Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT07091318
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CBTi for the Treatment of Insomnia in Type 1 Diabetes
Sponsor:
University of Illinois at Chicago
Organization:
Study Overview
Official Title:
CBTi for the Treatment of Insomnia in Type 1 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to learn if treating insomnia with a therapy intervention in people with type 1 diabetes will help to better control sugar levels, sleep, and quality of life. The questions this study aims to answer include:
Will this intervention help the insomnia symptoms? Will obtaining better sleep aid in the control of diabetes through measures like sugar levels? Will the intervention help with quality of life factors like mood and fatigue?
Researchers will compare participants receiving the therapy intervention for sleep with those in the "healthy living" intervention to see if the outcomes are different based on the treatment.
Participants in the therapy intervention group will:
* meet virtually with a therapist for 8 sessions via Zoom. Once a week for the first 4 weeks and then every other week for the last 4 sessions.
Participants in the healthy living group will:
* receive weekly health education emails
* receive brief weekly calls from a coach to answer any questions
Participants, regardless of intervention, over the 12 week study period will:
* monitor their sleep for 2 weeks through a sleep-monitoring watch
* share their continuous glucose monitoring data throughout the study
* answer questionnaires prior to the intervention, halfway through the intervention and then after the intervention
* attend 3 in person office visits
Will this intervention help the insomnia symptoms? Will obtaining better sleep aid in the control of diabetes through measures like sugar levels? Will the intervention help with quality of life factors like mood and fatigue?
Researchers will compare participants receiving the therapy intervention for sleep with those in the "healthy living" intervention to see if the outcomes are different based on the treatment.
Participants in the therapy intervention group will:
* meet virtually with a therapist for 8 sessions via Zoom. Once a week for the first 4 weeks and then every other week for the last 4 sessions.
Participants in the healthy living group will:
* receive weekly health education emails
* receive brief weekly calls from a coach to answer any questions
Participants, regardless of intervention, over the 12 week study period will:
* monitor their sleep for 2 weeks through a sleep-monitoring watch
* share their continuous glucose monitoring data throughout the study
* answer questionnaires prior to the intervention, halfway through the intervention and then after the intervention
* attend 3 in person office visits
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: