Trial results for a study investigating self-management in young adults with Type 1 Diabetes were posted on ClinicalTrials.gov on 2025-07-31, involving 39 participants.
Background
Type 1 Diabetes (T1D) affects 1.6 million Americans, and only 14% of young adults age 18-25 years achieve glycemic targets (glycosylated hemoglobin A1C <7.0%). Achieving glycemic targets is associated with reduced risk for both micro-and macrovascular complications, better neurocognitive function, and better diabetes quality of life. In lab studies, sleep deprivation led to impaired glucose tolerance and insulin sensitivity in adults without chronic condition and in one study of adults with T1D. Extending sleep in natural environments contributes to improved insulin sensitivity and glucose le.
Trial design
This completed study, designated as Phase NA, enrolled 39 participants to investigate Type 1 Diabetes. The trial compared two self-management strategies: a Sleep Self-Management approach and a Diabetes Self-Management Education approach. No primary outcomes were listed for this study.
Key results
The trial reported several key measurements across the two intervention groups:
- Non-dominant Wrist-worn Actigraph to be Worn 24/7 (Spectrum Plus) (min per night):
- Sleep Self-Management group: Mean of 18 (Standard Error 0.17).
- Diabetes Self-Management Education group: Mean of -25.8 (Standard Error 0.17).
- Time in Range 70-180 mg/dL (percentage of time):
- Sleep Self-Management group: Mean of 0.82 (Standard Error 4.35).
- Diabetes Self-Management Education group: Mean of -0.35 (Standard Error 5.07).
- Diabetes Self-Management Questionnaire (27-item) (score on a scale):
- Sleep Self-Management group: Mean of 0 (Standard Error 1.40).
- Diabetes Self-Management Education group: Mean of 0.44 (Standard Error 1.65).
- Paper-based Trail Making Test Parts A and B (Executive Function) (time in seconds):
- Sleep Self-Management group: Mean of -2.93 (Standard Error 0.79).
- Diabetes Self-Management Education group: Mean of -0.92 (Standard Error 0.84).
- Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression Short Form (score on a scale):
- Sleep Self-Management group: Mean of 1.17 (Standard Error 2.06).
- Diabetes Self-Management Education group: Mean of -0.34 (Standard Error 2.41).
- Diabetes Distress Scale (17-item) (score on a scale):
- Sleep Self-Management group: Mean of -3.01 (Standard Error 3.03).
- Diabetes Self-Management Education group: Mean of -2.22 (Standard Error 2.35).
A Mixed Models Analysis reported a Cohen's D of 0.17 with a 95.0% Confidence Interval of -0.37 to 0.78, and a p-value of 0.0227.
What this means
The posted results provide descriptive data on the impact of two self-management strategies—Sleep Self-Management and Diabetes Self-Management Education—on various outcomes in young adults with Type 1 Diabetes. The Sleep Self-Management group showed an increase of 18 min per night in actigraph-measured sleep, while the Diabetes Self-Management Education group showed a decrease of 25.8 min per night. Modest changes were observed in Time in Range for both groups. Improvements in executive function, as measured by the Trail Making Test, were noted in both groups, with a larger decrease in time for the Sleep Self-Management group. Changes in self-management questionnaire scores, depression, and diabetes distress varied between the groups. A statistically significant difference (p-value of 0.0227) was observed in a Mixed Models Analysis, indicating a notable effect, though the specific outcome associated with this analysis is not detailed in the available data.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04975230, titled "Self-Management in Young Adults With Type 1 Diabetes", were posted on 2025-07-31 on clinicaltrials.gov.