Dataset Information

Structured self-monitoring of blood glucose reduces glycated hemoglobin in insulin-treated diabetes.

ABSTRACT: The aim of the preset study was to investigate the effectiveness of structured self-monitoring of blood glucose (SMBG) in insufficiently controlled insulin-treated diabetes. A total of 86 insulin-treated patients were randomized to a routine testing group (RTG; n = 43) and a structured testing group (STG; n = 43). The STG used a chart to record seven-point blood glucose (BG) profile on three consecutive days per month. The primary end-point was the glycated hemoglobin (HbA1c) at 3 months and 6 months. There were no significant differences of HbA1c between the RTG and STG at 3 months. However, the STG had significantly improved HbA1c at 6-month follow-up compared with the RTG (P = 0.002). In the STG, HbA1c decreased by 0.5% from 7.9 (SD 0.5) to 7.4 (0.7)%, whereas it decreased by 0.1% in the RTG from 7.9 (0.5) to 7.8 (0.7)%. In the STG, 55% of the patients were willing to continue structured SMBG and they achieved a 0.7% decrease of HbA1c. The present findings suggest that structured SMBG significantly improves glycemic control.

SUBMITTER: Kato N

PROVIDER: S-EPMC4025113 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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Structured self-monitoring of blood glucose reduces glycated hemoglobin in insulin-treated diabetes.

Kato Noriko N Cui Jinyan J Kato Mitsutoshi M

Journal of diabetes investigation 20130418 5

The aim of the preset study was to investigate the effectiveness of structured self-monitoring of blood glucose (SMBG) in insufficiently controlled insulin-treated diabetes. A total of 86 insulin-treated patients were randomized to a routine testing group (RTG; n = 43) and a structured testing group (STG; n = 43). The STG used a chart to record seven-point blood glucose (BG) profile on three consecutive days per month. The primary end-point was the glycated hemoglobin (HbA1c) at 3 months and 6 m ...[more]

PMID: 24843694

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Project description:IntroductionMedical treatment options for type 2 diabetes (T2D) have increased over the last decade and enhance the possibility of individualised treatment strategies where insulin is still one of them. In spite of the advancements in treatment options, less than one-third of the population with T2D obtain their optimal glycaemic goal. In persons with type 1 diabetes, continuous glucose monitoring (CGM) has shown to be the most important driver for improvement in glycaemic control, even more than insulin-pump therapy. The use of technology in T2D has only been investigated in few studies.The overall objective of the research study is to examine the effectiveness of the use of CGM versus self-monitoring of blood glucose (SMBG) in persons with insulin-treated T2D on glycaemic variables and patient-reported outcomes on treatment satisfaction, health behaviour and well-being. The independent effect of peer support will also be studied.Methods and analysisThe study is a single centre, prospective, randomised, open-labelled, three-armed study with the randomisation 2:1:2 in group A with CGM, group B with CGM and peer support, and group C as a control group with SMBG. The participants receive a training course unique for the allocation group. The study runs for 12 months and includes 100 adult participants with insulin-treated T2D, treated at the outpatient clinic at Steno Diabetes Center Copenhagen. Primary outcome is difference in change in time in range. Recruitment begins in August 2020 and ends in July 2021. Final 12-month follow-up is anticipated to be in August 2022.Ethics and disseminationThe study will be carried out in accordance with the Helsinki Declaration and is approved by the Scientific Ethics Committee of the Capital Region (H-20000843). Data collection and handling will be performed in accordance with the General Data Protection Regulation and is approved by the Danish Data Protection Agency (J-2020-100). Dissemination will be in international peer-reviewed journals, conferences and a plain-language summary for participants.Trial registration numberClinicalTrials.gov Registry (NCT04331444).Protocol versionV.3, 11 December 2020.

Project description:AimTo examine the impact of structured self-monitoring of blood glucose, with or without TeleCare support, on glycaemic control in people with sub-optimally controlled Type 2 diabetes.MethodsWe conducted a 12-month, multicentre, randomized controlled trial in people with established (>1 year) Type 2 diabetes not on insulin therapy, with sub-optimal glycaemic control [HbA1c ≥58 to ≤119 mmol/mol (≥7.5% to ≤13%)]. A total of 446 participants were randomized to a control group (n =151) receiving usual diabetes care, a group using structured self-monitoring of blood glucose alone (n =147) or a group using structured self-monitoring of blood glucose with additional monthly 'TeleCare' support (n =148). The primary outcome was HbA1c at 12 months.ResultsA total of 323 participants (72%) completed the study; 116 (77%) in the control group, 99 (67%) in the self-monitoring of blood glucose alone group and 108 (73%) in the self-monitoring of blood glucose plus TeleCare group. Compared to baseline, the mean HbA1c was lower in all groups at 12 months, with reductions of 3.3 mmol/mol (95% CI -5.71 to -0.78) or 0.3% (95% CI -0.52 to -0.07; P=0.01) in the control group, 11.4 mmol/mol (95% CI -14.11 to -8.76) or 1.1% (-1.29 to -0.81; P<0.0001) in the group using self-monitoring of blood glucose alone and 12.8 mmol/mol (95% CI -15.34 to -10.31) or 1.2% (95% CI -1.40 to -0.94; P<0.0001) in the group using self-monitoring of blood glucose plus TeleCare. This represents a reduction in HbA1c of 8.9 mmol/mol (95% CI -11.97 to -5.84) or 0.8% (95% CI -1.10 to -0.54; P≤0.0001) with structured self-monitoring of blood glucose compared to the control group. Participants with lower baseline HbA1c , shorter duration of diabetes and higher educational achievement were more likely to achieve HbA1c ≤53 mmol/mol (7.0%).ConclusionsStructured self-monitoring of blood glucose provides clinical and statistical improvements in glycaemic control in Type 2 diabetes. No additional benefit, over and above the use of structured self-monitoring of blood glucose, was observed in glycaemic control with the addition of once-monthly TeleCare support. (Clinical trial registration no.: ISRCTN21390608).

Dataset Information

Structured self-monitoring of blood glucose reduces glycated hemoglobin in insulin-treated diabetes.

Publications

Structured self-monitoring of blood glucose reduces glycated hemoglobin in insulin-treated diabetes.

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