Diabetes Mellitus, Type 2DEA1cNCT04806685
Diabetes Education and A1c Study
A study testing Sleep education and Diet only in people with Diabetes Mellitus, Type 2 and Sleep, run by Michigan State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Sleep
- What is being tested?
- Sleep education and Diet only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Michigan State University
East Lansing, Michigan, 48824
About this 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.
- Conditions
- Diabetes Mellitus, Type 2, Sleep
- Being tested
- Sleep education, Diet only
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep educationBehavioural
Medical nutrition therapy plus behavior-based sleep education intervention
Diet onlyBehavioural
No sleep education
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Diet therapy plus sleep education Receives: Behavioral: Sleep education |
| Control | Other | Diet therapy Receives: Behavioral: Diet only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Lab value
Measured: 12 weeks
Secondary outcomes (6)
Body mass index
Calculated from height and weight
Measured: 12 weeks
Sleep duration
FitBit outcomes data
Measured: 12 weeks
Sleep quality
Pittsburgh Sleep Quality Index
Measured: 12 weeks
Diabetes self-care
Diabetes Self-Management Questionnaire
Measured: 12 weeks
Epworth Sleepiness Scale
Validated survey measuring excessive daytime sleepiness
Measured: 12 weeks
Insomnia Severity Index
Validated survey measuring insomnia symptoms
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start15 Mar 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield
- Responsible party
- Principal investigator, Robin Tucker, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806685
- Sponsor's protocol ID
- STUDY00005457
- Acronym
- DEA1c
- Status last verified
- Dec 2022
- First submitted
- 15 Mar 2021
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Education and A1c Study
- ClinicalTrials.gov ID
- NCT04806685
- Acronym / sponsor ID
- DEA1c / STUDY00005457
- Conditions
- Diabetes Mellitus, Type 2, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Sleep educationDiet therapy plus sleep education |
| Control | Other | Behavioral: Diet onlyDiet therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep educationMedical nutrition therapy plus behavior-based sleep education intervention | Behavioural | Intervention |
| Diet onlyNo sleep education | Behavioural | Control |
Primary outcome
Hemoglobin A1c
Time frame: 12 weeks
Lab value
6 secondary outcomes
Body mass index
Time frame: 12 weeks
Sleep duration
Time frame: 12 weeks
Sleep quality
Time frame: 12 weeks
Diabetes self-care
Time frame: 12 weeks
Epworth Sleepiness Scale
Time frame: 12 weeks
Insomnia Severity Index
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep education and Diet only in people with Diabetes Mellitus, Type 2 and Sleep, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022; AzTrials last refreshed its copy on 2 Nov 2026.