Abstract
To assess the association between insulin regimens and health-related quality of life (HRQoL) after the introduction of basal insulin (BI) among people with type 2 diabetes in real-world clinical settings. 16,339 registered people with diabetes who had inadequate glycaemic control by oral agents initiated BI (either single BI or Basal-bolus) and completed a 6-month follow-up from 209 hospitals were included in the analyses. At the end of the follow-up, the switches of insulin regimens, change of HRQoL (EQ-5D-3L) and their associations were assessed. Initial insulin regimens of single BI and of basal-bolus (BI included Glargine, Detemir, and Neutral Protamine Hagedorn) accounted for 75.6% and 24.4%, respectively. At 6 months, regimens used were BI alone (65.2%), basal-bolus (10.4%), and premixed (6.4%), whereas 17.9% stopped all insulin therapy. The visual analogue scale score increased by 5.46 (P < .001), and the index value increased slightly by 0.02 (P < .001). Univariate analysis showed that people with diabetes taking basal-bolus regimen had the greatest improvement on HRQoL in all dimensions, especially in the reduction of the percentage of Pain/Discomfort (by 10.03%) and Anxiety/Depression (by 11.21%). In multivariable analysis, single BI or premixed insulin at 6 months was associated with more improvement of visual analogue scale score compared with stopping all insulin. Improved HRQoL was observed after initiating BI in people with type 2 diabetes . If the same achievement on HbA1c control can be guaranteed, single BI is preferred to other regimens from the viewpoint of HRQoL. Basal-bolus has the most significant potential to increase HRQoL, however, the people with diabetes characteristics differ from those initiating BI alone. Further longitudinal cohort study with a longer study period might be necessary to evaluate the certain effect.
Keywords: basal insulin, quality of life, type 2 diabetes
1. Introduction
Diabetes imposes heavy burdens on individuals, their families, and healthcare systems. The natural progression of underlying loss of islet B-cell function usually necessitates timely insulin treatment. Current evidence-based guidelines on diabetes management recommend that initiating insulin treatment should be considered a second or third-line treatment when individualized glucose control targets cannot be achieved by lifestyle modification and maximum doses of oral antihyperglycemic agents (OAAs).[1–5] Adding basal insulin (BI) to existing OAAs is recommended as the initial step of insulin therapy for its advantages of better glycemic control with less insulin dose and weight gain and fewer hypoglycemic events.[1]
Insulin therapy can have positive[2–4] and negative[5–7] impacts on the health-related quality of life (HRQoL) in people with diabetes. It generally provides better glycemic control and improves HRQoL by reducing diabetic complications,[8–10] but it can also be inconvenient, painful and burdensome, restricting daily activities in people with diabetes.[11] Furthermore, insulin treatment entails the risk of hypoglycemic episodes that detracts from HRQoL both in terms of health and because of fear of such an episode in people with diabetes. Although there is no compelling evidence that initiating insulin therapy compromises the quality of life,[10] switching to insulin therapy is often delayed[12,13] because of such concerns.
Since BI is mainly recommended as the first step of insulin treatment, its impact on HRQoL will affect the short-term and long-term well-being in people with diabetes, which also influences a person’s long-term acceptance of BI and other insulin treatment plans. Studies indicate a high rate of discontinuation by people with diabetes of BI within several months of its prescription.[14] Understanding the impacts of insulin regimens on HRQoL may guide efforts to improve the acceptance of this therapy and, hence, their adherence to the treatment in people with diabetes.
Previous RCTs[3,4] or observational studies in primary care practice[15,16] or routine clinical practice[17] have evaluated the impact of starting a specific BI (glargine or detemir) treatment on HRQoL of people with Type 2 diabetes (T2DM). However, these studies do not examine the following change in insulin treatment regimens and its impact on quality of life in real-world practice.
Based on the 6-month, prospective Observational Registry of Basal Insulin Treatment (ORBIT) study, we aim to assess how the HRQoL was changed after initiating BI therapy, especially after 6 months when the insulin therapy regimens also changed in real-world settings.
