N/A
Completed N=30
Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study
Source: ClinicalTrials.gov NCT05074667 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use — 7; 2; 1; 0 Participants
Summary
The purpose of this pilot feasibility study is to provide continued CGM access to youth with type 2 diabetes and collect descriptive data about feasibility of use of CGM in youth with type 2 diabetes ages 4 years and older. From this study the investigators hope to learn if CGM use in youth with type 2 diabetes can be tolerated and sustained with good adherence and to describe blood glucose patterns in youth with type 2 diabetes. The primary aim will be to evaluate the feasibility of CGM start and continuation in youth with T2D and describe glucose metrics and patient reported outcomes (PROs). The investigators will pilot and refine a program to test the hypothesis that CGM start and continuation in youth with T2D is feasible and then evaluate glucose metrics and PROs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use |
7; 2; 1; 0; 0 | — |
| SECONDARY Mean HbA1C |
10.18; 10.16; 8.95; 9.27; 10.04; 9.77 | — |
| SECONDARY Time With Glucose Values in Target Range of 70-180 mg/dL |
71; 45.5; 59; 28.5; 42 | — |
| SECONDARY PROMIS Global Health Overall Scale Score |
37.20; 35.60; 32.40 | — |
| SECONDARY PedsQL 3.2 Overall Scale Score - Participant Rated |
58.33; 65.00; 58.33; 65.53; 59.85; 55.30 | — |
| SECONDARY PedsQL 3.2 Scale Score - Parent Rated |
65.00; 60.00; 59.17; 64.39; 59.85; 57.58 | — |
| SECONDARY Diabetes Technology Attitudes (DTA) - Participant Rated |
3.78; 4.50; 4.00 | — |
| SECONDARY Diabetes Technology Attitudes (DTA) - Parent Rated |
3.80; 4.00; 3.60 | — |
| SECONDARY Problem Areas in Diabetes-Teen Version (PAID-T) Overall Scale Score - Participant Rated |
43.50; 47.00; 52.00 | — |
| SECONDARY Problem Areas in Diabetes (P-PAID) Overall Scale Score - Parent Rated |
55.00; 59.00; 50.50 | — |
Eligibility Criteria
Inclusion Criteria
- public insurance
- between ages 4-19.99 years inclusive
- diagnosis of T2D (diabetes autoantibody negative) followed in the Pediatric Endocrinology clinic at Stanford Children's Health
- HbA1C greater than 6.5% at enrollment
- interested in starting on a continuous glucose monitor
- have access to a mobile device that is compatible with CGM applications or willing to use CGM receiver provided
Exclusion Criteria
- non-T2D diagnosis
- HgA1C < 6.5%
- are not willing to wear CGM
- have private health insurance.
Data sourced from ClinicalTrials.gov (NCT05074667). 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.