The initial sample size was 1,061 which was obtained using the following formula ni = (Z1-α/2)2p (1–p)/d2 = (1.96)²0.535(1–0.535)/(0.03)². 10% of the initial sample size was added for non-response rate and the final sample size was 1,168. Proportional allocation of participants was employed to allocate the sample size among the selected general hospitals based on caseload (Fig 1).

Sampling procedure

Ten out of fourteen public general hospitals were selected through a simple random sampling technique, and all general hospitals were not included because of budget constraints. Participants were selected using a systematic random sampling method whereby the first patient was selected randomly from the first three by a lottery method, and the next patient was selected every three intervals until the required sample was attained.

Data collection tool and measurement

The data were collected using a pre-tested, interviewer-administered questionnaire that was developed based on relevant literature [12,21,31,32] and record review. It has four parts: part one was used to collect data about socio-demographic characteristics; part two was on clinical characteristics; part three was on behavioural factors; and part four was on chronic diabetes complications. Behavioural variables were assessed based on the WHO TEPwise approach for chronic disease risk factor surveillance [33]. Clinical variables were taken from the patient’s chart/medical record and physical measurements. Body weight was measured to an accuracy of 0.1 kg using a weight scale machine and the patient was barefoot and wearing light clothing. Height was measured in meters, standing upright on a flat surface, by a stadiometer. Body Mass Index (BMI) was calculated as the ratio of weight in kilogram (kg) to the square of height in meters (m2). Systolic blood pressure (BP) and diastolic blood pressure (DBP) was measured from the left arm at the level of the heart using a mercury-based or digital sphygmomanometer after the patient took a rest for more than 10 minute and 1–2 hour for those who took hot drink like coffee [34]. For those patients with BP ≥ 140 mm of mercury (mmHg) and/or DBP ≥ 90 mmHg, blood pressure was measured again, and finally, the average value was taken.

Data collection procedure

The T2D patients attending 10 hospitals during the data collection period were approached by the data collectors, verified for eligibility and then, after informed consent was obtained, data were collected. Data was collected by ten BSc nurses who had either MPH or MSc with multilingual abilities and were supervised by the first and third authors. The type 2 diabetic patients were identified by examining their diagnosis as reported in the medical record. Moreover, clinical and chronic diabetic complications data were extracted from patients’ medical records. The diagnosis of chronic diabetic complication was then confirmed by the physician.

Data management and analysis

To assure data quality, training and orientation of the study were done for the data collectors and supervisors and the questionnaire was pre-tested and checked for its validity and reliability. The pretest of the questionnaire involved 2% of the sample size and it was carried out in Quiha general hospital two weeks before the actual data collection. The questionnaire was revised based on the pre-test results. The questionnaires were checked for completeness and consistency on the daily bases. The data was entered and cleaned, entered in the SPSS version 20 analyses were performed using. A binary logistic regression analysis model was used to identify factors associated with chronic diabetes complications. The Homer-Lemehow goodness-of-fit test was used to check the model fitness and the assumption of a P-value >0.05 was considered a good model fit. Independent variables with p < 0.20 during the bivariate analysis were then included in the multivariable logistic regression for further analysis to control confounding factors. Multicollinearity between independent variables was checked by using the tolerance test and variance inflation factor (VIF). P < 0.05 was considered the cut-off point for reporting an independent variable that shows a statistically significant association with the dependent variable in multivariate analysis. The strength of the association of factors with chronic diabetes complications was demonstrated by computing the adjusted odd ratio (AOR) and its 95% confidence interval (CI).

Variables of the study

Independent variable

Socio-demographic: age, sex, marital status, religion, ethnicity, educational status, occupation, residence, monthly income (UD), family history of diabetes and BMI.

Clinical: diabetes treatment regimen, anti-platelet drug (e.g., AA), anti-dyslipidemia drug, glucometer, duration of diabetes, Fasting Blood Glucose (FBG), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Pill burden, and high health care cost.

Behavioural: adherence to a diabetic diet, saturated fat consumption, vegetable consumption, adherence to diabetic medication, self-blood glucose test, smoking, alcohol consumption, physical activity, and diabetes education.

Dependent variable

Chronic diabetes complications status

Operational definition

The data about chronic diabetes complications were extracted from the patient’s chart/medical record. Only chronic complications that developed after the diagnosis of T2D and could be attributed to diabetes were considered in this study.

Diagnosis of chronic diabetes complication

Hypertension: was defined as systolic blood pressure (SBP) ≥ 140 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg, and/or patient on antihypertensive therapy was taken as the hypertensive patient [35,36].

Coronary artery disease (CAD): The diagnosis criteria for CAD were either a patient with typical anginal pain or equivalent symptoms or an abnormal resting ECG or an asymptomatic patient with the abnormal stress test, either by ECG or echo or a nuclear perfusion imaging test [37].

Peripheral vascular disease: The presence of intermittent claudication and/or an ABI (ankle-brachial/Arm index) value (< 0.9) in any limb was recorded as peripheral vascular disease [38].

Neuropathy: was diagnosed if a change was found in two or more of the three items hypesthesia or anaesthesia in lower and upper limbs when the patient’s lower limp was evaluated [18].

Eye diseases: Eye diseases such as cataracts, glaucoma and diabetic retinopathy were identified based on the report of the ophthalmologist or optometrist from the dilated eye (fundus photography for retinopathy), and comprehensive eye examination, which was recorded on the patient’s chart [18].

Chronic Kidney disease: was diagnosed based on the presence of urinary albumin(micro or macro albuminuria), and/or an abnormally high level of serum creatinine (low glomerular filtration rate) [39].

Foot problem: The diagnosis of foot problem was made through foot examination for any abnormalities (i.e. dry kin, fissure, deformities, callosities, ulceration, prominent vein, and nail lesion) or all patients were asked about a history of foot ulcer, neuro ischemic foot, or amputation [40].

Follow a healthy diet: consuming vegetables, beans and peas, fruit, whole grain, nut, and seeds, seafood, low-fat milk and milk product, and a moderate amount of lean meat, poultry, and egg [41,42].

High fat/oil consumption: eat or consume more than 10% of calories from saturated fat, which means more than 20 grams of saturated fat per day [43,44].

Alcohol consumption: Adult with diabetes who drinks alcohol should do so in moderation (no more than one drink per day for adult women and no more than two drinks per day for adult men). One drink is defined as 12 oz/355ml of beer, 5 oz /148ml glass of wine, or 1.5 oz/44ml of distilled spirit [45].

Physical activity: At least 150 minutes per week of aerobic exercise, plus at least two seasons per week of resistance exercise, are recommended [46].

Ethical considerations

Ethical approval to conduct the study was obtained from the Institutional Review Board (IRB) of Mekelle University (Ref No. ERC 1370/2019). The study received approval from the Tigray regional health bureau and permission from the Medical Directors of the 10 involved hospitals. The study was conducted following the declaration of Helsinki. Study participants were recruited voluntarily after they were informed about the study and that they can withdraw from the study at any stage thereafter they signed the consent form. All data were kept in a safe and secure place anonymously to ensure confidentiality and only the researchers had access to the data.

Results

Socio-demographic characteristics of the participant

Overall, a total of 1,168 diabetic individuals were eligible for the study, but only 1,158 of the participant’s questionnaires were fit for final analysis, which makes the response rate 99.14 per cent. Thirty-four per cent of the participants had an age greater than 60 years, with a mean age of 55.9 (D± 11.9) years. Most of the participants were male (54%), Married (67%), Orthodox Christian (88%), Tigrian ethnicity (96.3%), and urban resident (72.3%). Majority of the participants: 50.5% had no formal education, 80.3% had no family history of diabetes, 29.7% were unemployed, 7.9% had a monthly income of $34.26-$171.16 and 76.5% had a BMI of <25 kg/m2 [Table 1].

