Use of Continuous Glucose Sensors by Adolescents With Inadequate Diabetic Control

NCT00945659 | Completed Results DMC

• 1 other identifier: 1R01DK080831
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The incorporation of continuous glucose sensors (CGS) into management of type 1 diabetes in adolescence could improve treatment outcomes. But, behavioral barriers may prevent adolescents from enjoying optimal benefits from this new technology. This study will randomize adolescents (11 to not yet 17 years old) with type 1 diabetes for at least 2 years who are not achieving targeted HbA1c levels (\> 7.5%) to continue in standard care (SC), to add continuous glucose monitoring (CGM) to their care with appropriate education and medical management (CGS) or to add CGM to their care as above but to also receive support and assistance from a behavior therapist who will assist the patient and family in optimizing the adolescents' therapeutic benefit from CGS (CGS+BT). A variety of outcomes will be measured, including blood glucose control, quality of life, and CGS satisfaction and impact. An enrollment criterion for this study is that the adolescent must have established consistent care for type 1 diabetes at a Nemours Children's Clinic location either in Wilmington, DE, Philadelphia, PA, Orlando, FL or Pensacola, FL for at least 12 months prior to enrollment in the study. Adolescents treated elsewhere are not eligible to enroll in the study.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Glycated Hemoglobin (HbA1c)

  Glycated hemoglobin (HbA1c) expressed as a percentage of hemoglobin molecules bound to glucose.

  Baseline, 3, 6, 9 months

Secondary Outcomes (12)

• Diabetes Technology Questionnaire-Adolescents

  Baseline, 3 6, 9 months

• Diabetes Technology Questionnaire-Parents' Total Scores on DTQ Current Items

  Baseline, 3, 6, 9 months

• Blood Glucose Monitoring Communication Questionnaire-Adolescent

  Baseline, 3, 6, 9 months

• Blood Glucose Monitoring Communication Questionnaire-Parents

  Baseline, 3, 6, 9 months

• Diabetes Family Conflict Scale-Adolescent

  Baseline, 3, 6, 9 months

Study Arms (3)

Standard Care

ACTIVE COMPARATOR

Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.

Other: Standard Care

Continuous Glucose Sensor

ACTIVE COMPARATOR

Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.

Device: Continuous Glucose Sensor

CGS + Behavior Therapy

EXPERIMENTAL

Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.

Behavioral: CGS + Behavior Therapy

Interventions

Continuous Glucose Sensor DEVICE

Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.

Continuous Glucose Sensor

Standard Care OTHER

Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.

Standard Care

CGS + Behavior Therapy BEHAVIORAL

Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.

CGS + Behavior Therapy

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age of adolescent \> 11 years and \< 17 years. This age range was chosen because families of adolescents often struggle with diabetes management. Youths \> 18 years old may be likely to leave home during the study.
• Diagnosis of type 1 diabetes based on the clinician's best judgment regarding the adolescent's proper diagnostic category.
• Duration of type 1 diabetes \> 2 years or \> 1 year with negligible stimulated c-peptide level, to exclude those with significant residual pancreatic insulin production.
• Treatment of diabetes for the 6 months prior to enrollment must consist of an intensified regimen including either daily use of an insulin pump or 3 or more daily insulin injections with pre-meal insulin doses calculated using a correction factor that considers prevailing blood glucose levels and planned carbohydrate intake.
• Adolescent must have established diabetes care at a participating Nemours Children's Clinic site as evidenced by at least two diabetes clinic visits within the prior 12 months.
• Most recent HbA1C \> 7.5% and \< 10.0% or mean HbA1C over the prior 12 months within that same range.
• Intention to remain in the same region and to maintain diabetes care at the enrolling center for 12 months.
• Family has working telephone service.

You may not qualify if:

• Youth has not used a CGM device with real-time glucose feedback for clinical management of diabetes within the prior 6 months. Intermittent or one-time use of "blinded" CGM devices for retrospective analysis only is permissible.
• Absence of any other medical conditions that, in the opinion of the attending endocrinologist, would impede completion of the study protocol.
• Youths may not be on daily glucocorticoid medications due to hyperglycemic effects of these agents.
• Not enrolled in special education for mental retardation, autism or severe behavior disorders.
• Child not in an inpatient psychiatric unit or day treatment program during the 6 months prior to enrollment.
• Primary diabetes caregiver not diagnosed or in treatment for major depression, psychosis, bipolar disorder or substance use disorder within the 6 months prior to enrollment; Child not in an inpatient psychiatric unit or day treatment program during the 6 months prior to enrollment.

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Standard of Care; Behavior Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Tim Wysocki, PhD
• Organization: Nemours Foundation: Dept. of Biomedical Research

twysocki@nemours.org

904-697-3483

Study Officials

• Tim Wysocki, Ph.D.

  Nemours Children's Clinic Jacksonville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Research Scientist and Center Director

Model Details: 3 group (Standard Care: Continuous Glucose Monitor; Continuous Glucose Monitor + Behavior Therapy) X 4 time points (0, 3, 6, and 9 months) Repeated measures randomized treatments design.

Study Record Dates

• First Submitted: July 23, 2009
• First Posted: July 24, 2009
• Study Start: August 1, 2009
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: September 10, 2018
• Results First Posted: September 10, 2018

Record last verified: 2018-08

Locations

US (1)