Browse
Submit Data
Databases
API
Help

Dataset Information

24 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

Effectiveness of continuous glucose monitoring in a clinical care environment: evidence from the Juvenile Diabetes Research Foundation continuous glucose monitoring (JDRF-CGM) trial.

ABSTRACT:

Objective

To determine whether continuous glucose monitoring (CGM) is effective in the management of type 1 diabetes when implemented in a manner that more closely approximates clinical practice.

Research design and methods

After completion of a 6-month randomized controlled trial (RCT) evaluating CGM in children, adolescents, and adults with type 1 diabetes, CGM was initiated in the trial's control group with less intensive training and follow-up than was included in the RCT. Subjects had an outpatient training session, two follow-up phone calls, and outpatient visits at 1, 4, 13, and 26 weeks. For subjects with baseline A1C > or =7.0%, the primary outcome was change in A1C at 6 months.

Results

CGM use decreased from a median of 7.0 days/week in the first month in the > or =25-year-old group, 6.3 days/week in the 15-24 year olds, and 6.8 days/week in the 8-14 year olds to 6.5, 3.3, and 3.7 days/week in the 6th month, respectively (P < 0.001 for each age-group). Among subjects with baseline A1C > or =7.0%, CGM use was associated with A1C reduction after 6 months (P = 0.02 adjusted for age-group). Severe hypoglycemia decreased from 27.7 events per 100 person-years in the 6-month control phase of the RCT to 15.0 events per 100 person-years in the 6-month follow-up CGM phase (P = 0.08).

Conclusions

Frequent use of CGM in a clinical care setting may improve A1C and reduce episodes of hypoglycemia. However, sustained frequent use of CGM is less likely in children and adolescents than in adults.

SUBMITTER: Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group

PROVIDER: S-EPMC2797966 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Json Xml

Similar Datasets

Modeling continuous glucose monitoring (CGM) data during sleep.

Project description:We introduce a multilevel functional Beta model to quantify the blood glucose levels measured by continuous glucose monitors for multiple days in study participants with type 2 diabetes mellitus. The model estimates the subject-specific marginal quantiles, quantifies the within- and between-subject variability, and produces interpretable parameters of blood glucose dynamics as a function of time from the actigraphy-estimated sleep onset. Results are validated via simulations and by studying the association between the estimated model parameters and hemoglobin A1c, the gold standard for assessing glucose control in diabetes.

| S-EPMC8942115 | biostudies-literature

Persistence of individual variations in glycated hemoglobin: analysis of data from the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Randomized Trial.

Project description:ObjectiveTo determine the individual persistence of the relationship between mean sensor glucose (MG) concentrations and hemoglobin A(1c) (A1C) from the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring (CGM) Randomized Trial.Research design and methodsMG was calculated using CGM data for 3 months before A1C measurements at 3, 6, 9, and 12 months for the CGM group and at 9 and 12 months for the control group. An MG-to-A1C ratio was included in analysis for subjects who averaged ≥4 days/week of CGM use.ResultsSpearman correlations of the MG-to-A1C ratio between consecutive visits 3 months apart ranged from 0.70 to 0.79. The correlations for children and youth were slightly smaller than those for adults. No meaningful differences were observed by device type or change in A1C.ConclusionsIndividual variations in the rate of hemoglobin glycation are persistent and contribute to the inaccuracy in estimating MGs calculated from A1C levels.

| S-EPMC3114360 | biostudies-literature

Quality-of-life measures in children and adults with type 1 diabetes: Juvenile Diabetes Research Foundation Continuous Glucose Monitoring randomized trial.

Project description:ObjectiveTo evaluate the impact of continuous glucose monitoring (CGM) on quality of life (QOL) among individuals with type 1 diabetes.Research design and methodsIn a multicenter trial, 451 children and adults with type 1 diabetes were randomly assigned to CGM treatment or the control group. Generic and diabetes-specific QOL questionnaires were completed at baseline and 26 weeks by all participants and parents of participants <18 years old, and the CGM satisfaction scale was completed by the CGM group (participants and parents) at 26 weeks.ResultsAfter 26 weeks, QOL scores remained largely unchanged for both the treatment and the control group, although there was a slight difference favoring the adult CGM group on several subscales (P < 0.05). There was substantial satisfaction with CGM technology after 26 weeks among participants and parents.ConclusionsBaseline QOL was high, and the measures showed little change with CGM use, although a high level of CGM satisfaction was reported.

| S-EPMC2945155 | biostudies-literature

The JDRF CCTN CGM TIME Trial: Timing of Initiation of continuous glucose Monitoring in Established pediatric type 1 diabetes: study protocol, recruitment and baseline characteristics.