Table 1. Socio-demographic characteristics by chronic diabetes complication among diabetic patients attending the general hospitals in Tigray region, Northern Ethiopian, 2019/2020 (N = 1,158).

Variable	Category	Chronic DM complication status		Total
Variable	Category	No (n = 530)	Yes (n = 628)	Total
Age	≤40 year	88(7.6%)	49(4.2%)	137(11.8%)
	41–45 year	59(5.1%)	41(3.5%)	100(8.6%)
	46–50 year	96(8.3%)	89(7.7%)	185(16.0%)
	51–55 year	76(6.6%)	76(6.6%)	152(13.1%)
	56–60 year	93(8.0%)	103(8.9%)	196(16.9%)
	≥61 year	118(10.2%)	270(23.3%)	388(33.5%)
Sex	1. Male	285(24.6%)	340(29.4%)	625(54.0%)
Sex	2. Female	245(21.2%)	288(24.9%)	533(46.0%)
Marital status	1. ingle	39(3.4%)	38(3.3%)	77(6.6%)
	2. Married	380(32.8%)	394(34.0%)	774(66.8%)
	3. Divorced	47(4.1%)	84(7.3%)	131(11.3%)
	4. Widowed	64(5.5%)	112(9.7%)	176(15.2%)
Religion	1. Orthodox	474(40.9%)	545(47.1%)	1019(88.0%)
	2. Muslim	50(4.3%)	79(6.8%)	129(11.1%)
	3. Catholic	6(0.5%)	4(0.3%)	10(0.9%)
Ethnicity	1. Tigrian	508(43.9%)	607(52.4%)	1115(96.3%)
	2. Amhara	19(1.6%)	19(1.6%)	38(3.3%)
	3. Afar	3(0.3%)	2(0.2%)	5(0.4%)
Educational status	1. No formal education	246(21.2%)	339(29.3%)	585(50.5%)
	2. Primary school (1–8 grade)	118(10.2%)	134(11.6%)	252(21.8%)
	3. Secondary (9–12 grade)	89(7.7%)	80(6.9%)	169(14.6%)
	4. College/University	77(6.6%)	75(6.5%)	152(13.1%)
Occupation	1. Farmer	119(10.3%)	129(11.1%)	248(21.4%)
	2. Gov’t employee	103(8.9%)	62(5.4%)	165(14.2%)
	3. Private work	135(11.7%)	146(12.6%)	281(24.3%)
	4. Retired	42(3.6%)	78(6.7%)	120(10.4%)
	5. Unemployed	131(11.3%)	213(18.4%)	344(29.7%)
Residence	1. Urban	370(32.0%)	467(40.3%)	837(72.3%)
Residence	2. Rural	160(13.8%)	161(13.9%)	321(27.7%)
Monthly income (UD)	< $34.23	157(13.6%)	234(20.2%)	391(33.8%)
	2, $34.26–171.16	324(28.0%)	351(30.3%)	675(58.3%)
	3, >$171.16	49(4.2%)	43(3.7%)	92(7.9%)
Family history of DM	1.Ye	102(8.8%)	126(10.9%)	228(19.7%)
Family history of DM	2. No	428(37.0%)	502(43.4%)	930(80.3%)
BMI	< 25 kg/m2	466(40.2%)	420(36.3%)	886(76.5%)
BMI	≥ 25 kg/m2	162(14.0%)	110(9.5%)	272(23.5%)

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T2D: Type 2 diabetes, DM: Diabetes mellitus, BMI: Body Ma Index, DM: Diabetes Mellitus, UD: United States Dollar.

Clinical and behavioural characteristics of the participants

Of the total patients included in this study, 78.9%, 11.7%, and 16.8% were taking oral hypoglycemic agent (OHGA), anti-coagulant drug, and anti-dyslipidemia drug respectively. The mean duration of diabetes was 6.3 (D ± 4.6) years and 54.6% of participants had diabetes duration of < 5 years. Of all participants, 10.1% had a glucometer at home, 60.7% had FBG of >130.00 mg/dl, 25.8% had SBP of >149.00 mmHg and 9.0% had DBP of > 90.00 mmHg. From the total participants, 42.7% were taking >4 pills per day, 86.4% had a high health care cost, 69.7% consumed a high amount of saturated fat (>20 g per day), and 68.7% were taking less than the recommended amount of vegetable (<4 serving per week). Of all participants, 90.6% and 50.4% adhered to diabetes medication and a healthy diet. Of the total participants, nine out of ten test their blood glucose once per month, 6.2% ever smoke tobacco product, 12.4% consume more than moderate amount of alcohol (≥3 drink per day). Moreover, of the total participants, 61.3% were active physically, and 76.5% were attending diabetes education at the time of follow visit [Table 2].

Table 2. Clinical and behavioural characteristics by chronic diabetes complication among diabetic patients attending the general hospitals in Tigray region, Northern Ethiopian, 2019/2020 (N = 1,158).

Variable	Category	Chronic DM complication status		Total
Variable	Category	No (n = 530)	Yes (n = 628)	Total
Diabetes treatment regimen	Inulin (injectable)	78(6.7%)	61(5.3%)	139(12.0%)
	Inulin & OHGA^*	33(2.8%)	72(6.2%)	105(9.1%)
	OHGA^*	419(36.2%)	495(42.7%)	914(78.9%)
Use of anti-platelet drug (e.g. AA)	1, Ye	20(1.7%)	116(10.0%)	136(11.7%)
Use of anti-platelet drug (e.g. AA)	No	510(44.0%)	512(44.2%)	1022(88.3%)
Use of anti-dyslipidemia drug	Ye	45(3.9%)	150(13.0%)	195(16.8%)
Use of anti-dyslipidemia drug	No	485(41.9%)	478(41.3%	963(83.2%)
Have glucometer at home	Ye	47(4.1%)	70(6.0%)	117(10.1%)
Have glucometer at home	No	483(41.7%)	558(48.2%)	1041(89.9%)
Duration of diabetes since it occurred	< 5 year	345	287(24.8%)	632(54.6%)
Duration of diabetes since it occurred	≥ 5 year	185(16.0%)	341(29.4%)	526(45.4%)
FBG test	<130.00 mg/dl	200(17.3%)	255(22.0%)	455(39.3%)
FBG test	≥ 130.99 mg/dl)	330(28.5%)	373(32.2%)	703(60.7%)
Systolic blood pressure (SBP)	≤ 139.99 mmHg	459(39.6%)	400(34.5%)	859(74.2%)
Systolic blood pressure (SBP)	≥140.00 mmHg	71(6.1%)	228(19.7%)	299(25.8%)
Diastolic blood pressure (DBP)	≤ 89.99 mmHg	503(43.4%)	551(47.6%)	1054(91.0%)
Diastolic blood pressure (DBP)	≥90.00 mmHg	27(2.3%)	77(6.6%)	104(9.0%)
Pill burden	<4 pills/day	360(31.1%)	304(26.3%)	664(57.3%)
Pill burden	≥ 4 pills /day	170(14.7%)	324(28.0%)	494(42.7%)
High healthcare cot	1. Ye	451(38.9%)	550(47.5%)	1001(86.4%)
High healthcare cot	2. No	79(6.8%)	78(6.7%)	157(13.6%)
Adherence to a diabetic diet	Adhere	264(22.8%)	320(27.6%)	264(22.8%)
Adherence to a diabetic diet	Not adhere	266(23.0%)	308(26.6%)	266(23.0%)
Saturated fat consumption	< 20 gm. fat/day	143(12.3%)	208(18.0%)	351(30.3%)
Saturated fat consumption	≥ 20 gm. fat/day	387(33.4%)	420(36.3%)	807(69.7%)
Vegetable consumption per week	<4 serving	370(32.0%)	425(36.7%)	795(68.7%)
Vegetable consumption per week	≥ 4 serving	160(13.8%)	203(17.5%)	363(31.3%)
Adherence to diabetic Medication	Adhere	486(42.0%)	563(48.6%)	1049(90.6%)
Adherence to diabetic Medication	Not adhere	44(3.8%)	65(5.6%)	109(9.4%)
Day, in which glucose was measured/wk.	Not measured at all	488(42.1%)	566(48.9%)	1054(91.0%)
Day, in which glucose was measured/wk.	1–2 day	42(3.6%)	62(5.4%)	104(9.0%)
Ever smoked tobacco products (smoking)	Ye	27(2.3%)	45(3.9%)	72(6.2%)
Ever smoked tobacco products (smoking)	No	503(43.4%)	583(50.3%)	1086(93.8%)
Alcohol consumption	≥ 3 drinks per day	62(5.4%)	82(7.1%)	144(12.4%)
Alcohol consumption	≤ 2 drinks per day	468(40.4%)	546(47.2%)	1014(87.6%)
Physical activity	Inactive	174(15.0%)	274(23.7%)	448(38.7%)
Physical activity	Active	356(30.7%)	354(30.6%)	710(61.3%)
Attend diabetes education	Ye	345(36.1%)	387(40.4%)	732(76.5%)
Attend diabetes education	No	102(10.7%)	123(12.9%)	225(23.5%)

