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

ABSTRACT: To evaluate the impact of continuous glucose monitoring (CGM) on quality of life (QOL) among individuals with type 1 diabetes.In 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.After 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.Baseline QOL was high, and the measures showed little change with CGM use, although a high level of CGM satisfaction was reported.

SUBMITTER: Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group

PROVIDER: S-EPMC2945155 | biostudies-literature | 2010 Oct

REPOSITORIES: biostudies-literature

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

Beck Roy W RW Lawrence Jean M JM Laffel Lori L Wysocki Tim T Xing Dongyuan D Huang Elbert S ES Ives Brett B Kollman Craig C Lee Joyce J Ruedy Katrina J KJ Tamborlane William V WV

Diabetes care 20100809 10

<h4>Objective</h4>To evaluate the impact of continuous glucose monitoring (CGM) on quality of life (QOL) among individuals with type 1 diabetes.<h4>Research design and methods</h4>In 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 co ...[more]

PMID: 20696865

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Project description:ObjectiveContinuous glucose monitoring (CGM) is the standard of care for glucose monitoring in children with diabetes, however there are limited data reporting their use in hyperinsulinaemic hypoglycaemia (HH). Here, we evaluate CGM accuracy and its impact on quality of life in children with HH.MethodsReal-time CGM (Dexcom G5 and G6) was used in children with HH aged 0-16years. Data from self-monitoring capillary blood glucose (CBG) and CGM were collected over a period of up to 28days and analysed. Quality of life was assessed by the PedsQL4.0 general module and PedsQL2.0 family impact module, completed by children and their parents/carers before and after CGM insertion. Analysis of accuracy metrics included mean absolute relative difference (MARD) and proportion of CGM values within 15, 20, and 30% or 15, 20, and 30 mg/dL of reference glucose values >100 mg/dL or ≤100 mg/dL, respectively (% 15/15, % 20/20, % 30/30). Clinical reliability was assessed with Clarke error grid (CEG) analyses.ResultsProspective longitudinal study with data analysed from 40 children. The overall MARD between reference glucose and paired CGM values (n=4,928) was 13.0% (Dexcom G5 12.8%, Dexcom G6 13.1%). The proportion of readings meeting %15/15 and %20/20 were 77.3% and 86.4%, respectively, with CEG analysis demonstrating 97.4% of all values in zones A and B. Within the hypoglycaemia range (<70 mg/dL), the median ARD was 11.4% with a sensitivity and specificity of 64.2% and 91.3%, respectively. Overall PedsQL child report at baseline and endpoint were 57.6 (50.5 - 75.8) and 87.0 (82.9 - 91.2), and for parents were 60.3 (44.8 - 66.0) and 85.3 (83.7 - 91.3), respectively (both p<0.001).ConclusionUse of CGM for children with HH is feasible, with clinically acceptable accuracy, particularly in the hypoglycaemic range. Quality of life measures demonstrate significant improvement after CGM use. These data are important to explore use of CGM in disease indications, including neonatal and paediatric diabetes, cystic fibrosis and glycogen storage disorders.

Dataset Information

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

Publications

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

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