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Determining the optimal fasting glucose target for patients with type 2 diabetes: Results of the multicentre, open-label, randomized-controlled FPG GOAL trial.

ABSTRACT: The optimal fasting blood glucose (FBG) target of achieving HbA1c less than 7.0% in type 2 diabetes (T2D) patients remains controversial. This open-label trial randomized (1:3:3) 947 adults with uncontrolled T2D (HbA1c >7% to ≤10.5%) who were using one to three oral antidiabetic drugs to achieve an FBG target of 3.9 < FBG ≤5.6 mmol/L (Group 1), 3.9 < FBG ≤6.1 mmol/L (Group 2) or of 3.9 < FBG ≤7.0 mmol/L (Group 3). Targets were achieved using a pre-defined insulin glargine 100 U/mL titration scheme. The primary endpoint was proportion of patients achieving HbA1c <7.0% at 24 weeks. At 24 weeks, 44.4%, 46.1% and 37.7% of patients achieved HbA1c <7.0% in Groups 1, 2 and 3, respectively (P = 0.017; Group 2 vs Group 3). Alert hypoglycaemia (glucose ≤3.9 mmol/L) was significantly more frequent in Group 1 than in Group 3 (38.9 vs 23.3%; P < 0.001) but was not in Group 2 vs Group 3 (27.5% vs 23.3%; P = 0.177). Clinically important hypoglycaemia (glucose ≤3.0 mmol/L) was reported in 4.8%, 2.0% and 3.8% of patients in Groups 1, 2 and 3, respectively. In conclusion, the optimal FBG target for most Chinese patients with T2D appears to be 3.9-6.1 mmol/L.

SUBMITTER: Yang W

PROVIDER: S-EPMC6772047 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Determining the optimal fasting glucose target for patients with type 2 diabetes: Results of the multicentre, open-label, randomized-controlled FPG GOAL trial.

Yang Wenying W Ma Jianhua J Yuan Guoyue G Li Ling L Zhang Min M Lu Yibing Y Ye Xinhua X Song Weihong W Liu Ming M Wu Jun J Chen Riqiu R Li Yunguang Y Zhang Xia X Cui Nan N Yang Jinkui J

Diabetes, obesity & metabolism 20190610 8

The optimal fasting blood glucose (FBG) target of achieving HbA1c less than 7.0% in type 2 diabetes (T2D) patients remains controversial. This open-label trial randomized (1:3:3) 947 adults with uncontrolled T2D (HbA1c >7% to ≤10.5%) who were using one to three oral antidiabetic drugs to achieve an FBG target of 3.9 < FBG ≤5.6 mmol/L (Group 1), 3.9 < FBG ≤6.1 mmol/L (Group 2) or of 3.9 < FBG ≤7.0 mmol/L (Group 3). Targets were achieved using a pre-defined insulin glargine 100 U/mL titration sche ...[more]

PMID: 30938035

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Project description:IntroductionImpaired fasting glucose (IFG) is a significant risk factor for diabetes mellitus. Time-restricted eating (TRE) is one type of diet showing positive effects on metabolic signal pathways. However, effects of TRE on cardiometabolic risk factors in humans are limited. Additionally, compliance with TRE remains problematic despite having intention to follow the diet control. Therefore, this study aims to investigate the efficacy of TRE with behavioural economic interventions or TRE alone relative to usual care, in reducing fasting plasma glucose (FPG), haemoglobin A1c (HbA1c) and other cardiometabolic risk factors in patients with IFG.Methods and analysisThis parallel-group, open-label randomised controlled trial will be conducted at the outpatient clinic of the Department of Family Medicine, Faculty of Medicine, Ramathibodi Hospital, Bangkok, Thailand. Patients aged 18-65 years with IFG defined as FPG 100-125 mg/dL and body mass index ≥25 kg/m2 will be recruited between October 2021 and October 2022. Patients will be randomly allocated to three groups (1:1:1 ratio) as (1) TRE with behavioural economic interventions including financial incentives and text reminders, (2) TRE alone or (3) usual care. The number of participants will be 38 per group (a total of 114). The duration of the intervention will be 12 weeks. Primary outcome is FPG levels measured at 12 weeks after randomisation. Secondary outcomes are HbA1c, body weight, systolic and diastolic blood pressure, fasting insulin, serum triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and high-sensitivity C reactive protein. P value of <0.05 of two-sided test will be considered as statistical significance.Ethics and disseminationThe study protocol has been approved by the Ethics Committee of the Faculty of Medicine, Ramathibodi Hospital, Mahidol University (MURA2021/389). All patients will be informed about the details of the study and sign written informed consent before enrollment in the study. Results from this study will be published in a peer-reviewed journal.Trial registration numberTCTR20210520002.

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Dataset Information

Determining the optimal fasting glucose target for patients with type 2 diabetes: Results of the multicentre, open-label, randomized-controlled FPG GOAL trial.

Publications

Determining the optimal fasting glucose target for patients with type 2 diabetes: Results of the multicentre, open-label, randomized-controlled FPG GOAL trial.

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