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*OHGA = Oral Hypoglycemic Agent, T2D: Type 2 diabetes, ASA: Acetylsalicylic Acid, FBG: Fasting Blood Glucose, SBP: systolic Blood Pressure, DBP: Diastolic Blood Pressure.

The magnitude of chronic diabetes complication

Overall, 54% of participants (95% CI 51.35, 57.10) suffered from at least one chronic complication of diabetes. Among all participants who had the complication, 10.5% had a single complication, 16.9% lived with two and 26.8% with more than two types of complications respectively.

Macrovascular complication

Of all types of macrovascular complications, hypertension 27% (95% CI 24.71,29.85) was the most common but cerebrovascular disease 4.31% (95% CI: 3.14, 5.49) was the least common type. Out of all participants who had cerebrovascular complications, 0.3% had TIA and 4% had a history of stroke (Fig 2).

Microvascular complication

The most common type of microvascular complication was ocular disease 22.62% (95% CI 20.21, 25.03), followed by kidney disease 19.17% (95% CI 16.90, 21.44) and peripheral neuropathy11% (95% CI 8.84, 12.39) respectively. Patients with renal complications consisted of 9% with microalbuminuria,4.0% with macroalbuminuria and 6% with high levels of serum creatinine. Ocular complications included cataracts, retinopathy, diabetes blindness and glaucoma, with magnitudes of 5%, 9%, 1% and 8% respectively. Of the total participant who had a foot disease, 4% had a diabetes-related foot ulcer, 1% had a foot amputation, 3.6% had ischemic pain, 1% had gangrene and 3% had an infection (Fig 3).

Factor associated with chronic diabetes complication among patients with type 2 diabetes (T2D)

The Homer-Lemehow goodness-of-fit test was done, and its result showed P = 0.0063, which was considered a good model fit. The odds ratio was calculated for factors found to be associated with chronic diabetes complications among type 2 diabetic patients. After considering all assumptions of binary logistic regression and the p-value (≤ 0.05) in the bivariate analysis, fifteen variables were identified as candidates for analysis in the multivariable model. In the multivariable logistic regression analysis, nine variables were found to be factors associated with chronic diabetes complications at a 5% level of significance.

The odds of a chronic diabetes complication was higher among patients age > 60 years (AOR = 3.00; 95% CI 1.73,5.26)) than their counterpart, who took insulin and OHA had a higher chance of developing the complication (AOR = 2.20; 95% CI 1.18, 4.27) than patients taking insulin injection only, with diabetes duration of ≥ 5 years, were at higher risk to develop the complication (AOR = 1.56; 95% CI 1.18, 2.05) than patients with shorter diabetes duration and who took ≥4 pills a day had a greater risk to develop chronic diabetes complication (AOR = 1.63; 95% CI 1.23, 2.15) than their counterpart [Table 3]. Similarly, the odds of a chronic diabetes complication was higher among patient with a higher systolic BP (≥140.00 mm Hg.) or diastolic BP (≥ 90.00 mm Hg.) (AOR = 3.13; 95% CI 2.25, 4.35) and (AOR = 1.39; 95% CI 1.06, 1.81) than participants with lower systolic BP (<139.99 mmHg.) or diastolic BP (<79.99 mm Hg.) respectively. Whereas, patients who were government employees (AOR = 0.48; 95% CI 0.26, 0.90), taking anti-platelet drugs (AOR = 0.29; 95% CI 0.16, 0.52) and anti-dyslipidemia drugs (AOR, = 0.54; 95% CI 0.35, 0.84) were less likely to develop the complication than the patients who were unemployed and did not take anti-platelet and anti-dyslipidemia, respectively [Table 3].

Table 3. Factors associated with chronic diabetes complication among diabetic patients attending the general hospitals in Tigray region, Northern Ethiopian, 2019/2020 (N = 1,158).

