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

January 3, 2022 updated by: Sarah A. MacLeish, University Hospitals Cleveland Medical Center

Intensive Diabetes Clinic and Intermittent Continuous Glucose Monitoring in Adolescents With Type 1 Diabetes Mellitus in Poor Glycemic Control

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Standard Diabetes Care
Patients will attend diabetes clinic as usual, once every 3 months.
EXPERIMENTAL: Intensive Diabetes Clinic
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.
Behavioral: Diabetes related psychological counseling and education
The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
Other Names:
  • Diabetes Education
  • Diabetes Psychological Counseling
EXPERIMENTAL: Intensive Diabetes Clinic plus CGM
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.
Behavioral: Diabetes related psychological counseling and education
The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
Other Names:
  • Diabetes Education
  • Diabetes Psychological Counseling
Device: Continuous Glucose Monitor
Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months.
Other Names:
  • Medtronic Minimed iPro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and visit 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Dose Changes
Time Frame: Baseline and visit 4
Insulin doses in units per kilogram per day will be calculated at baseline and visit 4.
Baseline and visit 4
Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL)
Time Frame: 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.
Total from baseline to visit 4
Adherence to Prescribed Diabetes Regimen
Time Frame: 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).
Baseline and visit 4
Satisfaction With Intensive Diabetes Clinic and Usage of the Continuous Glucose Monitor
Time Frame: 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.
Visit 4
Diabetes Knowledge
Time Frame: 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.
Baseline and month 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Sarah A MacLeish, D.O., UHCMC Division of Pediatric Endocrinology
  • Principal Investigator: Rebecca A Hazen, Ph.D., UHCMC Division of Behavioral Pediatrics
  • Principal Investigator: Leona Cuttler, M.D, UHCMC Division of Pediatric Endocrinology
  • Principal Investigator: Rose Gubitosi-Klug, M.D, Ph.D., UHCMC Division of Pediatric Endocrinology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

March 8, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (ESTIMATE)

March 9, 2010

Study Record Updates

Last Update Posted (ACTUAL)

January 13, 2022

Last Update Submitted That Met QC Criteria

January 3, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBCDM-01
  • MH018830 (OTHER_GRANT: TRN503976)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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