2. Materials and methods
2.1. Study design
ORBIT is a 6-month multi-center, observational, prospective study. People with diabetes were enrolled in secondary or tertiary hospitals in all 8 geographic regions of China from December 2011 to June 2013. Those participants with T2DM aged 18 to 80 years and inadequately controlled on OAAs (HbA1c ≥ 7%, 53 mmol/mol) and willing to accept BI treatment were consecutively enrolled by their physicians. The participants were then given a face-to-face interview (baseline-v1) and at the end of the study (6 months-v3) and by telephone in the middle of the study (3 months-v2). The demographic and clinical characteristics of each people with diabetes were collected initially, along with information on their medication and treatment, their diet, including fruit consumption, physical activity, self-monitoring of blood glucose, hypoglycemia episodes, body weight, HbA1c and fasting plasma glucose (FPG) levels, and also, their HRQoL.
Other than the introduction of BI and the instruction in its use, no participar clinical or supportive intervention was given to the participants in this study. At v1, basal insulin had been prescribed with or without prandial insulin at the physicians’ discretion and considering the preferences of each people with diabetes. Previously used OAAs before introducing BI were adjusted as needed when BI therapy was added again according to physicians’ discretion and the preference of people with diabetes. During follow-up, there was no limitation on the kind of OAAs or insulin that could be prescribed. Titrations of insulin doses and medication regimen changes were all performed according to the provider’s recommendation and the preference of people with diabetes.
The protocol was approved by the Institutional Review Board (IRB) of Peking University (no. IRB00001052-11070), when necessary, local IRBs. All participants were provided with written informed consent. Details of the study design are included in a paper reporting the baseline results.[18]
2.2. HRQoL measurement
The HRQoL was measured by the Chinese version of the EQ-5D-3L instrument obtained from the EuroQol Group[19] at baseline and after 6 months of therapy. The validity and reliability of the Chinese version have been assessed in the Chinese mainland.[20,21] The EQ-5D-3L consists of 2 sections – the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The former comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each item, respondents indicated one of 3 levels of severity: no problems, some or moderate problems, or extreme problems. The response from people with diabetes to these 5 dimensions were converted into a single summary index (scale, −0.15 to 1.0) by Chinese utility values for EQ-5D-3L health states.[22] The latter recorded how respondents viewed their HRQoL, on a scale of (0–100) with higher scores indicating a greater sense of well-being and quality of life.
2.3. Statistical analysis
A total of 16,339 people with diabetes who completed the follow-up at v3 were included in statistical analyses. Characteristics at both v1 and v3 were analyzed descriptively by insulin regimens used at v3, which consisted of BI alone, basal-bolus, premixed and stopping all insulin. Dichotomous and polychotomous variables were analyzed using the number and percentage of people with diabetes. Continuous variables were analyzed using means and standard deviations or medians and quartile ranges for skewed distribution.
EQ-5D-3L levels of each were dichotomized into “no problems” (i.e. level 1) and “problems” (i.e. levels 2 and 3). Percentages of reported problems for each dimension at both v1 and v3 were showed by different insulin regimens at v3. Changes in percentages of reported problems were calculated by the differences between the percentages of v1 and v3. Chi-square tests were used to evaluate the difference of changes among different insulin regimens in each dimension. Two-sided tests with a P value < .05 were considered statistical significance.
Changes in HRQoL (defined by EQ-5D-3L index value and EQ-5D-3L VAS score) were analyzed by their differences between v1 and v3. Analyses of variance were used to evaluate the difference of their changes among 4 insulin regimens with a P value < .05 considered statistical significance.
The exposure variables are the baseline use of different insulin treatments, and their changes during the 6 months of follow-up. The primary outcome variable is EQ VAS, and the secondary outcome variable is EQ-5D descriptive system, and Index value.
