Diabetes Education and A1c Study
DEA1c
1 other identifier
interventional
22
1 country
1
Brief Summary
Sleep problems are associated with poor blood glucose control, but current diabetes self-management programs do not include sleep education. This study will randomize participants into two groups: one that receives sleep education and one that does not. The researchers expect both groups to experience reductions in blood glucose. The researchers hypothesize that individuals who receive sleep education as part of their diabetes self-management training will experience greater improvements in blood glucose control, as measured by hemoglobin A1c, compared to the control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2021
CompletedStudy Start
First participant enrolled
March 15, 2021
CompletedFirst Posted
Study publicly available on registry
March 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedDecember 5, 2022
December 1, 2022
1.5 years
March 15, 2021
December 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c
Lab value
12 weeks
Secondary Outcomes (6)
Body mass index
12 weeks
Sleep duration
12 weeks
Sleep quality
12 weeks
Diabetes self-care
12 weeks
Epworth Sleepiness Scale
12 weeks
- +1 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALDiet therapy plus sleep education
Control
OTHERDiet therapy
Interventions
Medical nutrition therapy plus behavior-based sleep education intervention
Eligibility Criteria
You may qualify if:
- Individuals with a diagnosis of type 2 diabetes who are patients at the Michigan State University (MSU) Endocrinology clinic,
- a diagnosis of overweight or obesity (Body Mass Index greater than or equal to 25.0 kg/m2),
- the most recent hemoglobin A1c value greater than or equal to 7.5%, and
- the ability to attend online program sessions.
You may not qualify if:
- significant psychiatric disorders,
- advanced medical conditions that require alterations to the MNT for DM2, e.g., advanced chronic kidney disease, and
- an inability to follow recommendations due to cognitive deficits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Michigan State University
East Lansing, Michigan, 48824, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 15, 2021
First Posted
March 19, 2021
Study Start
March 15, 2021
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
December 5, 2022
Record last verified: 2022-12