N/A
N=116
Use of Continuous Glucose Sensors by Adolescents With Inadequate Diabetic Control
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00945659 ↗Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Glycated Hemoglobin (HbA1c) — 8.84; 9.03; 9.24; 9.14 percentage of hemoglobin molecules — p=0.86
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous Glucose Sensor (Device); Standard Care (Other); CGS + Behavior Therapy (Behavioral)
- Age
- Pediatric · 11+ yrs
- Sex
- All
- Sponsor
- Nemours Children's Clinic
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycated Hemoglobin (HbA1c) |
8.84; 9.03; 9.24; 9.14; 9.06; 8.96 | 0.86 |
| SECONDARY Diabetes Technology Questionnaire-Adolescents |
96.50; 101.73; 105.16; 102.24; 92.50; 105.95 | 0.03 sig |
| SECONDARY Diabetes Technology Questionnaire-Parents' Total Scores on DTQ Current Items |
90.06; 91.68; 86.87; 90.48; 93.78; 95.92 | 0.49 |
| SECONDARY Blood Glucose Monitoring Communication Questionnaire-Adolescent |
14.24; 14.46; 14.29; 14.46; 14.43; 13.54 | 0.64 |
| SECONDARY Blood Glucose Monitoring Communication Questionnaire-Parents |
14.08; 14.59; 14.29; 14.46; 15.13; 12.84 | 0.99 |
| SECONDARY Diabetes Family Conflict Scale-Adolescent |
27.72; 27.54; 27.59; 27.41; 29.70; 25.26 | 0.43 |
| SECONDARY Diabetes Family Conflict Scale-Parent |
28.76; 27.76; 27.75; 29.36; 30.29; 24.85 | 0.43 |
| SECONDARY Diabetes Family Responsibility Questionnaire-Adolescent |
31.53; 31.15; 31.38; 31.20; 31.56; 30.48 | 0.75 |
| SECONDARY Diabetes Family Responsibility Questionnaire-Parent |
34.44; 35.19; 33.97; 34.22; 34.23; 33.62 | 0.58 |
| SECONDARY Diabetes Self Management Profile-Adolescent |
57.05; 60.25; 59.38; 56.82; 58.73; 57.79 | 0.46 |
| SECONDARY Diabetes Self Management Profile-Parent |
52.76; 55.45; 55.94; 54.15; 58.18; 59.07 | 0.93 |
| SECONDARY Hypoglycemia Fear Survey-Adolescent |
36.94; 35.8; 35.39; 35.95; 37.15; 31.00 | 0.81 |
| SECONDARY Hypoglycemia Fear Survey-Parent |
43.31; 43.5; 44.09; 40.07; 41.56; 39.79 | 0.71 |
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.
Eligibility Criteria
Inclusion Criteria
- Age of adolescent > 11 years and 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00945659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.