Further, stepwise multivariable linear regression was employed to explore factors associated with changes in EQ-5D-3L index value (multiplied by 100) and VAS score. Screening variables in the regression model included the baseline characteristics (gender, age, education degree, residence, duration of diabetes, Body Mass Index at baseline, Body Mass Index change, and number of diabetes-related complications) of people with diabetes, diabetes management/treatment factors at v1 and v3 (insulin regimen at v3, hypoglycemia status, frequency of self-monitoring of blood glucose at v3, changes in diet and physical activities, number of OAA types before and after initiating basal insulin) and clinical outcomes (HbA1c reduction) at v3. Because of the documented association between diabetes complications and a decrease in QoL,[23] EQ-5D VAS score at baseline was not introduced into the multivariable analysis to avoid overlooking important determinants such as the number of complications, which are more critical in determining the clinical use of BI therapy, rather than the baseline VAS score. Statistical analyses were performed using SAS (Version 9.4; SAS Institute Inc., SAS Campus Drive, Cary, NC).
3. Results
3.1. Demographic characteristics
Over a period of 1.5 years, 18,995 people with diabetes were recruited from 209 hospitals (104 secondary and 105 tertiary) at v1. The baseline characteristics of participants have been described in a separate publication.[18] A total of 16,339 people with diabetes were included in this study as they had completed a 6-month follow-up into their health after initiating BI. The demographic and clinical characteristics at v1 or/and v3 were listed in Table 1. At baseline, 3983 (24.4%) people were prescribed with basal-bolus regimen, while that percentage dropped to 1705 (10.4%) after a 6-month follow-up. At the 6-month follow-up, 1053 (6.4%) people switched to premixed insulin and 2928(17.9) stopped insulin treatment (Table 1).
Table 1.
Description of baseline population characteristics and changes in 6-month follow-up (N = 16339).
| Variables | Baseline | 6 month |
|---|---|---|
| Age (yr), mean (SD) | 55.4 (10.3) | |
| Male, n (%) | 8623 (52.8) | |
| Residence from rural area, n (%) | 5165 (31.6) | |
| With senior middle or higher education, n (%) | 6991 (42.8) | |
| Duration of diabetes (yr), median (QR) | 6.5 (5.3) | |
| Number of self-reported complications, n (%) | ||
| 0 | 10382 (63.5) | |
| 1 | 3465 (21.2) | |
| ≥2 | 2492 (15.3) | |
| Type of BI, n (%) | ||
| Glargine | 11289 (69.1) | 8902 (54.5) |
| Detemir | 2135 (13.1) | 1585 (9.7) |
| NPH | 2915 (17.8) | 1871 (11.5) |
| Insulin regimen, n (%) | ||
| BI only | 12356 (75.6) | 10653 (65.2) |
| Basal-bolus | 3983 (24.4) | 1705 (10.4) |
| Premixed | 1053 (6.4) | |
| Stop all insulin | 2928 (17.9) | |
| Number of OAA being used, n (%) | ||
| 0 | 3269 (20.0) | 2809 (17.2) |
| 1 | 7045 (43.1) | 7064 (43.2) |
| 2 | 4984 (30.5) | 5424 (33.2) |
| 3 | 1041 (6.4) | 1037 (6.4) |
| Hypoglycaemia events in the past 1 month (YES), n (%) | 903 (5.5) | 1473 (9.0) |
| HbA1c (%), mean (SD) | 9.6 (2.0) | 7.4 (1.4) |
| BMI (kg/m2), mean (SD) | 24.7 (3.4) | 24.8 (3.2) |
| SMBG in last month (times/mo) | 5.2 (10.0) | 6.3 (7.9) |
| Daily food intake (g), mean (SD) | ||
| Staple | 310.4 (104.0) | 292.6 (87.2) |
| Vegetable | 328.4 (137.0) | 344.2 (127.8) |
| Fruit | 72.8 (85.5) | 79.7 (73.4) |
| Meat | 99.9 (66.2) | 91.6 (56.8) |
| Physical activity (d/wk), mean (SD) | ||
| With ≥ 30 minutes physical activity | 5.4 (2.5) | 5.9 (2.1) |
| Participating in an extra exercise | 3.2 (3.1) | 4.0 (2.9) |
BI = basal insulin, BMI = body mass index, NPH = Neutral Protamine Hagedorn, OAA = oral antihyperglycemic agent, QR = quartile range, SD = standard deviation, SMBG = self-monitoring of blood glucose.
