Glycemic Outcomes of Use of CLC vs PLGS in Type 1 Diabetes: A Randomized, Controlled Trial

2020 ◽  
Author(s):  
Sue A. Brown ◽  
Roy W. Beck ◽  
Dan Raghinaru ◽  
Bruce A. Buckingham ◽  
Lori M. Laffel ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Controlled Trial ◽  
Limited Information ◽  
Loop Control ◽  
Measured Time ◽  
Device Use ◽  
Intent To Treat ◽  
Glycemic Outcomes ◽  
Age Range

<u>Background:</u> Limited information is available about glycemic outcomes with closed-loop control (CLC) compared with predictive-low glucose suspend (PLGS). <p><u>Methods:</u> After 6 months of use of a CLC system in a randomized trial, 109 participants with type 1 diabetes (age range 14 to 72 years, mean HbA1c 7.1% [54 mmol/mol]) were randomly assigned to CLC (N=54, Control-IQ) or PLGS (N=55, Basal-IQ) for 3 months. Primary outcome was CGM-measured time in range (TIR 70-180mg/dL). Baseline CGM metrics were computed from the last 3 months of the preceding study. <br> <u>Results</u>: All 109 participants completed the study. Mean±SD TIR was 71.1±11.2% at baseline and 67.6±12.6% using intent-to-treat analysis (69.1±12.2% using per-protocol analysis excluding periods of study-wide suspension of device use) over 13 weeks on CLC versus 70.0±13.6% and 60.4±17.1% on PLGS (difference = +5.9%, 95%CI +3.6 to +8.3; P<0.001]). Time >180mg/dL was lower in the CLC group than PLGS group (difference = -6.0%, 95%CI -8.4 to -3.7, p<0.001]) while time <54 mg/dL was similar (0.04%, 95% CI -0.05% to +0.13%; P=0.41). HbA1c after 13 weeks was lower on CLC than PLGS (7.2% [55 mmol/mol] versus 7.5% [56 mmol/mol], difference -0.34% [-3.7 mmol/mol], 95% CI -0.57 [-6.2 mmol/mol] to -0.11% [1.2 mmol/mol]; P=0.0035).<br> <u>Conclusion: </u>Following 6 months of CLC, switching to PLGS reduced TIR and increased HbA1c towards their pre-CLC values while hypoglycemia remained similarly reduced with both CLC and PLGS.</p>

scholarly journals Glycemic Outcomes of Use of CLC vs PLGS in Type 1 Diabetes: A Randomized, Controlled Trial

2020 ◽  
Author(s):  
Sue A. Brown ◽  
Roy W. Beck ◽  
Dan Raghinaru ◽  
Bruce A. Buckingham ◽  
Lori M. Laffel ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Controlled Trial ◽  
Limited Information ◽  
Loop Control ◽  
Measured Time ◽  
Device Use ◽  
Intent To Treat ◽  
Glycemic Outcomes ◽  
Age Range

<u>Background:</u> Limited information is available about glycemic outcomes with closed-loop control (CLC) compared with predictive-low glucose suspend (PLGS). <p><u>Methods:</u> After 6 months of use of a CLC system in a randomized trial, 109 participants with type 1 diabetes (age range 14 to 72 years, mean HbA1c 7.1% [54 mmol/mol]) were randomly assigned to CLC (N=54, Control-IQ) or PLGS (N=55, Basal-IQ) for 3 months. Primary outcome was CGM-measured time in range (TIR 70-180mg/dL). Baseline CGM metrics were computed from the last 3 months of the preceding study. <br> <u>Results</u>: All 109 participants completed the study. Mean±SD TIR was 71.1±11.2% at baseline and 67.6±12.6% using intent-to-treat analysis (69.1±12.2% using per-protocol analysis excluding periods of study-wide suspension of device use) over 13 weeks on CLC versus 70.0±13.6% and 60.4±17.1% on PLGS (difference = +5.9%, 95%CI +3.6 to +8.3; P<0.001]). Time >180mg/dL was lower in the CLC group than PLGS group (difference = -6.0%, 95%CI -8.4 to -3.7, p<0.001]) while time <54 mg/dL was similar (0.04%, 95% CI -0.05% to +0.13%; P=0.41). HbA1c after 13 weeks was lower on CLC than PLGS (7.2% [55 mmol/mol] versus 7.5% [56 mmol/mol], difference -0.34% [-3.7 mmol/mol], 95% CI -0.57 [-6.2 mmol/mol] to -0.11% [1.2 mmol/mol]; P=0.0035).<br> <u>Conclusion: </u>Following 6 months of CLC, switching to PLGS reduced TIR and increased HbA1c towards their pre-CLC values while hypoglycemia remained similarly reduced with both CLC and PLGS.</p>

