Diabetes Education and A1c Study

Diabetes Mellitus, Type 2 Clinical Trial

— DEA1c  

Official title:

Diabetes Education and A1c Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04806685
• Other study ID #: STUDY00005457
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: December 2022
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Sleep

Intervention

Behavioral:
• Sleep education
Medical nutrition therapy plus behavior-based sleep education intervention
• Diet only
No sleep education

Locations

Country	Name	City	State
United States	Michigan State University	East Lansing	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michigan State University	Blue Cross Blue Shield Foundation of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	Lab value	12 weeks
Secondary	Body mass index	Calculated from height and weight	12 weeks
Secondary	Sleep duration	FitBit outcomes data	12 weeks
Secondary	Sleep quality	Pittsburgh Sleep Quality Index	12 weeks
Secondary	Diabetes self-care	Diabetes Self-Management Questionnaire	12 weeks
Secondary	Epworth Sleepiness Scale	Validated survey measuring excessive daytime sleepiness	12 weeks
Secondary	Insomnia Severity Index	Validated survey measuring insomnia symptoms	12 weeks