HRQoL improvement among people with diabetes receiving different insulin regimens
Table 2 displayed VAS score of EQ-5D-3L, the percentages of reported problems for 5 dimensions, the index value, and their changes from v1 to v3, grouped by insulin regimen groups at v3.
Table 2.
Changes on health related quality of life (EQ-5D-3L) during follow-up among patients by insulin regimen groups at 6-month (N = 16339).
| Dimensions and values | Insulin regimen at 6-mo | Baseline | 6-mo | Change |
|---|---|---|---|---|
| VAS, mean (SD) | Total | 76.57 (12.35) | 82.02 (10.12) | 5.46 (10.99) |
| BI only | 76.74 (12.06) | 82.35 (10.01) | 5.61 (10.69)** | |
| Basal-bolus | 76.05 (12.37) | 81.65 (9.76) | 5.60 (10.31) | |
| Premixed | 75.15 (13.66) | 81.02 (10.32) | 5.87 (12.29) | |
| Stop all insulin | 76.74 (12.86) | 81.41 (10.56) | 4.67 (11.90) | |
| Percentage of patients reporting any problem on dimensions of | ||||
| Mobility | Total | 4.31 | 3.01 | −1.30 |
| BI only | 3.91 | 2.69 | −1.22** | |
| Basal-bolus | 6.45 | 4.75 | −1.70 | |
| Premixed | 4.65 | 3.80 | −0.85 | |
| Stop all insulin | 4.41 | 2.87 | −1.54 | |
| Self-care | Total | 1.40 | 1.23 | −0.17 |
| BI only | 1.25 | 1.15 | −0.10** | |
| Basal-bolus | 2.82 | 2.05 | −0.77 | |
| Premixed | 1.52 | 1.33 | −0.19 | |
| Stop all insulin | 1.06 | 1.02 | −0.04 | |
| Usual activities | Total | 3.21 | 2.44 | −0.77 |
| BI only | 2.81 | 2.23 | −0.58** | |
| Basal-bolus | 6.10 | 3.93 | −2.17 | |
| Premixed | 3.04 | 3.04 | −0.00 | |
| Stop all insulin | 3.07 | 2.12 | −0.95 | |
| Pain/discomfort | Total | 18.04 | 8.93 | −9.11 |
| BI only | 17.47 | 8.27 | −9.20* | |
| Basal-bolus | 17.89 | 7.86 | −10.03 | |
| Premixed | 22.60 | 14.25 | −8.35 | |
| Stop all insulin | 18.55 | 10.04 | −8.51 | |
| Anxiety/depression | Total | 14.92 | 6.46 | −8.46 |
| BI only | 14.38 | 6.59 | −7.79* | |
| Basal-bolus | 16.66 | 5.45 | −11.21 | |
| Premixed | 18.61 | 8.93 | −9.68 | |
| Stop all insulin | 14.52 | 5.67 | −8.85 | |
| Index value, mean (SD) | Total | 0.95 (0.10) | 0.97 (0.08) | 0.02 (0.09) |
| BI only | 0.95 (0.10) | 0.98 (0.08) | 0.02 (0.08) | |
| Basal-bolus | 0.94 (0.12) | 0.97 (0.09) | 0.03 (0.10) | |
| Premixed | 0.94 (0.10) | 0.96 (0.09) | 0.03 (0.09) | |
| Stop all insulin | 0.95 (0.10) | 0.97 (0.08) | 0.02 (0.09) | |
BI = basal insulin, VAS = visual analogue scale.
P < .05.
P < .001 when comparing the change among patients with different insulin regimen at 6-month.
