N/A
Completed N=13
Use of Continuous Glucose Monitoring System With Intensive Feedback in Adolescents With Poorly Controlled Type 1 Diabetes
Source: ClinicalTrials.gov NCT03020069 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Change in Score of Pediatric Quality of Life Inventory 3.2 Diabetes Module (Peds QL 3.2) From Baseline to 3 Months — 6.4; -3.8 score on a scale
Summary
The purpose of this study is to determine that continuous glucose monitoring systems (CGMS) with intensive real time feedback about diabetes management from medical staff to the patient will affect motivation and/or behavior, in adolescents with poorly controlled type 1 diabetes. The investigators hypothesize that short-term CGMS use with feedback (and/or lack thereof) and patients' sense of self-efficacy will influence their stage of change and potentially glucose levels.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Score of Pediatric Quality of Life Inventory 3.2 Diabetes Module (Peds QL 3.2) From Baseline to 3 Months |
6.4; -3.8 | — |
| PRIMARY Change in Glycated Hemoglobin (HbA1c) Levels From Baseline to 3 Months |
-9.4; -36 | — |
| PRIMARY Change in Level of Blood Sugar (Glucose) From Baseline to 3 Months |
-0.1; 0 | — |
| PRIMARY Change in Score of Diabetes Empowerment Scale Short Form (DES-SF) From Baseline to 3 Months |
0.375; -0.25 | — |
Eligibility Criteria
Inclusion Criteria
- type 1 diabetes
- HbA1c > = 8 %
- naive to CGMS use
Exclusion Criteria
- Patients with developmental delay
- Patients who do not use a glucose meter to test capillary blood glucose level
- Patients without access to a telephone will be excluded.
Data sourced from ClinicalTrials.gov (NCT03020069). 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. Informational only — not medical advice.