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Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes.

ABSTRACT: To determine whether short-time, real-time continuous glucose monitoring (RT-CGM) has long-term salutary glycemic effects in patients with type 2 diabetes who are not on prandial insulin.This was a randomized controlled trial of 100 adults with type 2 diabetes who were not on prandial insulin. This study compared the effects of 12 weeks of intermittent RT-CGM with self-monitoring of blood glucose (SMBG) on glycemic control over a 40-week follow-up period. Subjects received diabetes care from their regular provider without therapeutic intervention from the study team.There was a significant difference in A1C at the end of the 3-month active intervention that was sustained during the follow-up period. The mean, unadjusted A1C decreased by 1.0, 1.2, 0.8, and 0.8% in the RT-CGM group vs. 0.5, 0.5, 0.5, and 0.2% in the SMBG group at 12, 24, 38, and 52 weeks, respectively (P = 0.04). There was a significantly greater decline in A1C over the course of the study for the RT-CGM group than for the SMBG group, after adjusting for covariates (P < 0.0001). The subjects who used RT-CGM per protocol (?48 days) improved the most (P < 0.0001). The improvement in the RT-CGM group occurred without a greater intensification of medication compared with those in the SMBG group.Subjects with type 2 diabetes not on prandial insulin who used RT-CGM intermittently for 12 weeks significantly improved glycemic control at 12 weeks and sustained the improvement without RT-CGM during the 40-week follow-up period, compared with those who used only SMBG.

SUBMITTER: Vigersky RA

PROVIDER: S-EPMC3241321 | biostudies-literature | 2012 Jan

REPOSITORIES: biostudies-literature

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Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes.

Vigersky Robert A RA Fonda Stephanie J SJ Chellappa Mary M Walker M Susan MS Ehrhardt Nicole M NM

Diabetes care 20111118 1

<h4>Objective</h4>To determine whether short-time, real-time continuous glucose monitoring (RT-CGM) has long-term salutary glycemic effects in patients with type 2 diabetes who are not on prandial insulin.<h4>Research design and methods</h4>This was a randomized controlled trial of 100 adults with type 2 diabetes who were not on prandial insulin. This study compared the effects of 12 weeks of intermittent RT-CGM with self-monitoring of blood glucose (SMBG) on glycemic control over a 40-week foll ...[more]

PMID: 22100963

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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.

Dataset Information

Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes.

Publications

Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes.

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