Use of Continuous Glucose Sensors by Adolescents With Inadequate Diabetic Control (CGM-Teens)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Nemours Children's Clinic.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT00945659
First received: July 23, 2009
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Device: Continuous Glucose Sensor
Other: Standard Care
Behavioral: CGS + Behavior Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Use of Continuous Glucose Sensors by Adolescents With Inadequate Diabetic Control

Resource links provided by NLM:


Further study details as provided by Nemours Children's Clinic:

Primary Outcome Measures:
  • Glycated hemoglobin (HbA1c) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diabetes Technology Questionnaire [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: August 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Care
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
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.
Active Comparator: Continuous Glucose Sensor
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
Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
Experimental: CGS + Behavior Therapy
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
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.

Detailed Description:

Management of type 1 diabetes mellitus (T1DM) in adolescents is very difficult and innovative approaches are needed to help them achieve better glycemic control and behavioral outcomes. Continuous glucose sensors (CGS) have been refined progressively and provide acceptably accurate, nearly continuous estimates of glucose levels and trends. This increased quality and quantity of glucose data could be an excellent adjunct to conventional self-monitoring of blood glucose, permitting more informed diabetes decision-making. CGS could yield medical, educational and psychological benefits for adolescents with T1DM, but those with extremely variable self-management habits and suboptimal glycemic control may not realize these benefits readily. We hypothesize that a targeted, family-focused behavioral intervention could optimize benefit from adding CGS to T1DM therapy for youths with glycosylated hemoglobin (HbA1c) > 7.5%. A multi-site sample of 150 adolescents with T1DM and HbA1C of 7.5% to 10.0% will be randomized to either Standard Care for T1DM (SC), or to augmentation of SC with 9 months' use of a CGS device (CGS) or use of a CGS device supplemented with a targeted behavior therapy intervention (CGS+BT). Multiple measures of glycemic control, glycemic variability and health care use will be obtained during the study and there will be periodic assessments of demographic factors, diabetes self-management, family relations and psychological adjustment. Three specific aims will be addressed: 1. Evaluate whether CGS+BT yields more improvement in glycemic outcomes than CGS or SC; 2. Evaluate whether CGS+BT yields more improvement in behavioral outcomes than CGS or SC; and 3. Identify behavioral variables that mediate and moderate glycemic benefit from use of the CGS device. The study will also compare the cost effectiveness of CGS and CGS+BT relative to SC and evaluate the predictive utility of various indices of glycemic variability in youths. We hypothesize that, compared with SC and CGS, CGS+BT will yield significantly better biomedical outcomes (HbA1C; severe hypoglycemia; glycemic variability; proportion of glucose readings in the normal range) and behavioral outcomes (treatment adherence; parent adolescent teamwork; diabetes-related family conflict; quality of life; fear of hypoglycemia; and treatment satisfaction). After the 9 month randomized trial, all youths will be allowed to use the CGS device during an additional 3-month continuation phase. Statistical analyses will be based on individual growth modeling techniques. The application capitalizes on the Principal Investigator's prior and ongoing funded research on family management of T1DM, including trials of family-focused behavioral interventions, intensive therapy regimens, and clinical evaluations of continuous glucose sensors. The proposed study will determine whether a targeted behavioral intervention improves CGS benefits among adolescents with previously inadequate glycemic control. These results could demonstrate that adolescents with previously suboptimal diabetic control could realize multiple benefits from CGS use if they are provided with a specialized behavioral intervention.

  Eligibility

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Diagnosis of type 1 diabetes based on the clinician's best judgment regarding the adolescent's proper diagnostic category.
  3. 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.
  4. 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.
  5. 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.
  6. Most recent HbA1C > 7.5% and < 10.0% or mean HbA1C over the prior 12 months within that same range.
  7. Intention to remain in the same region and to maintain diabetes care at the enrolling center for 12 months.
  8. Family has working telephone service.

Exclusion Criteria:

  1. 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.
  2. Absence of any other medical conditions that, in the opinion of the attending endocrinologist, would impede completion of the study protocol.
  3. Youths may not be on daily glucocorticoid medications due to hyperglycemic effects of these agents.
  4. Not enrolled in special education for mental retardation, autism or severe behavior disorders.
  5. Child not in an inpatient psychiatric unit or day treatment program during the 6 months prior to enrollment.
  6. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945659

Contacts
Contact: Tim Wysocki, Ph.D. 904-697-3488 twysocki@nemours.org

Locations
United States, Florida
Nemours Children's Clinic Recruiting
Jacksonville, Florida, United States, 32207
Principal Investigator: Tim Wysocki, Ph.D.         
Sponsors and Collaborators
Nemours Children's Clinic
Investigators
Principal Investigator: Tim Wysocki, Ph.D. Nemours Children's Clinic Jacksonville
  More Information

No publications provided

Responsible Party: Tim Wysocki, Ph.D., Nemours Children's Clinic, Jacksonville, Florida
ClinicalTrials.gov Identifier: NCT00945659     History of Changes
Other Study ID Numbers: 1-R01-DK080831, 1-R01-DK080831
Study First Received: July 23, 2009
Last Updated: July 20, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 27, 2014