Diabetes Education and A1c Study (DEA1c)

Michigan State University

Status: Completed

Conditions: Diabetes Mellitus, Type 2; Sleep

Treatments: Behavioral: Diet only; Behavioral: Sleep education

Study type: Interventional

Funder types: Other

Identifiers

NCT04806685

STUDY00005457

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups

Intervention

Experimental group

Description:

Diet therapy plus sleep education

Treatment:

Behavioral: Sleep education

Control

Other group

Description:

Diet therapy

Treatment:

Behavioral: Diet only