At baseline, the percentages of people with diabetes reporting problems in pain/discomfort (18%) and anxiety/depression (14.9%) were much higher than those reporting problems in mobility (4.3%), self-care (1.4%) and usual activities (3.2%). Those percentages in 5 dimensions were all reduced, with higher reductions in pain/discomfort (−9.1%) and anxiety/depression (−8.5%) compared with other 3 dimensions (from −0.77% to −1.3%). VAS score increased by 5.46 (from 76.57 to 82.02) (P < .001), and EQ-5D index score increased slightly by 0.02 (from 0.95 to 0.97) although statistically significant (P < .001) from v1 to v3. Moreover, HRQoL-related percentages of reporting problems, index value and VAS score were all improved in each insulin regimen at v3 and those who initiated BI at v1 but stopped all insulin at v3. Reductions of reporting problems in 5 dimensions significantly differed among 4 insulin subgroups at v3 (P < .05 in pain/discomfort and anxiety/depression; P < .001 in mobility, self-care and usual activities). People with diabetes on basal-bolus had the highest reductions of percentages of reporting problems in all the 5 dimensions even though their baseline percentages were not always the highest among 4 groups, such as those in the dimension of pain/discomfort (17.9% vs 17.5%, 22.6%, 18.6%) and anxiety/depression (16.7% vs 14.9%, 14.4%, 18.6%).
3.2. Effect of insulin regimens on HRQoL in multivariable analysis
After controlling for potential confounders (i.e., number of complications, HbA1c reduction, diet and physical activities), multivariable analyses showed that insulin regimens of BI only and premixed at v3 were associated with increased VAS score compared with stopping all insulin therapy, whereas this association was not significant for index value (Table 3). Moreover, improvements in VAS score and index value were both associated with more diabetes complications at v1, more increased consumption of vegetables, and more increased general and extra physical activities from v1 to v3. Other factors associated with increased VAS score were HbA1c reduction, decreased consumption of staple food and increased fruit consumption, whereas those associated with increased index value were female people with diabetes and ever experiencing minor hypoglycemia in the last month at baseline.
Table 3.
Predictors of improved health related quality of life assessed by EQ-5D-3L VAS and index value – results of stepwise multivariable linear regression.*
| Predictors | Estimate (β) | SE | P value |
|---|---|---|---|
| Predictors of VAS improvement (v3–v1) | |||
| Insulin regimen at v3 (vs stop all insulin) | |||
| BI only | 1.0265 | 0.2280 | <.001 |
| Premixed | 0.8961 | 0.3929 | .023 |
| Basal-bolus | 0.2767 | 0.3365 | .411 |
| Predictors of index value (v3–v1) | |||
| Insulin regimen at v3 (vs stop insulin) | |||
| BI only | −0.1127 | 0.1826 | .537 |
| Basal-bolus | 0.0716 | 0.2681 | .789 |
| Premixed | −0.5187 | 0.3148 | .099 |
BI = basal insulin, BMI = body mass index, OAAs = oral antihyperglycemic agents, SMBG = self-monitoring of blood glucose, VAS = visual analogue scale.
Variables removed during the stepwise regression included gender, age, education degree, duration of diabetes, BMI at baseline, BMI change, hypoglycemia status at v1 and v3, frequency of SMBG at v3, number of OAA types before and after initiating basal insulin, and meat consumption. Confounders controlled included number of complications, HbA1c reduction, diet and physical activities.
4. Discussion
This study of HRQoL, measured by the EQ-5D-3L instrument, was carried out among people with T2DM initiating BI therapies in the real world. Although the introduction of insulin would complicate the treatment, we found that after starting BI therapies, people with T2DM experienced significantly increased overall HRQoL in terms of reducing reported problems for 5 dimensions and the increase of index value and VAS score. Moreover, in 5 dimensions, pain/discomfort and anxiety/depression were improved more significantly compared with other 3 dimensions. People with diabetes on basal-bolus were more advantageous to reducing reporting problems in all 5 dimensions compared with other insulin regimens. In multivariable regression analysis, compared with cessation of all insulin therapy, regimens of BI or premixed were associated with greater VAS score improvement, while adding bolus insulin to BI showed no significant improvement of VAS score. Other associated factors were rural residence, more diabetes-related complications at baseline, higher HbA1c reduction, decreased staple food consumption, and increased fruit/vegetable consumption and physical activities.