Variable	Category	Chronic DM complication		OR (95% CI)
Variable	Category	No	Yes	COR	P	AOR
Age	≤40 year	88 (7.6%)	49(4.2%)	1		1
	41–45 year	59(5.1%)	41(3.5%)	1.2(0.73, 2.12)	0.423	1.26(0.70, 2.26)
	46–50 year	96(8.3%)	89(7.7%)	1.6(1.05, 2.61)	0.163	1.44(0.86, 2.41)
	51–55 year	76(6.6%)	76(6.6%)	1.7(1.12, 2.88)	0.399	1.26(0.73, 2.20)
	56–60 year	93(8.0%)	103(8.9%)	1.9(1.27, 3.11)	0.208	1.39(0.83, 2.35)
	≥61 year	118(10.2%)	270(23.3%)	4.1(2.72, 6.19)	0.000	2.51(1.50, 4.18) ^***
Marital status	1. Single	39(3.4%)	38(3.3%)	1.0(0.66, 1.70)	0.221	1.51(0.77, 2.94)
	2. Married	380(32.8%)	394(34.0%)	1.8(1.03, 3.25)	0.926	1.01(0.67, 1.53)
	3. Divorced	47(4.1%)	84(7.3%)	1.7(1.04, 3.08)	0.059	1.68(0.98, 2.89)
	4. Widowed	64(5.5%)	112(9.7%)	1		1
Educational status	1. Illiterate	246(21.2%)	339(29.3%)	1.4(0.98, 2.02)	0.142	0.64(0.36, 1.15)
	2. Primary school	118(10.2%)	134(11.6%)	1.1(0.77, 1.74)	0.210	0.69(0.39, 1.22)
	3. secondary school	89(7.7%)	80(6.9%)	0.9(0.59, 1.43)	0.238	0.71(0.40, 1.24)
	4. College/University	77(6.6%)	75(6.5%)	1		1
Occupation	1. Farmer	119(10.3%)	129(11.1%)	0.6(0.47, 0.92)	0.946	0.98(0.62, 1.54)
	2. Gov’t employee	103(8.9%)	62(5.4%)	0.3(0.25, 0.54)	0.023	0.48(0.26, 0.90) ^*
	3. Private work	135(11.7%)	146(12.6%)	0.6(0.48, 0.91)	0.552	0.87(0.57, 1.35)
	4. Retired	42(3.6%)	78(6.7%)	1.1(0.74, 1.76)	0.532	1.19(0.68, 2.09)
	5. Unemployed	131(11.3%)	213(18.4%)	1		1
Monthly income (UD)	< $34.23	157(13.6%)	234(20.2%)	1.6(1.07, 2.68)	0.340	1.35(0.72, 2.50)
	34.26–171.16	324(28.0%)	351(30.3%)	1.2(0.79, 1.91)	0.356	1.28(0.75, 2.19)
	>171.16	49(4.2%)	43(3.7%)	1		1
BMI	< 25 kg/m2	466(40.2%)	420(36.3%)	1		1
BMI	≥ 25 kg/m2	162(14.0%)	110(9.5%)	1.3(1.00, 1.74)	0.994	0.99(0.72, 1.38)
Diabetes treatment regimen	Inulin (injectable)	78(6.7%)	61(5.3%)	0.6(0.46, 0.94)	0.754	0.93(0.60, 1.44)
	Inulin & OHA^*	33(2.8%)	72(6.2%)	1.8(1.19, 2.84)	0.000	2.45(1.49, 4.01) ^***
	OHGA^*	419(36.2%)	495(42.7%)	1		1
Anti-platelet drug	Ye	20(1.7%)	116(10.0%	1		1
Anti-platelet drug	No	510(44.0%)	512(44.2%	0.1(0.10, 0.28)	0.000	0.29(0.16, 0.52) ^***
Anti-dyslipidemia drug	Ye	45(3.9%)	150(13.0%)	1		1
Anti-dyslipidemia drug	No	485(41.9%)	478(41.3%	0.2(0.20, 0.42)	0.006	0.54(0.35, 0.84) ^**
Duration of diabetes	< 5 year	345(29.8%)	287(24.8%)	1		1
Duration of diabetes	≥ 5 year	185(16.0%)	341(29.4%)	2.2(1.74, 2.81)	0.001	1.56(1.18, 2.05) ^**
Systolic blood pressure (SBP)	< 139.99 mmHg	459(39.6%)	400(34.5%)	1		1
Systolic blood pressure (SBP)	≥140.00 mmHg	71(6.1%)	228(19.7%)	3.6(2.73, 4.96)	0.000	3.13(2.25, 4.35) ^***
Diastolic blood pressure (DBP)	< 89.99 mmHg	503(43.4%)	551(47.6%)	1		1
Diastolic blood pressure (DBP)	≥ 90.00 mmHg	27(2.3%)	77(6.6%)	1.6(1.27, 2.03)	0.016	1.39(1.06, 1.81) ^*
Pill burden	<4 pills/day	360(31.1%)	304(26.3%)	1		1
Pill burden	≥ 4 pills/day	170(14.7%)	324(28.0%)	2.2(1.77, 2.87)	0.001	1.63(1.23, 2.15) ^**
High saturated fat consumption	< 20 gm. fat/day	143(12.3%)	208(18%)	1		1
High saturated fat consumption	≥ 20 gm. fat/day	387(33.4%)	420(36.3%)	0.7(0.57, 0.96)	0.111	0.78(0.58, 1.05)
Physical activity	Inactive	174(15.0%)	274(23.7%)	1.5(1.24, 2.01)	0.070	1.31(0.97, 1.77)
Physical activity	Active	356(30.7%)	354(30.6%)	1		1

Open in a new tab

*OHGA: oral hypoglycemic agent

*significant at p<0.05

**significant at p<0.01

***significant at p< 0.0001., Homer-Leme how goodness-of-fit (P = 0.0063), BMI: Body Ma Index.

Discussion

This study aimed to assess the magnitude of chronic diabetes complications and associated factors among diabetic patients attending the general hospitals in the Tigray region, Northern Ethiopia. The overall magnitude of chronic diabetes complications in this study was 54.0% (95% CI: 51.35, 57.10). This is consistent with studies from Bahir Dar, Northwest Ethiopia (54%), and China (52%) [12,21]. The finding of this study was lower than the magnitude reported in Libya(69%), Indonesia (69%), Gurage zone, South Ethiopia(61%), Saudi Arabia(66%) and Nepal (72%) [47–51]. The probable cause for the higher prevalence reported in other studies compared to our study could be due to the presence of age, diabetes duration, and BMI differences. For instance, a study in Indonesia reported that 46% of study participants were aged >60 years old; in Indonesia, Ethiopia, Saudi Arabia, and Nepal, patients with ≥5 years of diabetes duration were 73%, 53%, 46%,46% and 91%, respectively; and participants from a study in Saudi Arabia and Nepal with normal BMI were 17% and 20% respectively.

However, our study showed that 34%, 45% and 77% of the study participants were >60 years of age, with ≥ 5 years of diabetes duration and normal BMI respectively. However, the result of this study is higher than a study in Gurage Zone, Southwest Ethiopia (46%). [21] The probable reason for the higher prevalence reported in our study compared to a study in Gurage Zone, south Ethiopia, could be due to ample size, study setting, and population variation. The study was done using a very small sample size and conducted in both the primary and general hospitals among type 1 and type 2 patients.

In this study, 27.28% (95% CI: 24.71, 29.85) participants had diabetes-related hypertension which is in line with a study done in Jimma, Ethiopia(25%) [15]. This is higher than studies from Palestine (23%), the town of Hosaena, Southern Ethiopia (23.9%) and Saudi Arabia (20%) [52–54]. The reason for the high prevalence in our study as compared to studies conducted in Palestine, Ethiopia and Saudi Arabia might be because of differences in the male-to-female ratio, time at which the study was conducted and study area. The result of this study is lower than studies conducted in Bangladesh (82%), Iraq (38%), Libya (33%), West Ethiopia (42%) and Jimma, Ethiopia (42%) [15,47,55–57]. The variation might have occurred because in this study only participants who became hypertensive after the occurrence of diabetes were considered, whereas the other studies may have included all participants who developed hypertension before and after the diagnosis of diabetes. Moreover, the presence of age, diabetes duration, and BMI differences may contribute to such variation.

In this study, peripheral vascular disease was seen among 9.13% (95% CI: 7.49, 10.81) participants, which is higher than the finding from a survey conducted in Sri Lanka (4.7%) [32,58]. The reason for the higher value of our study might be because of genetic variability, patients’ poor adherence to medication, and practice related to lifestyle recommendations. However, the result of this study is lower than India (12%), Bangladesh (14%) and Libya (15%) [59–61]. This variation occurred due to our study population remained without a diagnosis for years because of a lack of awareness and access to advanced diagnostic tests.

Coronary artery disease (CAD)occurred among 3.28% (95% CI 2.25, 4.30) participants in this study, which is lower than studies done in Sri Lanka (11%), Saudi Arabia (23%), Bangladesh (26%), India (8%), Nepal (23%), and Iraq (15%) [32,60,62–64]. The reasons for the lower result of this study compared to the other studies are our study participants might have had a late diagnosis of diabetes, late initiation of treatment, or lifestyle modification, and a lack of access to advanced diagnostic studies like stress tests, echocardiography and nuclear perfusion imaging test. Moreover, genetic and racial variability may play a role in such discrepancy.

Of the total participants in this study, 4.31% (95% CI 3.14, 5.49) had a stroke, which is higher than studies done in Libya (1.9%), Saudi Arabia (0.19%), Nepal (1%) and Iraq (0.7%) [47,51,54,56]. The reason for the higher value of our result might be due to over-reporting, a larger sample size, and the late initiation of diabetes treatment or lifestyle recommendations compared to other studies, but this result is lower than India (7%), Bangladesh (11%), and Indonesia (18%) [59,60,65]. The reason for our study’s lower figure could be participants in other studies were older, had a higher rate of obesity, and had diabetes for a longer time. In addition, socio-cultural variations and genetic predisposition play a role in the variation.