Project description:BackgroundContinuous glucose monitoring (CGM) has been shown to improve glucose control in adults with type 1 diabetes. Effectiveness of CGM is directly linked with CGM adherence, which can be challenging to maintain in children and adolescents. We hypothesize that initiating CGM at the same time as starting insulin pump therapy in pump naïve children and adolescents with type 1 diabetes will result in greater CGM adherence and effectiveness compared to delaying CGM introduction by 6 months, and that this is related to greater readiness for making behaviour change at the time of pump initiation.Methods/designThe CGM TIME Trial is a multicenter randomized controlled trial. Eligible children and adolescents (5-18 years) with established type 1 diabetes were randomized to simultaneous initiation of pump (Medtronic Veo©) and CGM (Enlite©) or to standard pump therapy with delayed CGM introduction. Primary outcomes are CGM adherence and hemoglobin A1C at 6 and 12 months post pump initiation. Secondary outcomes include glycemic variability, stage of readiness, and other patient-reported outcomes with follow-up to 24 months. 144 (95%) of the 152 eligible patients were enrolled and randomized. Allowing for 10% withdrawals, this will provide 93% power to detect a between group difference in CGM adherence and 86% power to detect a between group difference in hemoglobin A1C. Baseline characteristics were similar between the treatment groups. Analysis of 12 month primary outcomes will begin in September 2014.DiscussionThe CGM TIME Trial is the first study to examine the relationship between timing of CGM initiation, readiness for behaviour change, and subsequent CGM adherence in pump naïve children and adolescents. Its findings will advance our understanding of when and how to initiate CGM in children and adolescents with type 1 diabetes.Trial registrationClinicalTrial.gov NCT01295788. Registered 14 February 2011.

| S-EPMC4109785 | biostudies-literature

Hemoglobin A1c and mean glucose in patients with type 1 diabetes: analysis of data from the Juvenile Diabetes Research Foundation continuous glucose monitoring randomized trial.

Project description:To determine the relationship between mean sensor glucose concentrations and hemoglobin A(1c) (HbA(1c)) values measured in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications laboratory at the University of Minnesota in a cohort of subjects with type 1 diabetes from the Juvenile Diabetes Research Foundation continuous glucose monitoring randomized trial.Near-continuous glucose sensor data (? 4 days/week) were collected for 3 months before a central laboratory-measured HbA(1c) was performed for 252 subjects aged 8-74 years, the majority of whom had stable HbA(1c) values (77% within ± 0.4% of the patient mean).The slope (95% CI) for mean sensor glucose concentration (area under the curve) versus a centrally measured HbA(1c) was 24.4 mg/dL (22.0-26.7) for each 1% change in HbA(1c), with an intercept of -16.2 mg/dL (-32.9 to 0.6). Although the slope did not vary with age or sex, there was substantial individual variability, with mean sensor glucose concentrations ranging from 128 to 187 mg/dL for an HbA(1c) of 6.9-7.1%. The root mean square of the errors between the actual mean sensor glucose concentration versus the value calculated using the regression equation was 14.3 mg/dL, whereas the median absolute difference was 10.1 mg/dL.There is substantial individual variability between the measured versus calculated mean glucose concentrations. Consequently, estimated average glucose concentrations calculated from measured HbA(1c) values should be used with caution.

| S-EPMC3041177 | biostudies-literature

CGM Benefits and Burdens: Two Brief Measures of Continuous Glucose Monitoring.

Project description:BackgroundContinuous glucose monitors (CGM) are underutilized by individuals with type 1 diabetes (T1D), particularly during the adolescent years. Little is known about perceptions of CGM benefit and burdens, and few tools exist to quantify this information.MethodsTwo questionnaires were developed and validated-Benefit of CGM (BenCGM) and Burdens of CGM (BurCGM)-in a sample of adolescents ages 12-19 years involved in the T1D Exchange Registry. We chose to start the validation process with adolescents given their low CGM uptake and high risk for suboptimal glycemic outcomes. Exploratory and confirmatory factor analyses were conducted to confirm factor structure and select items. The resultant scales were tested for internal reliability and convergent/divergent validity with critical diabetes and quality of life outcomes: age, depression, diabetes distress, self-efficacy, technology attitudes, and diabetes technology attitudes.ResultsA total of 431 adolescents with T1D completed the questionnaires (51% female, mean age 16.3 ± 2.26, 83% white non-Hispanic, 70% having used CGM). Two single factor scales emerged, and scales were reduced to 8 items each. Those who perceived higher benefit of CGM exhibited lower diabetes distress, higher self-efficacy, and more positive attitudes toward technology. Those who perceived higher burden of CGM exhibited higher diabetes distress, lower self-efficacy, and less positive technology attitudes.ConclusionThe BenCGM and BurCGM questionnaires each comprise 8-items that demonstrate robust psychometric properties for use in adolescents with T1D, and can be used to develop targeted interventions to increase CGM wear to improve diabetes management.

| S-EPMC6835174 | biostudies-literature

Factors predictive of severe hypoglycemia in type 1 diabetes: analysis from the Juvenile Diabetes Research Foundation continuous glucose monitoring randomized control trial dataset.