These results indicate that the experience of these people with diabetes in starting BI therapies appears to have been positive. Similar results have been seen in several RCTs,[3,4] which examined the effect of the addition of insulin on HRQoL and observational studies,[15–17,24] which explored the association between the use of basal insulin (glargine or detemir) and improvement of HRQoL. However, ORBIT was an observational study to assess the unconstrained introduction of basal insulin in real-world clinical settings and had no control group. Therefore, it was hard to distinguish the HRQoL improvement attributable to the initiation of BI regimen from other confounding factors such as improvement of other lifestyles, social and family support and concomitant OAAs. Nevertheless, a significant association between different regimens of insulin therapies and HRQoL was observed in our study.
Basal-bolus therapy might be adopted by people with diabetes with a much higher level of HbA1c, who, therefore, experienced a greater reduction in HbA1c, which might be associated with greater improvements in problems on 5 dimensions compared with people with diabetes on other insulin regimens. This result suggested that a higher HbA1c reduction would contribute to a greater HRQoL improvement, supported by our multivariable analysis of the improvement in VAS score. Given its greater effect on reducing HbA1c which accompanies HRQoL benefit but without compromising it, a basal-bolus regimen might be suggested for those whose HbA1c target cannot be fulfilled with a single BI. Nevertheless, a time-trade-off study indicated that insulin treatment with a simple regimen with fewer injections and/or the need for less planning, and/or causes weight loss or less weight gain will positively impact HRQoL, compared with other treatments. Moreover, recent study showed that long-acting insulin analogs are associated with a decrease in required number of insulin injection and required insulin dosage for better diabetic control.[25] Therefore, BI alone therapy is preferred to other complicated injection regimens at initiation unless HbA1c target cannot be reached.
Multivariable regression analysis also showed that people with diabetes with more complications had lower HRQoL at baseline, as one would expect, but then more remarkable improvement in EQ-5D-3L VAS score after BI treatment. A recent published review showed treatment with long-acting insulin regimens may improve disease control in diabetic subjects with cardiac conditions.[26] A large primary care cohort study from USA also suggested that prevention of complications have the most significant potential to improve HRQoL in T2DM.[27] Thus, in addition to clinical benefits, improvements in quality of life may be considered in advocating insulin treatment for people with diabetes complications.
Positive lifestyle change including increased consumption of vegetable and fruit and increased physical activity was significantly associated with improvement of VAS score. At the same time, increases in consumption of “staples” (usually rice, steamed buns, bread and other foods high in carbohydrates and thus likely to raise blood sugar) were inversely associated with VAS score improvement. The Look AHEAD Trial supported that intensive lifestyle intervention for overweight/obese people with T2DM may reduce the risk of developing clinically significant symptoms of depression and preserve physical HRQoL.[28] The U.S. Behavioural Risk Factor Surveillance System in 2005 found that the accumulation of multiple healthy lifestyle habits (not smoking, engaging in adequate leisure time physical activity, and consuming 5 or more servings of fruits and vegetables per day) was significantly associated with better HRQoL among people with diabetes.[29] The low-carbohydrate diet also showed a positive effect on HRQoL improvement in previous studies.[30,31] These findings suggest that lifestyle interventions should be considered when considering antihyperglycemic therapy not only for its anti-diabetic effect but also for the contribution to the improved HRQoL.
The major strength is that ORBIT is the largest study known to focus on the changes of HRQoL after initiating BI in people with T2DM uncontrolled on OAAs in real-world clinical settings. Relative to most studies that evaluated the advantages of specific insulin (glargine or other insulin analogues) in limited populations, another strength is that this study distinguished by reflecting impacts of BI according to physicians’ choices of BI rather than research protocols and across broad, with representative samples drawn from practices in routine clinical settings.
