Type 2 DiabetesDOTTNCT01901055

Diabetes-Obstructive Sleep Apnea Treatment Trial

A study testing CPAP and Diabetes Education in people with Type 2 Diabetes and Obstructive Sleep Apnea, run by Eileen R. Chasens at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes, Obstructive Sleep Apnea
What is being tested?: CPAP and Diabetes Education
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 98 participants
Where: 4 sitesUnited States
Study dates: 13 Feb 2014to 8 May 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Suboptimal glucose control (A1C ≥ 6.5%)
Moderate-to-severe obstructive sleep apnea (apnea + hypopnea index >= 10/hour)
age 18 years and older

Who cannot join

Poor glucose control (A1C > 11)
Type 1 or gestational diabetes
Sleep duration < 4 hrs
Acute medical or surgical conditions or hospitalization ≤ 3 months
Oxygen or bi-level PAP required
Prior CPAP or persons in household with CPAP
Employed in safety sensitive job
Pregnant

Trial locations and contacts

4 sites in 1 country.

United States4 sites

John D. Dingell VAMC
Detroit, Michigan, 48201
West Virginia University
Morgantown, West Virginia, 26506
Pittsburgh Veterans Administration Medical Center
Pittsburgh, Pennsylvania, 15240
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261

Other trials in United States

About this study

Official title: The Effect of Treatment of Obstructive Sleep Apnea on Diabetes Self Management and Glycemic Control

Diabetes self-management is important to help adults with type 2 diabetes achieve glucose control. Obstructive sleep apnea often co-exists with type 2 diabetes and may act as a barrier to diabetes self-management and glucose control. We will examine if treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP), combined with diabetes education, results in improved diabetes self-management and glucose control.

Read the detailed description

While diabetes self-management has been improved and refined over the last 30 years, many persons with T2DM continue to have difficulty in achieving glycemic goals. Obstructive sleep apnea (OSA) has a high prevalence among adults with type 2 diabetes (T2DM) and is associated with excessive daytime sleepiness, impaired mood, decreased vigilance, and reduced functional outcomes. The degree that OSA affects diabetes self-management, a known determinant of glycemic control, remains unstudied.

The most effective treatment for OSA, continuous positive airway pressure (CPAP), results in improved self-reported daytime functioning. However, the effect of CPAP treatment on reception of diabetes education remains unknown. The underlying premise of the proposed study from this new investigator is that OSA hinders diabetes self-management in adults with T2DM.

Our goal is to improve understanding of the effect of OSA on diabetes self-management and to determine the efficacy of CPAP treatment in improving diabetes outcomes in adults treated with CPAP compared to those on sham-CPAP. Expanding our understanding of the effect of sleep disturbances on diabetes self-management may lead to improved guidelines for screening and treatment of OSA in the increasingly large portion of the population with diabetes

Conditions: Type 2 Diabetes, Obstructive Sleep Apnea
Being tested: CPAP, Sham-CPAP, Diabetes Education
Keywords: sleep apnea, diabetes
Medical subject headings: Diabetes Mellitus, Type 2, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CPAPDevice
Also called Continuous Positive Airway Pressure
CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
Sham-CPAPDevice
Also called Sham Continuous Positive Airway Pressure
Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
Diabetes EducationBehavioural
Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)

Study groups in NCT01901055
Study group	Role	What they receive
Active CPAP treatment	Experimental	Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) Receives: Device: CPAP; Behavioral: Diabetes Education
Sham-CPAP	Placebo comparator	Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. Receives: Device: CPAP; Device: Sham-CPAP; Behavioral: Diabetes Education

What is being measured

The primary outcome is the main question the study is designed to answer.

HbA1C Level
Glycated hemoglobin test that estimates the blood glucose level over last 2 to 3 months. Higher scores indicate worse diabetes control.
Measured: baseline, 6 weeks, 12 weeks

Secondary outcomes (10)

Fructosamine Level
Measurement of glucose in plasma that estimates the blood glucose level over last 10 days to 3 weeks. The normal range is from 221.00 to 451.00.
Measured: baseline, 6 weeks, 12 weeks
Diabetes Diet Adherence
Diabetes Diet Adherence score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that was adherent to diabetes diet, range from minimum=0 days to maximum=7 days; higher number indicates better adherence to diabetes diet
Measured: baseline, 6 weeks, 12 weeks
Diabetes Knowledge
Score on the Diabetes Knowledge Test. Scores range minimum=0 to maximum=100, higher scores indicate higher knowledge (this measure only done at 12 weeks)
Measured: baseline,12 weeks only
Self-Monitoring of Blood Glucose (SMBG)
SMBG score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that SMBG was done, range from 0 days to 7 days; higher number indicates better SMBG
Measured: baseline, 6 weeks, 12 weeks
Steps Walked
Average number of steps walked daily; measured by BodyMedia Armband; higher numbers indicate more steps walked. The range is from 397.83 to 16839.00.
Measured: baseline, 6 weeks, 12 weeks
Self-Monitoring of Foot Care
Foot Care score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that foot care was done, range from 0 days to 7 days; higher number indicates better adherence to foot care
Measured: baseline, 6 weeks, 12 weeks
Diabetes-Related Distress
Score of the Problem Areas in Diabetes (PAID) Questionnaire; scores range from 0-100, higher scores indicate worse diabetes-related distress.
Measured: baseline, 6 weeks, 12 weeks
Sleep Quality
Sleep Quality is measured by the Pittsburgh Sleep Quality Index (PSQI) - Higher scores indicate worse sleep quality. The potential range is from 0 to 27 with higher scores indicating worse sleep quality.
Measured: baseline, 6 weeks, 12 weeks
Mood
Mood impairment measured by the Profile of Mood States (POMS) total score; potential scores range from 0 to 60; higher scores indicate worse mood.
Measured: baseline, 6 weeks, 12 weeks
Vigilance
Ability to maintain attention (i.e. vigilance); Measured by the Psychomotor Vigilance Test primary metric being transformed lapses (i.e. when person does not respond to a visual stimuli in a reaction time test). Normal values are <=2 lapses within the 10 minute test. Higher scores indicate worse vigilance.
Measured: Administered during diabetes education sessions done within the first 6 weeks of study; baseline, approximately 3 weeks after starting CPAP, and at the 2nd diabetes education session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Feb 20148 May 2019

