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Clinical Trials/NCT04806685
NCT04806685CompletedNot Applicable

Diabetes Education and A1c Study

Michigan State University2 sites in 1 country22 target enrollmentStarted: March 15, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
2
Primary Endpoint
Hemoglobin A1c
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Hemoglobin A1c

Time Frame: 12 weeks

Lab value

Secondary Outcomes

  • Body mass index(12 weeks)
  • Sleep duration(12 weeks)
  • Sleep quality(12 weeks)
  • Epworth Sleepiness Scale(12 weeks)
  • Diabetes self-care(12 weeks)
  • Insomnia Severity Index(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Robin Tucker

Assistant Professor

Michigan State University

Study Sites (2)

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