There were 2 major limitations in this study. First, although EQ-5D-3L has been widely used in treatment evaluation for diabetes, disease-specific questionnaires are often regarded as more sensitive than generic measures such as EQ-5D-3L for capturing the impact of treatment.[10] As mentioned above, it is an observational study without control group and the 6-month follow-up period is short. Therefore, further longitudinal cohort study with a longer period might be necessary to evaluate the effect BI brought to the quality of life.
5. Conclusion
Improved quality of life was observed after initiating BI therapies in real-world clinical settings. Significant relief of anxiety and depression can serve as an important reason to persuade patients to initiate insulin therapy if OAAs fail. In addition, a healthier lifestyle, such as eating more vegetables and doing more physical activities, can help to control blood sugar and improve the quality of life at the same time. Basal-bolus treatment might have the most significant potential to increase HRQoL of people with diabetes, but if the same HbA1c control can be achievable for people with diabetes in the same situation, BI therapy is preferred to other treatments from the viewpoint of HRQoL.
Acknowledgments
The authors would like to thank the investigators and people with diabetes from the 209 study hospitals for their participation, without whom this study would not have been possible.
Author contributions
Conceptualization: Puhong Zhang, Yuqian Bao, Linong Ji, Xian Li, Weiping Jia.
Formal analysis: Heng Zhang, Dongshan Zhu, Xian Li, Jiaochao Ji.
Funding acquisition: Linong Ji, Weiping Jia.
Investigation: Puhong Zhang, Yuqian Bao, Fang Zhao.
Methodology: Puhong Zhang, Dongshan Zhu, Xian Li, Jiaochao Ji.
Project administration: Fang Zhao.
Writing – original draft: Puhong Zhang, Yuqian Bao, Heng Zhang, Dongshan Zhu.
Writing – review & editing: Minyuan Chen, Edwin B. Fisher, Yang Zhao, Nadila Duolikun, Du Wang.
Abbreviations:
- BI
- basal insulin
- HRQoL
- health-related quality of life
- IRB
- Institutional Review Board
- OAAs
- oral antihyperglycemic agents
- ORBIT
- Observational Registry of Basal Insulin Treatment
- QoL
- quality of life
- T2DM
- type 2 diabetes
- VAS
- visual analogue scale
PZ and YB contributed equally to the work.
This investigator sponsored study received funding from Sanofi.
The protocol was approved by the Institutional Review Board (IRB) of Peking University (no. IRB00001052-11070), and when necessary, local IRBs. All participants were provided with written informed consent.
The authors have no conflicts of interest to disclose.
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
How to cite this article: Zhang P, Bao Y, Chen M, Zhang H, Zhu D, Ji L, Li X, Ji J, Zhao F, Fisher EB, Zhao Y, Duolikun N, Wang D, Jia W. Changes of health-related quality of life after initiating basal insulin treatment among people with type 2 diabetes. Medicine 2023;102:34(e34718).
Contributor Information
Puhong Zhang, Email: zhang.heng@synyi.com.
Yuqian Bao, Email: byq522@163.com.
Minyuan Chen, Email: chen.minyuan@hotmail.com.
Heng Zhang, Email: zhang.heng@synyi.com.
Dongshan Zhu, Email: dongshan.zhu@uq.net.au.
Linong Ji, Email: jiachaoji@linkdoc.com.
Xian Li, Email: lxian@georgeinstitute.org.cn.
Jiachao Ji, Email: jiachaoji@linkdoc.com.
Fang Zhao, Email: wzhao@georgeinstitute.org.cn.
Edwin B. Fisher, Email: fishere@email.unc.edu.
Yang Zhao, Email: wzhao@georgeinstitute.org.cn.
Nadila Duolikun, Email: nadilapku@sina.com.
Du Wang, Email: dwang@georgeinstitute.org.cn.
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