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

NYU Langone Health

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Device: CGMS Device; Other: No Device

Study type: Interventional

Funder types: Other

Identifiers

NCT03020069

16-01011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 13 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Glucose Meter

Experimental group

Description:

Continuing Glucose Monitoring Device

Treatment:

Device: CGMS Device

No Glucose Meter

Active Comparator group

Description:

Average Blood glucose measure

Treatment:

Other: No Device