Use of Continuous Glucose Sensors by Adolescents With Inadequate Diabetic Control
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

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.
    

Intervention name(s): Continuous Glucose Sensor; Standard Care; CGS + Behavior Therapy
Intervention type(s): Device; Other; Behavioral
Intervention description(s): Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Health Services Research