Peripheral neuropathy was seen among 11% (95% CI 8.84, 12.39) participants; this finding is almost similar to that of studies conducted in India (11%) and West Ethiopia (10%) [66,67]. The reason for the similarity could be due to the population characteristics, mainly the socio-demographic characteristics, being relatively similar.

This result is higher than the result of Saudi Arabia (1.4%) and Iraq (6.5%) [54,56]. The reason for the higher figure in this study could be due to socio-demographic characteristics variation; for instance, in this study, only T2D patients were included, and 28% of participants were from the rural area, whereas the study from Iraq included both types 1 and type 2 diabetes, and more than 53% of participants in the Saudi Arabia study were rural resident.

However, it is lower than the result of Sri Lanka (63%), Southwest Ethiopia (15%), Nepal (15%), Bangladesh (28%), India (19%), Tanzania (29%), and Egypt (22%) [32,49,51,60,62,68,69]. The probable reason for the lower figure in our study could be the lower rate of progression and the low onset of the disease, which discourage patients from seeking treatment early. In addition, a lack of routine foot examinations by senior experts could result in underreporting or miss diagnosis of such cases.

In this study the magnitude of diabetes nephropathy was 19.17%(95%CI: 16.90,21.44) this figure is in line with the study conducted in Ethiopia [15]. Unlike our study, Sri Lanka (51%), Nepal (25%), Bangladesh (43%), India (41.1%), Egypt (67%) and Sudan (39%) Studies have found higher percentages of participants with nephropathy [32,51,60,62,69,70]. The reason for the lower finding of our study might be ethnicity, racial, and socio-demographic characteristics difference, which play a major role in the development of diabetic nephropathy. However, our result is higher than the findings of studies in Tanzania (12%), China (11%), India (10.5%), Ethiopia (11.4%), Saudi Arabia (4.2%), and Iraq (14.2%) [12,21,63,64,66,68]. The higher result in our study could be because in this study all forms of kidney disease were included, whereas in the other studies, microalbuminuria, macro albuminuria and high level of serum creatinine were reported separately. Moreover, genetic and socio-demographic variability may play a role.

In this study, retinopathy was seen in 9% (95% CI: 7.25–10.53) of participants, which is in line with studies conducted in Indonesia (7%), Tunisia (8.1%), Iraq (7.5%), and Ethiopia (10%) [16,64,65,69] and higher than a survey done in India (4.8%) and Saudi Arabia (3%) [63,66]. The probable reason for the higher value in this study could be attributed to the lack of awareness among our patients about the importance of regular eye examinations. Moreover, the patient’s poor medication adherence, knowledge, and attitude might have contributed to such a difference.

However this result is lower than research findings done in Ethiopia (26%), Sri Lanka (26%), SSA (15%), Nepal (29%), Korea (38%), India (15.4%), Bangladesh (38%), Libya (31%), Tanzania (50%), Sudan (14%), and Egypt (21%) [21,32,35,51,58–61,68,70,71]. The rationale for the lower figure of this study compared to the other studies might be the lack of access to the regular dilated fundus examination technique due to it is not available at general hospitals. Hence, diabetic patients rarely check on their visual status in the absence of a symptom.

In this study, 4.14% (95% CI 2.99, 5.29) of the participants had a diabetes-related foot ulcer, which is similar to the study finding in Sri Lanka (2.6%), Korea (4.4%), Saudi Arabia (2.17%), Nepal (5%), and Ethiopia (5%) [15,32,51,58,63] and higher than China, Iraq (0.8%), Libya (1.1%), Sri-Lanka (1.3%), and Ethiopia. [12,32,61,64,67] (1.2%). This difference may be due to the small sample size and study population variation. However, this finding is lower than studies done in the North, South, and BLH, Ethiopia (21.2%, 20.4%, and 17%, respectively) [16,21,49]. The justification for the lower finding of our study could be due to underreporting and patients were not received regular foot examinations by a senior expert.

In this study, age, occupation, diabetes treatment regimen, anti-platelet drug, anti-dyslipidemia drug, duration of diabetes, systolic BP, diastolic BP and Pill burden were variables showing statistical association with the occurrence of diabetes complications. Similarly, the age of the participant, diabetes treatment regimen and/or duration of diabetes were also identified as factors associated with chronic diabetes complications in studies in, China, Ethiopia, and Libya [12,21,61].

However, gender, marital status, BMI, poor glycemic control, dyslipidemia, and family history of diabetes do not show association in this study, but gender in Libya and Iraq [61,64], marital status and BMI in Ethiopia [49], poor glycemic control in Ethiopia and Libya [49,61], dyslipidemia [61] and family history of diabetes in Libya [61] were identified as factors associated with chronic diabetes complication.

Some of the major limitations of this study that should be mentioned are: First of all, as it was hospital-based cross-sectional in its design, this only allows for the identification of variables that have an association with the dependent variable rather than causation. Second, it could not be generalizable to the entire population and to diabetic patients who don’t receive care in the study area’s public general hospital. Third, some independent variables, such as lipid profile, HgbA1C, and eating pattern for each day, were not taken into consideration. Finally, the target population of this study included diabetic patients who were treated at the general hospital by physicians with limited competence to diagnose and the lack of some diagnostic tests even though the patient had a significantly more complex disease burden.

Conclusion

In this study, more than half participants had at least one chronic diabetes complication. Diabetes-related hypertension was the most prevalent type of chronic diabetes complication, followed by eye and renal disease. Furthermore, chronic diabetes complication was associated with age, occupation, diabetes treatment regimen, an anti-platelet drug, anti-dyslipidemia drug, diabetes duration, systolic BP, diastolic BP, and pill burden. Therefore, healthcare providers managing patients with diabetes should work collaboratively with other stakeholders to ensure that all patients with diabetes are screened for early detection and treatment of complications of diabetes using different approaches and strategies. A future follow-up study should be carried out to investigate the cause of chronic diabetes complications among diabetic patients.

Supporting information

S1 Data set

(SAV)

Click here for additional data file.^{(141KB, sav)}

Acknowledgments

We would like to acknowledge all staff of referral clinic of the elected public general hospital for their support, the participant for kindly giving the required information, supervisor and data collector.

Abbreviations

AOR: Adjusted Odd ratio
COR: Crud Odd Ratio
CI: Confidence Interval
BMI: Body Ma Index
EFY: Ethiopian Fiscal Year
FB: Fasting Blood Sugar
HDL: High-Density Lipoprotein
LDL: Low-Density Lipoprotein
AMP: Amputation
OHA: Oral Hypoglycaemic Agent
RB: Random Blood Glucose
SD: Standard Deviation
SPSS: Statistical Package for Social Science
T2D: Type 2 Diabetes
TIA: Transit Ischemic Attach
WHO: World Health Organization
BP: Blood Pressure
BP: Systolic Blood Pressure
DBP: Dystonic Blood Pressure
HgbA1C: Glycolated Hgb
IRB: Institutional Review Board
ERC: Ethical Review Committee
IDF: International Diabetes Federation and mmHg: mm of mercury

Data Availability

All relevant data are within the paper and its Supporting Information files.

Funding Statement

The author(s) received no specific funding for this work.

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PLoS One. 2023 Aug 25;18(8):e0290240. doi: 10.1371/journal.pone.0290240.r001

Author response to previous submission

8 Jun 2022

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Submitted filename: Response to reviewer.docx

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PLoS One. doi: 10.1371/journal.pone.0290240.r002

Decision Letter 0

Manal S Fawzy

9 Mar 2023

PONE-D-22-12568Magnitude of Chronic diabetes complication and its associated factors among adults with type 2 diabetes in Tigray region, northern EthiopiaPLOS ONE

Dear Dr. Berhe,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Partly

Reviewer #2: Yes

**********

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

**********

3. Have the authors made all data underlying the findings in their manuscript fully available?

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Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Is the manuscript presented in an intelligible fashion and written in standard English?

