Dataset Information

Effects of Patient-Driven Lifestyle Modification Using Intermittently Scanned Continuous Glucose Monitoring in Patients With Type 2 Diabetes: Results From the Randomized Open-label PDF Study.

ABSTRACT:

Objective

To investigate the effects of patient-driven lifestyle modification using intermittently scanned continuous glucose monitoring (isCGM) in patients with type 2 diabetes (T2D).

Research design and methods

We conducted a 12-week, open-label, randomized controlled trial. A total of 126 participants were 1:1 randomized to either the intervention group (structured education + isCGM) or the control group (standard care with blood glucose monitoring). The Self-Evaluation Of Unhealthy foods by Looking at postprandial glucose (SEOUL) algorithm was developed and applied to aid structured education in guiding patients to follow healthy eating behavior depending on the postprandial glycemic response. The primary end point was the change in HbA1c level from baseline.

Results

Implementation of the SEOUL algorithm with isCGM was associated with greater improvement in HbA1c than with standard care (risk-adjusted difference -0.50%, 95% CI -0.74 to -0.26, P < 0.001). Participants in the intervention group had a greater reduction in fasting blood glucose and body weight (-16.5 mg/dL, 95% CI -30.0 to -3.0, P = 0.017; -1.5 kg, 95% CI -2.7 to -0.3, P = 0.013, respectively). The score sum for the Korean version of the revised Summary of Diabetes Self-Care Activities Questionnaire increased in both groups but to a greater extent in the intervention group (mean difference 4.8, 95% CI 1.7-8.0, P = 0.003). No severe hyperglycemia or hypoglycemia was reported in either group of patients.

Conclusions

Patient-driven lifestyle modification primarily focused on eating behavior using isCGM effectively lowered HbA1c levels in patients with T2D.

SUBMITTER: Choe HJ

PROVIDER: S-EPMC9862445 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

Effects of Patient-Driven Lifestyle Modification Using Intermittently Scanned Continuous Glucose Monitoring in Patients With Type 2 Diabetes: Results From the Randomized Open-label PDF Study.

Choe Hun Jee HJ Rhee Eun-Jung EJ Won Jong Chul JC Park Kyong Soo KS Lee Won-Young WY Cho Young Min YM

Diabetes care 20221001 10

<h4>Objective</h4>To investigate the effects of patient-driven lifestyle modification using intermittently scanned continuous glucose monitoring (isCGM) in patients with type 2 diabetes (T2D).<h4>Research design and methods</h4>We conducted a 12-week, open-label, randomized controlled trial. A total of 126 participants were 1:1 randomized to either the intervention group (structured education + isCGM) or the control group (standard care with blood glucose monitoring). The Self-Evaluation Of Unhe ...[more]

PMID: 35984640

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Project description:BackgroundAdvances in diabetes technology have been exponential in the last few decades. With evolution in continuous glucose monitoring (CGM) systems and its progressive automation in control of insulin delivery, these advances have changed type 1 diabetes mellitus (T1DM) management. These novel technologies have the potential to improve glycated haemoglobin (HbA1c), reduce hypoglycaemic events, increase time spent in range and improve quality of life (QoL). Our aim was to evaluate the sustained effects in free-living unsupervised conditions of CGM systems (intermittently scanned and real time) and insulin delivery [from multiple daily injections, via sensor-augmented pump therapy and (predictive) low-glucose insulin suspension to hybrid closed-loop systems] on glucose control and QoL in adults and children with T1DM.MethodsWe performed a systematic review of randomized controlled trials (RCTs), using PubMed and the Cochrane library up to 30 May 2019. Inclusion of RCTs was based on type of intervention (comparing glucose-monitoring devices and insulin-delivery devices), population (nonpregnant adults and children with T1DM), follow-up (outpatient setting for at least 8 weeks) and relevant outcomes [HbA1c, time in range (TIR), time in target, time in hypoglycaemia and QoL]. Exclusion of RCTs was based on intervention (exercise, only overnight use). The Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines were used to score the quality of the papers and for the final selection of the articles.ResultsOur search resulted in 214 articles, of which 19 were eligible. Studies on advanced use in adults and children with T1DM reported increased TIR (all 9 studies); decreased time in hypoglycaemia (13 out of 15 studies); lowered HbA1c levels (5 out of 15 studies); improved QoL (10 of 16 studies) and treatment satisfaction (7 studies).ConclusionsRecent technologies have dramatically changed the course of T1DM. They are proving useful in controlling glycaemia in patients with T1DM, without increasing the treatment burden.

Project description:BackgroundIncidence of gestational diabetes mellitus (GDM) is increasing and is associated with adverse perinatal outcomes including macrosomia, pre-eclampsia, and pre-term delivery. Optimum glycaemic control can reduce these adverse perinatal outcomes. Continuous glucose monitoring (CGM) informs users about interstitial glucose levels allowing early detection of glycaemic excursions and pharmacological or behavioural intervention. Few adequately powered RCTs to evaluate the impact of using CGM in women with GDM on perinatal outcomes have been undertaken. We aim to establish the feasibility of a multi-site RCT to evaluate the clinical- and cost-effectiveness of an intermittently scanned continuous glucose monitor (isCGM) compared with self-monitored blood glucose (SMBG) in women with GDM for reducing fetal macrosomia and improving maternal and fetal outcomes. We will evaluate recruitment and retention rates, adherence to device requirements, adequacy of data capture and acceptability of trial design and isCGM devices.MethodsOpen-label multicentre randomised controlled feasibility trial.Inclusion criteriapregnant women, singleton pregnancy, recent diagnosis of GDM (within 14 days of commencing medication, up to 34 weeks gestation) prescribed metformin and/or insulin. Women will be consecutively recruited and randomised to isCGM (FreestyleLibre2) or SMBG. At every antenatal visit, glucose measurements will be evaluated. The SMBG group will use blinded isCGM for 14 days at baseline (~ 12-32 weeks) and ~ 34-36 weeks. The primary outcome is the recruitment rate and absolute number of women participating. Clinical assessments of maternal and fetal/infant health will be undertaken at baseline, birth, up to ~ 13 weeks post-natal. Psychological, behavioural and health economic measures will be assessed at baseline and ~ 34-36 weeks gestation. Qualitative interviews will be undertaken with study decliners, participants, and professionals to explore trial acceptability, of using isCGM and SMBG.DiscussionGDM can be associated with adverse pregnancy outcomes. isCGM could offer a timely, easy-to-engage-with intervention, to improve glycaemic control, potentially reducing adverse pregnancy, birth and long-term health outcomes for mother and child. This study will determine the feasibility of conducting a large-scale multisite RCT of isCGM in women with GDM.Trial registrationThis study has been registered with the ISRCTN (reference: ISRCTN42125256 , Date registered: 07/11/2022).

Dataset Information

Effects of Patient-Driven Lifestyle Modification Using Intermittently Scanned Continuous Glucose Monitoring in Patients With Type 2 Diabetes: Results From the Randomized Open-label PDF Study.

Objective

Research design and methods

Results

Conclusions

Publications

Effects of Patient-Driven Lifestyle Modification Using Intermittently Scanned Continuous Glucose Monitoring in Patients With Type 2 Diabetes: Results From the Randomized Open-label PDF Study.

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