Diabetes Education and A1c Study

NCT ID: NCT04806685

Last Updated: 2022-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2022-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Intervention

Diet therapy plus sleep education

Group Type EXPERIMENTAL

Sleep education

Intervention Type BEHAVIORAL

Medical nutrition therapy plus behavior-based sleep education intervention

Control

Diet therapy

Group Type OTHER

Diet only

Intervention Type BEHAVIORAL

No sleep education

Interventions

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Sleep education

Medical nutrition therapy plus behavior-based sleep education intervention

Intervention Type BEHAVIORAL

Diet only

No sleep education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Blue Cross Blue Shield Foundation of Michigan

UNKNOWN

Sponsor Role collaborator

Michigan State University

OTHER

Sponsor Role lead

Responsible Party

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Robin Tucker

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Michigan State University

East Lansing, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00005457

Identifier Type: -

Identifier Source: org_study_id

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