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NCT04506151 · ClinicalTrials.gov record · last posted 2026-08-27

Sleep Optimization to Improve Glycemic Control in Adults With Type 1 Diabetes

Study acronym: SOPT
StatusCompleted
PhaseNot applicable
Started2021-01-19
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
Up to 40% of adults with type 1 diabetes have insufficient sleep which is associated with negative health consequences including poor blood glucose control and greater diabetes complications. In this study, a sleep intervention (Sleep-Opt) that uses wearable sleep tracking technology, telephone coaching and informational content designed to improve sleep and glycemic control in working-age adults with type 1 diabetes. Sleep-Opt could lead to reduced development of diabetes complications and improve quality of life for adults with type 1 diabetes.

Protocol amendment history 4 changes detected by DataLookout

2026-08-28
notable
Trial completed
2026-08-28
critical
Primary endpoint(s) modified
WasGlycemic control, Sleep duration, Sleep variability
NowHbA1C Week 12, HbA1C Week 24, HbA1C Week 6, Sleep Duration Week 12, Sleep Duration Week 24, Sleep Duration Week 6, Sleep Variability Week 12, Sleep Variability Week 24, Sleep Variability Week 6
2026-08-28
minor
Completion moved earlier: 2026-04-30 → 2025-12-21
2026-08-28
notable
Results posted: 2026-08-27
Trial Details
NCT Number NCT04506151
Lead Sponsor University of Illinois at Chicago
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Type 1 Diabetes
Enrollment 144 participants
Start Date 2021-01-19
Primary Completion 2024-12-21 (estimated)
Study Completion 2025-12-21 (estimated)
Updated on ClinicalTrials.gov 2026-08-27