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Reviewer #1: No

Reviewer #2: No

**********

5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: This article can be made simpler for the scientific community with some modifications and clarifications as below.

Minor comments

1. Consistently use either “Tigray” or “Tigrai” in the title, author affiliation, study area, and elsewhere.

2. Change “north Ethiopia / northern Ethiopia” to “Northern Ethiopia” throughout the manuscript

3. Instead of saying "an institutional-based study," say “a multi-center cross-sectional study." since the study was conducted in ten public general hospitals.

4. It is better to say 54% rather than 54.0%, and 27% rather than 27.0%.

5. Throughout the manuscript, apply comma for numbers with more than two digits, like instead of saying 60 000–100 000 people, better to say 60,000-100,000 people.

6. Remove double full stops throughout the manuscript

7. Since it is an international journal, better to change the income status that you mentioned in Ethiopian birr (ETB) to US dollar using the exchange rate at the date of data collection.

8. I recommend you to avoid writing formulas for sample size calculations, it would be better to make it in sentence format the approach you applied for calculating the sample size than writing detailed mathematical equations.

9. Remove the Hosmer-Lemeshow goodness-of-fit test result you mentioned in the method section and put it at the result section (particularly at the multivariable regression table), At the method section you have to mention what you have did not what you found.

10. Add your response rate in the result section, as your study is a cross-sectional study

11. I appreciate writing of the findings of the measure of effect (AOR with its 95% CI), make it consistent in the result section of the manuscript (you mentioned [AOR (95% CI) = 0.48(0.26-0.90), P=0.023]), re-write it as you have rightly described in the abstract section.

12. Avoid P-value if used 95% CI instead of writing like ([AOR (95% CI) = 0.48(0.26-0.90), P=0.023]), remove the P-value and re-write it as (AOR=0.48; 95% CI 0.26,0.9), and remove the hyphen (-), rather use comma for writing the 95% CI.

13. Check the reference section, the majority of the citations are appropriate, but there are some references citrated in appropriately, check them again using software’s or manually

14. Make sure whether your questionnaire has three or four parts, there are inconsistencies in their parts mentioned in the data collection tool and measurement part.

Major comments

1. Rationale of the study: You mentioned that the previous studies had a critical methodological limitation, which hindered the scientific community to make any conclusion or judgment? How do you know whether the sample size was small, if appropriately calculated even 10 sample size can be enough? There are more than ten similar articles published elsewhere in the country, including in the region, what was the added value of your study? I would suggest you to re-write it again, considering convincible scientific argument.

2. Did you assess the risk factors? What you assessed was factors associated with chronic diabetic complications, do you think that we can interchangeably use risk factors and factors associated? Can we assess risk factors using simple, classical cross-sectional study design? I recommend you to consistently use the term factors associated, not risk factors in your manuscript.

3. Sample size calculation: It is appreciable that you have used 3% margin of error to maximize the sample size, and your response rate was 94.6%, but after adding 10% non-response rate, the final sample size should be 1,178 not 1,061.

4. Rewrite incomplete sentences, as there are many incomplete sentences, check the spelling and grammar issues, please check again the whole manuscript for spelling and grammar issues (use of present or past tense), I am not comfortable with the write-up.

Reviewer #2: PLOS ONE

PONE-D-22-12568

Research Article

Magnitude of Chronic diabetes complication and its associated factors among adults

with type 2 diabetes in Tigray region, northern Ethiopia

By: kalayou kidanu Berhe,

Mekelle University College of Health Sciences

Mekelle, Tigray ETHIOPIA

Dr Hussein Ismail, Reviewer report to PLOS one December 2022

1. There is a lot of English language errors that need to be corrected, I believe the manuscript needs a professional proofreading before publications. A lot of errors are identified as in the title Chronic (is written with capital letter and it should not).

2. Moreover, there are a lot of abbreviation errors, that need to be corrected, e.g., in the abstract Bsc nurses, OHA, …etc. The manuscript has a lot of abbreviation errors as well, e.g., IDF in the abstract.

3. Title: Magnitude of Chronic diabetes complication and its associated factors among adults

with type 2 diabetes in Tigray region, northern Ethiopia.

The authors stated that they studied 10 general hospitals out of 13 hospitals, and they did not included any referral or primary care centers. So, the selection is based on general hospitals only, there fore it should be mentioned in the title.

My suggestion for the title:

Magnitude of chronic diabetes complication and its associated factors among diabetic patients attending

the general hospitals in Tigray region, northern Ethiopia.

4. METHODS

4.1. Why did not the author include all the 13 general hospitals? I was surprised of taking 10 hospitals and leaving 3 hospitals. Please explain.

4.2. Sampling:

The methods of sampling were explained efficiently. Although, the author in included p=0.535, (p=proportion of chronic diabetes complications) please include the refence you used that stated the complications proportion as 0.535. Sampling is a step the author did before the research; I am surprised that this proportion used in the sampling was 0.535 is the same as the magnitude of diabetes complications which was the main finding of this study. Please explain.

4.3. Regarding the operational definitions, the definition of hypertension the author used was BP> 140/90, I checked the reference used and it was outdated. Reference number 30.

30. Muxfeldt ES NAdR, Salles GF, Bloch KV. Demographic and clinical characteristics of hypertensive patients in the internal medicine outpatient clinic of a university hospital in Rio de Janeiro. Sao Paulo Med J Child Adolesc Behav. 2004;122:87-93.

My suggestion: please update all the operational definitions according to the updated guidelines or manuscript. Regarding hypertension, you may use the American heart association guidelines 2017 or the European Society of cardiology (ESC) guideline 2018. I recommend the ESC because it agrees with the level of 140/90 that you chose.

Moreover, according to guidelines: No caffeine, no smoking, no eating for at least 2 h before measurement. The author stated BP was measured after30 minutes after hot drink as coffee. Please, explain and what is the refence you used?

5. RESULTS

5.1. The author stated in the results

• (….. in which 29.4%, 34.0%, 47.1% and 52.4% participants had chroic diabets complication respectively.)

• in which 42.7%, 10.0% and 13.0% had chronic diabetes complication

respectively.

• had DBP of > 90.00 mmHg in which 6.0%, 32.2% , 19.7% and 6.6%

participants had at least one chronic diabetes complication respectively.

Suggestion:

• Please specify each complication associated with these numbers.

• Please apply this notion along the whole paper.

5.2. Tables: The authors need to put all the abbreviations in the footnote related to each table. Some abbreviations are missing in the footnotes.

6. DISCUSSION

The discussion is well written.

7. CONCLUSION

It highlights the main findings and supported by the study results.

8. Reference

The authors included a lot of outdated refences. As the refences included:

• Reference 10: 1996

• Reference 22: 1965

Suggestion: updating the refences accordingly.

Regarding recent refences: Only one reference (number 35) was published 2020.

