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OpenTrials
Completed

NCT Number: NCT04806685

Diabetes Education and A1c Study

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michigan State University

East Lansing, Michigan, 48824, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sleep Education

Behavioral

Medical nutrition therapy plus behavior-based sleep education intervention

Diet only

Behavioral

No sleep education

Primary outcomes

  1. Hemoglobin A1c

    Time frame: 12 weeks

    Lab value

Secondary outcomes

  1. Body mass index

    Time frame: 12 weeks

    Calculated from height and weight

  2. Sleep duration

    Time frame: 12 weeks

    FitBit outcomes data

  3. Sleep quality

    Time frame: 12 weeks

    Pittsburgh Sleep Quality Index

  4. Diabetes self-care

    Time frame: 12 weeks

    Diabetes Self-Management Questionnaire

  5. Epworth Sleepiness Scale

    Time frame: 12 weeks

    Validated survey measuring excessive daytime sleepiness

  6. Insomnia Severity Index

    Time frame: 12 weeks

    Validated survey measuring insomnia symptoms

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • Blue Cross Blue Shield

Registry information

Acronym: DEA1c

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 19, 2021
Registry last updated
Dec 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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