Intensive Diabetes Clinic and Intermittent Continuous Glucose Monitoring in Adolescents With Type 1 Diabetes Mellitus in Poor Glycemic Control
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- University Hospitals Cleveland Medical Center
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Glycemic Control
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this research study is to find out ways to help pre-teens and teens and their families to improve diabetes control and to help with the burden of diabetes management. Specifically, the study aims to find out if coming to diabetes clinic more frequently and for a longer period of time helps adolescents with diabetes, and if adolescents who wear a continuous glucose monitor (CGM) for 3-5 days a month will have better diabetes control.
Detailed Description
Good glycemic control is critical in preventing chronic complications of type 1 diabetes. However, achieving good glycemic control remains elusive for many adolescents. This study evaluates two clinic-based approaches for improving glycemic control in adolescents with poorly controlled type 1 diabetes - an intensive diabetes support and education program alone and the same intensive diabetes support and education program together with continuous glucose monitoring - in comparison with standard diabetes care.
Investigators
Sarah A. MacLeish
Physician
University Hospitals Cleveland Medical Center
Eligibility Criteria
Inclusion Criteria
- •Type 1 diabetes mellitus of at least 12 months duration, followed by Rainbow Babies and Children's Pediatric Endocrinology and Diabetes Division
- •Most recent HbA1c \>= 8.5%
- •Patients must be willing to check their blood sugar at least 4 times daily while wearing the CGM
- •Patients and families must be willing to come to diabetes clinic once a month for 4 months
Exclusion Criteria
- •Inability to understand and/or speak the English language
- •Pregnancy
- •Psychological counseling with Dr. Rebecca Hazen regarding diabetes adherence prior to the study
Outcomes
Primary Outcomes
Glycemic Control
Time Frame: Baseline and visit 4
Serum hemoglobin A1c (HbA1c) will be measured in all groups at the baseline visit and visit 4.
Secondary Outcomes
- Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL)(Total from baseline to visit 4)
- Satisfaction With Intensive Diabetes Clinic and Usage of the Continuous Glucose Monitor(Visit 4)
- Adherence to Prescribed Diabetes Regimen(Baseline and visit 4)
- Diabetes Knowledge(Baseline and month 4)
- Insulin Dose Changes(Baseline and visit 4)