Zhao.
| Study characteristics | ||
| Methods |
Study design: parallel‐group RCT Unit of randomization and analysis: individual Number randomized:
Sample size calculation: not reported |
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| Participants |
Country: China Study period: enrollment August to December 2008; follow‐up to December 2017 Type of diabetes: type 2 Participants' baseline status:
Equivalence of groups at baseline: well balanced Inclusion criteria: 1) patients with T2DM diagnostic criteria as established by the WHO; 2) > 30 years of age when diagnosed, residents of the community; 3) 30 to 80 years old; 4) signed informed consent Exclusion criteria: 1) residential mobility, difficult to be regular follow‐up; 2) severe movement disorder; 3) poor compliance; 4) long‐term oral corticosteroids; 5) 2.5 times greater than normal ALT; 6) serum creatinine greater than 200 μmol/L; 7) moderate and severe schizophrenia; 8) those who are participating in other clinical trials; 9) those who are considered by the doctors as inappropriate to participate |
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| Interventions |
Intervention 1: intensive monitoring: examined every month; glycated hemoglobin re‐examined every 3 months Intervention 2: standard group: followed every 2 months; glycated hemoglobin re‐examined every 6 months Target control, per guidelines: " ... defined as HbA1c < 7.0 mmol/L, systolic blood pressure (SBP) < 130 mm Hg, diastolic blood pressure (DPB) < 80 mm Hg, and low‐density lipoprotein cholesterol (LDL‐C), 2.6 mmol/L ...". However, BP target stated to have been < 140/90 mmHg (Discussion). Different for intensive and standard groups? Length of follow‐up:
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| Outcomes |
Primary outcome, as specified for this review: incidence of diabetic retinopathy Secondary outcome, as specified for this review: "diabetic retinopathy (fundus photocoagulation and vitrectomy", i.e. PDR Other diabetic retinopathy outcomes: none Retinopathy diagnosis and monitoring: "The patients were examined once a year, including ... fundus examination ... . Microvascular complications include ... diabetic retinopathy (fundus photocoagulation and vitrectomy). The photographs were uploaded to the data center and checked." Intervals at which outcomes were assessed: every 1 or 2 months; glycated hemoglobin was re‐examined every 3 or 6 months, for intensive and standard groups respectively. Frequency of fundus photography or examinations not mentioned: "photographs were uploaded to the data center and checked". Participants (eyes) examined for the outcome: 168: intensive 92, standard 76 Cost of interventions: not reported Quality of life: not reported ("benefit of quality of life") Adverse effects outcomes: "As far as death caused by cardiovascular events, cerebrovascular events, and newly onset coronary heart disease are concerned, there were no significant differences on the aforementioned endpoint events between the two groups based on target control achieved more than 3 times or not. There was less incidence of new onset cerebrovascular events, stenosis or occlusion of large arteries, and diabetic microvascular complications in patients who achieved target control (HbA1c and LDL‐C) and the joint target control more than 3 times than those less than 3 times" Other outcomes: MI, stroke, CHD, nephropath, CVD/TIA, CABG, peripheral vascular disease, angina, hospitalization for various events; diabetic foot, amputation |
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| Notes |
Source of funding: Special Scientific Research on Capital Health Development, Beijing Municipal Science & Technology Commission, and International Diabetes Federation Declaration of interest: reported no conflict of interest Run‐in length: not applicable Class(es) of antihypertensive agents assigned: not applicable Degrees of blood pressure control achieved, mean SBP/DBP: intensive: 127.0 (9.9)/71.5 (7.9) mmHg; standard: 127.8 (11.3)/71.0 (7.4) mmHg; "there was no statistical difference in the control of blood pressure between groups ... " Trial registration: registered with ChiCTR‐TRC13003978 and ChiCTR‐OOC‐15006090 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Multistage random sampling approach (completed by the statistical expert) |
| Allocation concealment (selection bias) | Unclear risk | Treatment allocation concealment not reported. |
| Masking (performance bias and detection bias) Primary outcomes | Unclear risk | No mention of masking |
| Incomplete outcome data (attrition bias) Primary outcome | High risk | Outcomes reported for 81.4% (86.8% of survivors) of intensive group and 68.5% (78.4% of survivors) of standard group. |
| Incomplete outcome data (attrition bias) Secondary outcomes | High risk | Outcomes reported for 81.4% (86.8% of survivors) of intensive group and 68.5% (78.4% of survivors) of standard group. |
| Selective reporting (reporting bias) | Low risk | Outcomes specified in trial registry were reported in study. |
| Other bias | Low risk | None identified. |
Note: we sought information from all reports from each individual study whenever an included trial was reported in more than one publication, technical report, protocol, or registry record.
