Study to Find Out if Intensive Diabetes Clinic and Continuous Glucose Monitors Help Teenagers With Diabetes

University Hospitals (UH)

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: Continuous Glucose Monitor; Behavioral: Diabetes related psychological counseling and education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01083433

RBCDM-01

MH018830 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 3 patient groups

Standard Diabetes Care

No Intervention group

Description:

Patients will attend diabetes clinic as usual, once every 3 months.

Intensive Diabetes Clinic

Experimental group

Description:

Patients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist.

Treatment:

Behavioral: Diabetes related psychological counseling and education

Intensive Diabetes Clinic plus CGM

Experimental group

Description:

Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a continuous glucose monitor for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.

Treatment:

Behavioral: Diabetes related psychological counseling and education

Device: Continuous Glucose Monitor