Diabetes Education and A1c Study (DEA1c)

December 2, 2022 updated by: Robin Tucker, Michigan State University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Michigan State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Diet therapy plus sleep education
Behavioral: Sleep education
Medical nutrition therapy plus behavior-based sleep education intervention
Other: Control
Diet therapy
Behavioral: Diet only
No sleep education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c
Time Frame: 12 weeks
Lab value
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michigan State University

Collaborators

Blue Cross Blue Shield Foundation of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2021

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

March 15, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

December 5, 2022

Last Update Submitted That Met QC Criteria

December 2, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00005457 (Other Identifier: Emory University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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