scholarly journals Glycemic Outcomes of Use of CLC Versus PLGS in Type 1 Diabetes: A Randomized Controlled Trial

Diabetes Care ◽  
2020 ◽  
Vol 43 (8) ◽  
pp. 1822-1828 ◽  
Author(s):  
Sue A. Brown ◽  
Roy W. Beck ◽  
Dan Raghinaru ◽  
Bruce A. Buckingham ◽  
Lori M. Laffel ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Type 1 Diabetes ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Glycemic Outcomes

scholarly journals Text message reminders for adolescents with poorly controlled type 1 diabetes: A randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0248549
Author(s):  
Nour Ibrahim ◽  
Jean-Marc Treluyer ◽  
Nelly Briand ◽  
Cécile Godot ◽  
Michel Polak ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Hba1c Level ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Baseline Hba1c ◽  
Randomized Controlled ◽  
Intent To Treat ◽  
Treat Analysis

Background Among adolescents with type 1 diabetes, some experience great difficulties with treatment adherence, putting them at high risk of complications. We assessed the effect of text messaging (Short Messaging Service [SMS]) on glycemic control. Methods A two-arm open label randomized controlled trial enrolled adolescents with type 1 diabetes aged 12–21 years with baseline HbA1c ≥ 69 mmol/mol (8.5%). The intervention group received daily SMS reminders at self-selected times about insulin injections while the control group received standard of care. The patients allocated to the control group were not aware of the intervention. Results 92 patients were randomized, 45 in the SMS arm and 47 in the control arm. After 6 months, median HbA1c level was significantly lower in the intervention arm: 73 mmol/mol (8.8%) in the SMS arm and 83 mmol/mol (9.7%) in the control arm in the intent-to-treat analysis (P = 0.03) but no longer in the per protocol analysis (P = 0.65). When we consider the proportions of patients whose HbA1c level decreased by at least 1% between baseline and 6 months, we find a significant difference among patients whose baseline HbA1c was ≥ 80 mmol/mol (9.5%) (n = 56): 60% in the SMS arm and 30.6% in the control arm had lowered their HbA1c level (P = 0.03) in the intent-to-treat analysis but not in the per-protocol analysis (P = 0.50). Patients in the SMS arm reported high satisfaction with the intervention. Conclusions While there is a trend to lower HbA1c in the intervention group, no firm conclusions can yet be drawn. Further studies are needed to address methodological issues as we believe these interventions can support behavior change among adolescents with poorly controlled type 1 diabetes. ClinicalTrials.gov identifier: NCT02230137.

scholarly journals Oral insulin immunotherapy in children at risk for type 1 diabetes in a randomised controlled trial

Diabetologia ◽  
2021 ◽  
Author(s):  
Robin Assfalg ◽  
Jan Knoop ◽  
Kristi L. Hoffman ◽  
Markus Pfirrmann ◽  
Jose Maria Zapardiel-Gonzalo ◽  
...  
Keyword(s):  
Immune Response ◽  
Type 1 Diabetes ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Antibody Responses ◽  
Oral Insulin ◽  
Cell Responses ◽  
Randomised Controlled

