Use of Continuous Glucose Monitoring System With Intensive Feedback in Adolescents With Poorly Controlled Type 1 Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Other: No Device; Device: CGMS Device

• Registration Number: NCT03020069
• Lead Sponsor: NYU Langone Health

Brief Summary

The purpose of this study is to determine that continuous glucose monitoring systems (CGMS) with intensive real time feedback about diabetes management from medical staff to the patient will affect motivation and/or behavior, in adolescents with poorly controlled type 1 diabetes. The investigators hypothesize that short-term CGMS use with feedback (and/or lack thereof) and patients' sense of self-efficacy will influence their stage of change and potentially glucose levels.

Detailed Description

Sixty adolescents, ages 13-19 years, with type 1 diabetes and an HbA1c \> = 8 % who are also naive to CGMS use will be recruited from the diabetes outpatient population followed at Bellevue Hospital, Lutheran Hospital, Woodhull Hospital, and the NYU Fink Pediatric Ambulatory Care Center. Forty subjects will be randomly assigned to the CGMS group and 20 subjects will be assigned to the control group.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-13
• Primary Completion: 2018-07-13
• Study Completion: 2018-07-13
• Results First Submitted: 2020-02-06
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-12
• Last Update Submitted: 2020-03-12
• Results First Posted: 2020-03-16
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• type 1 diabetes
• HbA1c > = 8 %
• naive to CGMS use

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Exclusion Criteria

• Patients with developmental delay
• Patients who do not use a glucose meter to test capillary blood glucose level
• Patients without access to a telephone will be excluded.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Glucose Meter	No Device	Average Blood glucose measure
Glucose Meter	CGMS Device	Continuing Glucose Monitoring Device

Primary Outcome Measures

Name	Time	Method
Change in Score of Pediatric Quality of Life Inventory 3.2 Diabetes Module (Peds QL 3.2) From Baseline to 3 Months	Baseline, 3 Months	The PedsQL 3.2 Diabetes Module is composed of 33 items. Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The total score is calculated as the sum of all items over the number of items answered on all the scales (total score ranges from 0-3300). Higher scores indicate lower problems. The change in total score is calculated by subtracting the total score at baseline from the total score at 3 months.
Change in Glycated Hemoglobin (HbA1c) Levels From Baseline to 3 Months	Baseline, 3 Months	HbA1c measurements will be measured in the lab at the location of the patient's visit at baseline and 3 months. The measured HbA1c level at 3 months will be subtracted from the measured level at baseline to calculate the change.
Change in Level of Blood Sugar (Glucose) From Baseline to 3 Months	Baseline, 3 Months	Blood sugar (glucose) will be measured via glucose monitors. The change in level of blood sugar will be calculated by subtracting the blood glucose level at 3 months from the blood glucose level at baseline.
Change in Score of Diabetes Empowerment Scale Short Form (DES-SF) From Baseline to 3 Months	Baseline, 3 months	There are 8 items that constitute the DES-SF. The scale is scored by averaging the scores of all completed items. 1 = strongly disagree and 5 = strongly agree. The change in score between baseline and 3 months will be calculated by subtracting the average score from 3 months from the baseline score.

Trial Locations

Locations (1)

New York University Medical Center; 🇺🇸 New York, New York, United States