Diabetes Education and A1c Study

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Sleep
• Interventions: Behavioral: Diet only; Behavioral: Sleep education

• Registration Number: NCT04806685
• Lead Sponsor: Michigan State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-15
• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-19
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-02
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Diet only	Diet therapy
Intervention	Sleep education	Diet therapy plus sleep education

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	12 weeks	Lab value

Secondary Outcome Measures

Name	Time	Method
Body mass index	12 weeks	Calculated from height and weight
Sleep duration	12 weeks	FitBit outcomes data
Sleep quality	12 weeks	Pittsburgh Sleep Quality Index
Epworth Sleepiness Scale	12 weeks	Validated survey measuring excessive daytime sleepiness
Diabetes self-care	12 weeks	Diabetes Self-Management Questionnaire
Insomnia Severity Index	12 weeks	Validated survey measuring insomnia symptoms

Trial Locations

Locations (1)

Michigan State University; 🇺🇸 East Lansing, Michigan, United States