**********

6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: Yes: Zenawi Hagos Gufue, Adigrat University, Ethiopia

Reviewer #2: Yes: Hussein M. Ismail, MD Cardiology

**********

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PLoS One. 2023 Aug 25;18(8):e0290240. doi: 10.1371/journal.pone.0290240.r003

Author response to Decision Letter 0

11 Apr 2023

RESPONSE TO REVIEWERS

_______________________________________________________________________________________________________

Response to Reviewer #1

I. Minor comments

1. “Tigray” is used consistently instead of “Tigrai” in the title, author affiliation, study area, and elsewhere in the manuscript ……………………………………………………………………………………………….(Page all)

2. “north Ethiopia / northern Ethiopia” was changed to “ Northern Ethiopia”…………………………(Page all)

3. "an institutional-based study," was replaced by “a multi-center cross-sectional study”…………….(Page1,4)

4. It was corrected as 54% from 54.0% and as 27% from 27.0% and other similar issues corrected throughout the document as per your suggestion .................................................................................................(Page: 2, 8,9,11)

5. Comma was used for numbers with more than two digits (e.g. 60000–100 000 was edited as 60,000-100,000)………...(page all)

6. Double full stops were removed………………………………………………………………………...(page all)

7. The mentioned Ethiopian birr (ETB) in the Monthly income status section(Tables 1,3) was changed in to US dollar based on average exchange rate of 2019…………………………………………………………(Page 9)

8. The formula for sample size calculation was removed and rewrote in sentence format as per your recommendation and checked using StatCalc for population survey via Epi Info 7.0 software………..(Page4,5)

9. The result of Hosmer-Lemeshow goodness-of-fit test was removed from the method section and placed at the result section (Factors associated with chronic diabetes complication & table3 foot note), ……….(Page11)

10. Result of response rate is included/added in the result section of the manuscript………………….........(Page 8)

11. The multi variable analysis result was re-wrote as per your recommendation……………………...(Page 11, 12)

12. In Abstract & result section P-value was removed and re-wrote as (AOR=0.48; 95% CI 0.26, 0.9), and the hyphen (-) was removed instead comma was use for writing the 95% CI……..............................(Page 2, 11,12)

13. In appropriately cited references were checked & corrected via endnote software ...………………(Page 18-21)

14. The questionnaire has four parts, then corrected as “ it has four parts”…………………….……….....(Page 5)

_______________________________________________________________________________________________

II. Major comments

1. Rationale of the study: revised and additional scientific arguments are included ………………(Page 2,3,4)

2. The term “Risk factor” was replaced by “factors associated” and used consistently throughout the manuscript ………………………………………………………………………………………………(Page all)

3. Sample size calculation: …………………………………………………………………………...(Page 2.5,8)

The required sample size (n) was estimated manually using a single population proportion formula and cheeked using STATCALC for population survey via Epi-info version 7 software with assumptions of 95% CI (z = 1:96), d=0.03, and P=0.535.

Therefore the initial sample size was 1061.882 ( ni = (Z1-α/2)2p (1–p)/d2= (1.96)20.535(1-0.535)/(0.03)2 ). However, a refusal rate of 10% (1061.882*0.1) =106.1882 was added and gives a final sample size of 1,168.0702 (1,061.882+106.1882),

Accordingly10 questioners were excluded because of gross incompleteness and 1,158 participants’ questioner were fit for final analysis which makes response rate of 99.14 % ………………………………

4. Incomplete sentences were re-wrote, spelling and grammar issues were checked and corrected…(Page all)

_______________________________________________________________________________________________

___________________________________________________________________________________

Response to Reviewer #2:

Title & abstract

1. Gross English language Proofreading was done to correct errors of Spelling, grammar, punctuation and statement construction throughout the manuscript…………………………………………………. (Page all)

2. To avoid confusion with other similar abbreviations the expanded form of the abbreviations were included e.g. IDF (International Diabetes Federation ), Bsc is corrected as BSc and other abbreviations errors corrected accordingly ……………………………………………………………………………………..(Page 2,10,11 )

3. Research Title was modified as “Magnitude of chronic diabetes complication and its associated factors among diabetic patients attending the general hospitals in Tigray region, northern Ethiopia” based on your suggestion …………………………………………………………………………………………………………(page-1)

________________________________________________________________________________________________

4. Method and materials

4.1 Study Area:: the study was done at 10 general hospitals out of all 14 (not 13, it was written by mistake) general hospitals, all general hospitals were not included because of the four hospitals were exclude randomly due to budget constraint / logistic issue…………………………………………………...(Page4)

4.2 Sampling: A reference (ref.no 21) for P=0.535, (p=proportion of chronic diabetes complications) was included and this figure is used to calculate the sample size which was done in 2015 which was before our study conducted (2019/20) and taken from a study done at FelegeHiwot referral hospital, Bahardar, Amhara region, Northwest Ethiopia…………………………………………………………………..(Page5)

As you mention, by chance the chronic diabetes complication proportion of the study done at FelegeHiwot referral hospital (P=0.535) which we use for sample size calculation is similar to our finding (P=0.54). This could occur because of similarity in socio-demographic characteristics, poor glycemic control as a result of poor adherence to diabetes self-management recommendations……………………… (Page5, 11)

Therefore, the finding of this study (overall magnitude of chronic diabetes complication was p=0.54 or 54% of the patients had at least one type of the complication…………………………………… (Page 11)

But both studies have difference in many things such as sample size (344 vs. 1,158), study facility (one tertiary hospital vs. ten general hospitals), study area (Amhara region vs. Tigray region) and study period (2015 Vs. 2019/20)……………………………………………………………………………….... (Page4-6)

________________________________________________________________________________________________

4.3 Operational definition:

4.3.1 Definition of Hypertension: The reference was updated and replaced by the reference that you recommend “European Society of cardiology (ESC) guideline 2018” (ref.no 33, 34)…………. (Page7,8)

4.3.2 Definition of other chronic diabetes complications: all definition/ diagnostic criteria of other chronic diabetes complications (operational definitions) were updated according to the updated guidelines or manuscript based on your suggestion……………………………………….(Page 7,8)

4.3.3 Data collection and measurement(BP): the timing of BP measurement related to coffee consumption was revised as 1-2 hours (Study indicated that after caffeinated beverage intake blood pressure changes occur within 30 minutes, peak in 1-2 hours, and may persist for more than 4 hours) and reference also included ………………………………………................................................................... (Page 6)

___________________________________________________________________________________________

5. Result

5.1 Socio-demographic, Clinical and behavioral characteristics:

In this section we try to explain the findings based on the cross-tabulation analysis results but as mentioned in your review

• In which 29.4%, 34.0%, 47.1% and 52.4% participants had chronic diabetes complication respectively”

• In which 42.7%, 10.0% and 13.0% had chronic diabetes complication respectively.

• In which 6.0%, 32.2%, 19.7% and 6.6% participants had at least one chronic diabetes complication respectively.

Those are findings of overall chronic diabetes complication in terms of socio-demographic, clinical and behavioral characteristics in the cross-tabulation analysis result (Table 1,2) but we observed such way of explanation may result in confusion for the reader, so to make it clear and simple we prefer to omit/ remove all cross-tabulation findings of chronic diabetes complication from the text explanation of socio-demographic, clinical and behavioral characteristics section but readers can get those findings from the Table 1 & 2 …………………………………………………………………………………...(Page8-11)

5.2 Tables: all the abbreviations related to each table were placed in the footnote…… (Page 9,10,11,13)

6. Discussion: Except English language Proofreading, revision was not done in this section because you mentioned as “The discussion is well written”

7. Conclusion: Revision was not done because you stated as “It highlights the main findings and supported by the study results”

8. Reference: Reference 10: was replaced with updated reference, Reference 22: was replaced with updated reference. Accordingly all references were updated as per your suggestion ………(Page 18-21)

_______________________________________________________________________________________________

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PLoS One. doi: 10.1371/journal.pone.0290240.r004

Decision Letter 1

Manal S Fawzy

16 May 2023

PONE-D-22-12568R1Magnitude of chronic diabetes complications and its associated factors among diabetic patients attending the general hospitals in Tigray region, Northern EthiopiaPLOS ONE

Dear Dr. Berhe,

Please submit your revised manuscript by Jun 30 2023 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

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An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

We look forward to receiving your revised manuscript.

