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

Not Applicable

Completed

Conditions: Type 1 Diabetes Mellitus

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

Registration Number: NCT01083433

Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 68

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive Diabetes Clinic	Diabetes related psychological counseling and education	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.
Intensive Diabetes Clinic plus CGM	Diabetes related psychological counseling and education	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.
Intensive Diabetes Clinic plus CGM	Continuous Glucose Monitor	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.

Primary Outcome Measures

Name	Time	Method
Glycemic Control	Baseline and visit 4	Serum hemoglobin A1c (HbA1c) will be measured in all groups at the baseline visit and visit 4.

Secondary Outcome Measures

Name	Time	Method
Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL)	Total from baseline to visit 4	CGM downloads at baseline and visit 4 will be used to tabulate the number of episodes of blood glucoses \< 70 mg/dL. At each visit patients will be asked to recall any episodes of severe hypoglycemia that occurred since the last visit. Data from the continuous glucose monitors will be used to evaluate the percent of time that patients are below 70 mg/dL and the number of glucose excursions below 70 mg/dL. Total number of excursions under 70 mg/dL from baseline to visit 4 will be added together.
Satisfaction With Intensive Diabetes Clinic and Usage of the Continuous Glucose Monitor	Visit 4	Survey of patient and parent satisfaction in the interventions groups only, satisfaction with the overall study including CGM use and psychological intervention. Satisfaction measured on a 7 point Likert scale, with highest satisfaction at a score of 7 and lowest score 1.
Adherence to Prescribed Diabetes Regimen	Baseline and visit 4	Diabetes Self Management Profile, given to participant (child) at baseline and visit 4. Minimum score zero, maximum score 88. A higher score indicates better adherence. The DSMP is a 10-15 minute, 25-question, validated, structured interview of adherence with diabetes self-management tasks administered separately to parents and youth. It was verbally administered by one pediatric endocrinologist and one trained research assistant. It assesses self-management of exercise and hypoglycemia (7 questions), carbohydrate counting and insulin dose calculation (6 questions), blood glucose and ketone monitoring (8 questions), and insulin timing and dosing (4 questions).
Diabetes Knowledge	Baseline and month 4	The Diabetes Knowledge Questionnaire was adapted from Butler et al. It is a written questionnaire, self administered independently to parents and children to assess their knowledge about diabetes management. It includes 37 multiple choice questions assessing basic information about diabetes, how to deal with diabetes-related tasks, and management of hypothetical situations. A total score out of 37 possible points is computed for diabetes knowledge, score can range from 0-37. A higher score indicates higher knowledge.
Insulin Dose Changes	Baseline and visit 4	Insulin doses in units per kilogram per day will be calculated at baseline and visit 4.