Abstract Aims/hypothesis Oral administration of antigen can induce immunological tolerance. Insulin is a key autoantigen in childhood type 1 diabetes. Here, oral insulin was given as antigen-specific immunotherapy before the onset of autoimmunity in children from age 6 months to assess its safety and immune response actions on immunity and the gut microbiome. Methods A phase I/II randomised controlled trial was performed in a single clinical study centre in Germany. Participants were 44 islet autoantibody-negative children aged 6 months to 2.99 years who had a first-degree relative with type 1 diabetes and a susceptible HLA DR4-DQ8-containing genotype. Children were randomised 1:1 to daily oral insulin (7.5 mg with dose escalation to 67.5 mg) or placebo for 12 months using a web-based computer system. The primary outcome was immune efficacy pre-specified as induction of antibody or T cell responses to insulin and measured in a central treatment-blinded laboratory. Results Randomisation was performed in 44 children. One child in the placebo group was withdrawn after the first study visit and data from 22 insulin-treated and 21 placebo-treated children were analysed. Oral insulin was well tolerated with no changes in metabolic variables. Immune responses to insulin were observed in children who received both insulin (54.5%) and placebo (66.7%), and the trial did not demonstrate an effect on its primary outcome (p = 0.54). In exploratory analyses, there was preliminary evidence that the immune response and gut microbiome were modified by the INS genotype Among children with the type 1 diabetes-susceptible INS genotype (n = 22), antibody responses to insulin were more frequent in insulin-treated (72.7%) as compared with placebo-treated children (18.2%; p = 0.03). T cell responses to insulin were modified by treatment-independent inflammatory episodes. Conclusions/interpretation The study demonstrated that oral insulin immunotherapy in young genetically at-risk children was safe, but was not associated with an immune response as predefined in the trial primary outcome. Exploratory analyses suggested that antibody responses to oral insulin may occur in children with a susceptible INS genotype, and that inflammatory episodes may promote the activation of insulin-responsive T cells. Trial registration Clinicaltrials.gov NCT02547519 Funding The main funding source was the German Center for Diabetes Research (DZD e.V.) Graphical abstract

scholarly journals Feasibility study of real-time online text-based CBT to support self-management for people with type 1 diabetes: the Diabetes On-line Therapy (DOT) Study

2021 ◽  
Vol 9 (1) ◽  
pp. e001934
Author(s):  
Anne M Doherty ◽  
Anne Herrmann-Werner ◽  
Arann Rowe ◽  
Jennie Brown ◽  
Scott Weich ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Real Time ◽  
Instant Messaging ◽  
Controlled Trial ◽  
Self Management ◽  
Diabetes Distress ◽  
The Mean ◽  
Distress Scale

IntroductionThis study examines the feasibility of conducting diabetes-focused cognitive–behavioral therapy (CBT) via a secure online real-time instant messaging system intervention to support self-management and improve glycemic control in people with type 1 diabetes.Research design and methodsWe used a pre–post uncontrolled intervention design over 12 months. We recruited adults with type 1 diabetes and suboptimal glycemic control (HbA1c ≥69 mmol/mol (DCCT 8.5%) for 12 months) across four hospitals in London. The intervention comprised 10 sessions of diabetes-focused CBT delivered by diabetes specialist nurses. The primary outcomes were number of eligible patients, rates of recruitment and follow-up, number of sessions completed and SD of the main outcome measure, change in HbA1c over 12 months. We measured the feasibility of collecting secondary outcomes, that is, depression measured using Patient Health Questionnaire-9 (PHQ-9), anxiety measured Generalised Anxiety Disorder (GAD) and the Diabetes Distress Scale (DDS).ResultsWe screened 3177 patients, of whom 638 were potentially eligible, from whom 71 (11.1%) were recruited. The mean age was 28.1 (13.1) years, and the mean HbA1c was 84.6 mmol/mol (17.8), DCCT 9.9%. Forty-six (65%) patients had at least 1 session and 29 (41%) completed all sessions. There was a significant reduction in HbA1c over 12 months (mean difference −6.2 (2.3) mmol/mol, DCCT 0.6%, p=0.038). The change scores in PHQ-9, GAD and DDS also improved.ConclusionsIt would be feasible to conduct a full-scale text-based synchronized real-time diabetes-focused CBT as an efficacy randomized controlled trial.

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