Kind regards,

Manal S. Fawzy, Ph.D., M.D.

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #2: All comments have been addressed

Reviewer #3: All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

Reviewer #2: Yes

Reviewer #3: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #2: Yes

Reviewer #3: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

Reviewer #2: Yes

Reviewer #3: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

Reviewer #2: No

Reviewer #3: Yes

**********

6. Review Comments to the Author

Reviewer #2: First, the manuscript looks much better than the first version, thanks for the authors.

Although, I do not think it is ready for publication.

The most important is to revise the enligh language again, and the author should submit an offcial proofreading certifcate for the manuscript, if the Editorial Board advise on this regard, it will be very helpful. As I still see lot of English and Grammer mistakes, and the writing way is not quite professional.

1. The abstarct/conclusion:

Conclusion: In this study, the magnitude of chronic diabetes complication was higher because more than half

of the study participants had at least one complication.

I donot understand this statement, the magitude is high than...what?

Also, revise the conculsion

2. The exclusion and inclusion criteria:

The author put bothe the criteria togther, which is confusing. Please specifiy what are the inclusion criteria? and what are the eclusion criteria?

3. Diagnosis of chronic diabetes complication:

3.1. I suggest using this statment in stead of yours

Coronary artery disease (CAD): The diagnosis criteria for CAD were either a patient with typical anginal pai or equivalent

symptoms and an abnormal resting ECG or an asymptomatic patient with abnormal stress test, either by

ECG or echo or a nuclear perfusion imaging test .

3.2. Peripheral vascuar disease:

The peripheral vascular disease defintion, it is advised to limit the ABI to less than 0.9 only, and delete more than 1.3

3.3. Neuropathy

loss of sensitivity is mis nomer, replace with hyposthesia or anasthesia in lower and upper limbs

spelling: limp ---> limb.

4. Tables:

4.1. Yes column: yes is wrongly written. Plz, correct.

4.2: The abbreveiations shoud be consistent: if you use SBP for systolic blood pressure, you have to use DBP for diastolic blood pressue, plz be consistent along the whole manuscript

Reviewer #3: I thank the authors to conduct this interesting study at the local setting.

All comments have addressed. No further comment required.

**********

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Reviewer #2: Yes: Hussein M Ismail

Reviewer #3: Yes: Mohammed Abdu Seid

**********

PLoS One. 2023 Aug 25;18(8):e0290240. doi: 10.1371/journal.pone.0290240.r005

Author response to Decision Letter 1

17 Jun 2023

RESPONSE TO REVIEWERS

Response to Reviewer #2

1. Abstract

1.1 Conclusion: revision was made based on your comment and it is revised as “In this study, more than half participants had at least one chronic diabetes complication”…………………………………....(Page 2)

2. Method

2.1 The exclusion and inclusion criteria: the inclusion criteria and exclusion criteria are separately written under eligibility criteria to avoid confusion………………………………………………………...(Page5)

2.2 Diagnosis of chronic diabetes complication

2.2.1 Coronary artery disease (CAD): corrected as per your suggestion……………………….......(Page 7

2.2.2 Peripheral Vascular disease: as per your suggestion the more than 1.3 (>1.3) was deleted from the definition, ABI to less than 0.9 only is used ………………………………………………………..(Page7)

2.2.3 Neuropathy: misnomer of loss of sensitivity in the definition replaced with “ hyposthesia or anesthesia” in lower and upper limbs & the work limp is corrected as limb……………………...(Page7)

3. Results

3.1 The wrongly written the word yes in the column is corrected throughout the tables………(Page 9,10,12 )

3.2 All abbreviations (SBP, DBP) were written consistently throughout the document ………...(Page 10-17)

4. Conclusion: corrected as “In this study, more than half participants had at least one chronic diabetes complication”…………………………………………………………………………………….........(Page15)

5. Language editing: Our Manuscript was copyedit for language usage, spelling, and grammar by Zainabu Karim Mohamed from MUHAS, Tanzania (email: zainab.karim4@gmail.com) and Prof. Lilian T. Mselle (email: nakutz@yahoo.com ) from MUHAS, Tanzania. Uploaded as Supporting Information file 1 ……………………………………………………………………………………………………….(all page)

Attachment

Submitted filename: Response to reviewers.docx

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PLoS One. doi: 10.1371/journal.pone.0290240.r006

Decision Letter 2

Manal S Fawzy

7 Aug 2023

Magnitude of chronic diabetes complications and its associated factors among diabetic patients attending the general hospitals in Tigray region, Northern Ethiopia

PONE-D-22-12568R2

Dear Dr. Berhe,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org.

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Kind regards,

Manal S. Fawzy, Ph.D., M.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

The authors have adequately addressed the concerns raised by the reviewers. Thank you

Reviewers' comments:

PLoS One. doi: 10.1371/journal.pone.0290240.r007

Acceptance letter

Manal S Fawzy

17 Aug 2023

PONE-D-22-12568R2

The magnitude of chronic diabetes complications and its associated factors among diabetic patients attending the general hospitals in Tigray region, Northern Ethiopia

Dear Dr. Berhe:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

If we can help with anything else, please email us at plosone@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Professor Manal S. Fawzy

Academic Editor

PLOS ONE

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

S1 Data set

(SAV)

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Data Availability Statement

All relevant data are within the paper and its Supporting Information files.

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The magnitude of chronic diabetes complications and its associated factors among diabetic patients attending the general hospitals in Tigray region, Northern Ethiopia

Kalayou K Berhe

Lilian T Mselle

Haftu B Gebru

Roles

Abstract

Background

Methods

Results

Conclusion

Background

Method and materials

Study design, setting and period

Population

Eligibility

Inclusion criteria

Exclusion criteria

Sample Size determination

Fig 1. Schematic presentation of the sampling procedure for a study on magnitude of chronic diabetes complication among diabetic patients attending the general hospitals in Tigray region, Northern Ethiopia, 2019/2020.

Sampling procedure

Data collection tool and measurement

Data collection procedure

Data management and analysis

Variables of the study

Independent variable

Dependent variable

Operational definition

Diagnosis of chronic diabetes complication

Ethical considerations

Results

Socio-demographic characteristics of the participant

Table 1. Socio-demographic characteristics by chronic diabetes complication among diabetic patients attending the general hospitals in Tigray region, Northern Ethiopian, 2019/2020 (N = 1,158).

Clinical and behavioural characteristics of the participants

Table 2. Clinical and behavioural characteristics by chronic diabetes complication among diabetic patients attending the general hospitals in Tigray region, Northern Ethiopian, 2019/2020 (N = 1,158).

The magnitude of chronic diabetes complication

Macrovascular complication

Fig 2. Magnitude of macrovascular complications among diabetic patients attending the general hospitals in Tigray region, Northern Ethiopian, 2019/2020.

Microvascular complication

Fig 3. Magnitude of microvascular complications among diabetic patients attending the general hospitals in Tigray region, Northern Ethiopian, 2019/2020.

Factor associated with chronic diabetes complication among patients with type 2 diabetes (T2D)

Table 3. Factors associated with chronic diabetes complication among diabetic patients attending the general hospitals in Tigray region, Northern Ethiopian, 2019/2020 (N = 1,158).

Discussion

Conclusion

Supporting information

Acknowledgments

Abbreviations

Data Availability

Funding Statement

References

Author response to previous submission

Decision Letter 0

Manal S Fawzy

Roles

Author response to Decision Letter 0

Decision Letter 1

Manal S Fawzy

Roles

Author response to Decision Letter 1

Decision Letter 2

Manal S Fawzy

Roles

Acceptance letter

Manal S Fawzy

Roles

Associated Data

Supplementary Materials

Data Availability Statement

ACTIONS

PERMALINK

RESOURCES

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