Project description:Identify factors predictive of severe hypoglycemia (SH) and assess the clinical utility of continuous glucose monitoring (CGM) to warn of impending SH.In a multicenter randomized clinical trial, 436 children and adults with type 1 diabetes were randomized to a treatment group that used CGM (N = 224), or a control group that used standard home blood glucose monitoring (N = 212) and completed 12 months of follow-up. After 6 months, the original control group initiated CGM while the treatment group continued use of CGM for 6 months. Baseline risk factors for SH were evaluated over 12 months of follow-up using proportional hazards regression. CGM-derived indices of hypoglycemia were used to predict episodes of SH over a 24-h time horizon.The SH rate was 17.9 per 100 person-years, and a higher rate was associated with the occurrence of SH in the prior 6 months and female sex. SH frequency increased eightfold when 30% of CGM values were ? 70 mg/dL on the prior day (4.5 vs. 0.5%; P < 0.001), but the positive predictive value (PPV) was low (<5%). Results were similar for hypoglycemic area under the curve and the low blood glucose index calculated by CGM.SH in the 6 months prior to the study was the strongest predictor of SH during the study. CGM-measured hypoglycemia over a 24-h span is highly associated with SH the following day (P < 0.001), but the PPV is low.

| S-EPMC3041185 | biostudies-literature

Accuracy of Continuous Glucose Monitoring (CGM) during Continuous and High-Intensity Interval Exercise in Patients with Type 1 Diabetes Mellitus.

Project description:Continuous exercise (CON) and high-intensity interval exercise (HIIE) can be safely performed with type 1 diabetes mellitus (T1DM). Additionally, continuous glucose monitoring (CGM) systems may serve as a tool to reduce the risk of exercise-induced hypoglycemia. It is unclear if CGM is accurate during CON and HIIE at different mean workloads. Seven T1DM patients performed CON and HIIE at 5% below (L) and above (M) the first lactate turn point (LTP₁), and 5% below the second lactate turn point (LTP₂) (H) on a cycle ergometer. Glucose was measured via CGM and in capillary blood (BG). Differences were found in comparison of CGM vs. BG in three out of the six tests (p < 0.05). In CON, bias and levels of agreement for L, M, and H were found at: 0.85 (-3.44, 5.15) mmol·L(-1), -0.45 (-3.95, 3.05) mmol·L(-1), -0.31 (-8.83, 8.20) mmol·L(-1) and at 1.17 (-2.06, 4.40) mmol·L(-1), 0.11 (-5.79, 6.01) mmol·L(-1), 1.48 (-2.60, 5.57) mmol·L(-1) in HIIE for the same intensities. Clinically-acceptable results (except for CON H) were found. CGM estimated BG to be clinically acceptable, except for CON H. Additionally, using CGM may increase avoidance of exercise-induced hypoglycemia, but usual BG control should be performed during intense exercise.

| S-EPMC4997402 | biostudies-literature

Glucose management for exercise using continuous glucose monitoring (CGM) and intermittently scanned CGM (isCGM) systems in type 1 diabetes: position statement of the European Association for the Study of Diabetes (EASD) and of the International Society for Pediatric and Adolescent Diabetes (ISPAD) endorsed by JDRF and supported by the American Diabetes Association (ADA).

Project description:Physical exercise is an important component in the management of type 1 diabetes across the lifespan. Yet, acute exercise increases the risk of dysglycaemia, and the direction of glycaemic excursions depends, to some extent, on the intensity and duration of the type of exercise. Understandably, fear of hypoglycaemia is one of the strongest barriers to incorporating exercise into daily life. Risk of hypoglycaemia during and after exercise can be lowered when insulin-dose adjustments are made and/or additional carbohydrates are consumed. Glycaemic management during exercise has been made easier with continuous glucose monitoring (CGM) and intermittently scanned continuous glucose monitoring (isCGM) systems; however, because of the complexity of CGM and isCGM systems, both individuals with type 1 diabetes and their healthcare professionals may struggle with the interpretation of given information to maximise the technological potential for effective use around exercise (ie, before, during and after). This position statement highlights the recent advancements in CGM and isCGM technology, with a focus on the evidence base for their efficacy to sense glucose around exercise and adaptations in the use of these emerging tools, and updates the guidance for exercise in adults, children and adolescents with type 1 diabetes.

| S-EPMC7702152 | biostudies-literature

Continuous glucose monitoring.

Project description: Not available

| S-EPMC10699474 | biostudies-literature