Abbreviations:
AAO, American Academy of Ophthalmology ABCD (1), Appropriate Blood Pressure Control in Diabetes (3 RCTs) ACCORD Eye, Action to Control Cardiovascular Risk in Diabetes ‐ Eye Study ACEi, angiotensin‐converting enzyme inhibitors ACR, albumin to creatinine ratio AdDIT, Adolescent type 1 Diabetes cardio‐renal Intervention Trial ADDITION‐Europe, Anglo‐Danish‐Dutch Study of Intensive Treatment in People with Screen‐Detected Diabetes in Primary Care ADVANCE/AdRem, Action in Diabetes and Vascular Disease Retinal Measurements Study ALT, alanine transaminase ARB, angiotensin receptor blocker BCVA, best‐corrected visual acuity BENEDICT, BErgamo NEphrologic DIabetes Complications Trial BMI, body mass index, kg/m2 BP, blood pressure, usually expressed as SBP/DBP, each in mmHg C‐peptide, connecting peptide CABG, coronary artery bypass graft surgery CCB, calcium channel blocker CHD, coronary heart disease CHF, congestive heart failure CI, confidence interval CSME, clinically significant macular edema CTRC at Harbor‐UCLA Medical Center, Clinical and Translational Research Center at Harbor‐University of California, Los Angeles Medical Center CV, cardiovascular CVD, cardiovascular disease CWS, cotton‐wool spots DBP, diastolic blood pressure DCCT, Diabetes Control and Complications Trial DEMAND, Delapril and Manidipine for Nephroprotection in Diabetes DIRECT Prevent 1, 1 of 3 Diabetic Retinopathy Candesartan Trials Programme RCTs: Prevent 1, Protect 1, Protect 2 DM, diabetes mellitus DME, diabetic macular edema DR, diabetic retinopathy ETDRS, Early Treatment Diabetic Retinopathy Study EUCLID, EURODIAB Controlled Trial of Lisinopril in Insulin‐Dependent Diabetes Mellitus study EURODIAB, European Diabetes GAD, glutamic acid decarboxylase GFR, glomerular filtration rate HbA1c, glycated hemoglobin HDL, high‐density lipoprotein HR, hazard ratio IDDM, insulin‐dependent diabetes mellitus IHD, ischemic heart disease IMT, intima‐media thickness IQR, interquartile range IRMA, intraretinal microvascular abnormalities LDL, low‐density lipoprotein LDL‐C, low‐density lipoprotein cholesterol LTBP, less tight blood pressure logMAR, logarithm of the minimum angle of resolution of an eye ME, macular edema Medi‐Cal, California Medi‐Cal Type 2 Diabetes Study MI, myocardial infarction ndCCBs, non‐dihydropyridine calcium channel blockers NEJM, New England Journal of Medicine NIDDK, National Institute of Diabetes and Digestive and Kidney Diseases, US National Institutes of Health NPDR, non‐proliferative diabetic retinopathy NPH, Neutral Protamine Hagedorn NV, neovascularization OCT, optical coherence tomography OFU, observational follow‐up OR, odds ratio p‐creatinine, plasma creatinine PDR, proliferative diabetic retinopathy PTCA, percutaneous transluminal coronary angioplasty PVD, peripheral vascular disease RAS, renin‐angiotensin system RASS, Renin‐Angiotensin System Study RCT, randomized controlled trial RD, retinal detachment ROADMAP, Randomized Olmesartan and Diabetes Microalbuminuria Prevention SBP, systolic blood pressure SD, standard deviation SR, sustained release Steno‐2, Steno type 2 randomised study T2DM, type 2 diabetes mellitus TBP, tight blood pressure TIA, transient ischemic attack UAE, urinary albumin excretion UKPDS/HDS, United Kingdom Prospective Diabetes Study/Hypertension in Diabetes Study UTI, urinary tract infection VA, visual acuity WESDR, Wisconsin Epidemiologic Study of Diabetic Retinopathy WHO, World Health Organization