First posted17 Jul 2013 (estimated)
Study start13 Feb 2014
Primary completion8 May 2019
Study completion8 May 2019

Why it stopped: The study did not reach 50% of the proposed sample size. Recruitment slow because persons not interested in being randomized to a sham-control CPAP device or not CPAP naïve.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies 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
Model description: Parallel was a one-way cross over after 12 weeks with persons originally in the sham group being titrated onto active CPAP.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01901055
Sponsor's protocol ID: 5R01DK096028-02
Acronym: DOTT
Status last verified: Aug 2021
First submitted: 10 Jul 2013
Last updated: 16 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Imes CC, Bizhanova Z, Sereika SM, Korytkowski MT, Atwood CW Jr, Burke LE, Kariuki J, Morris JL, Stansbury R, Strollo PJ Jr, Chasens ER. Metabolic outcomes in adults with type 2 diabetes and sleep disorders. Sleep Breath. 2022 Mar;26(1):339-346. doi: 10.1007/s11325-021-02408-x. Epub 2021 Jun 9.
PubMed 34105104
Chasens ER, Atwood CW, Burke LE, Korytkowski M, Stansbury R, Strollo PJ, Sereika SM. Diabetes sleep treatment trial: Premise, design, and methodology. Contemp Clin Trials. 2019 Jan;76:104-111. doi: 10.1016/j.cct.2018.11.014. Epub 2018 Dec 2.
PubMed 30517889

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Treatment of Obstructive Sleep Apnea on Diabetes Self Management and Glycemic Control
ClinicalTrials.gov ID: NCT01901055
Acronym / sponsor ID: DOTT / 5R01DK096028-02
Conditions: Type 2 Diabetes, Obstructive Sleep Apnea
Keywords: sleep apnea, diabetes
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study did not reach 50% of the proposed sample size. Recruitment slow because persons not interested in being randomized to a sham-control CPAP device or not CPAP naïve.
Enrolment: 98 participants (actual)
Lead sponsor: Eileen R. ChasensUniversity, hospital or other
Study start: 13 Feb 2014 (actual)
Primary completion: 8 May 2019 (actual)
Study completion: 8 May 2019 (actual)
First posted: 17 Jul 2013 (estimated)
Results: Posted 13 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Parallel was a one-way cross over after 12 weeks with persons originally in the sham group being titrated onto active CPAP.

Arm	Type	Receives
Active CPAP treatment	Experimental	Device: CPAP, Behavioral: Diabetes EducationTreatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
Sham-CPAP	Placebo comparator	Device: CPAP, Device: Sham-CPAP, Behavioral: Diabetes EducationDevice that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Suboptimal glucose control (A1C ≥ 6.5%)
Moderate-to-severe obstructive sleep apnea (apnea + hypopnea index >= 10/hour)
age 18 years and older

Key exclusion criteria (8 listed)

Poor glucose control (A1C > 11)
Type 1 or gestational diabetes
Sleep duration < 4 hrs
Acute medical or surgical conditions or hospitalization ≤ 3 months
Oxygen or bi-level PAP required

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
CPAPAlso: Continuous Positive Airway PressureCPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).	Device	Active CPAP treatment, Sham-CPAP
Sham-CPAPAlso: Sham Continuous Positive Airway PressureSham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).	Device	Sham-CPAP
Diabetes EducationDiabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)	Behavioural	Active CPAP treatment, Sham-CPAP

Primary outcome

HbA1C Level
Time frame: baseline, 6 weeks, 12 weeks
Glycated hemoglobin test that estimates the blood glucose level over last 2 to 3 months. Higher scores indicate worse diabetes control.

10 secondary outcomes

Fructosamine Level
Time frame: baseline, 6 weeks, 12 weeks
Diabetes Diet Adherence
Time frame: baseline, 6 weeks, 12 weeks
Diabetes Knowledge
Time frame: baseline,12 weeks only
Self-Monitoring of Blood Glucose (SMBG)
Time frame: baseline, 6 weeks, 12 weeks
Steps Walked
Time frame: baseline, 6 weeks, 12 weeks
Self-Monitoring of Foot Care
Time frame: baseline, 6 weeks, 12 weeks
Diabetes-Related Distress
Time frame: baseline, 6 weeks, 12 weeks
Sleep Quality
Time frame: baseline, 6 weeks, 12 weeks
Mood
Time frame: baseline, 6 weeks, 12 weeks
Vigilance
Time frame: Administered during diabetes education sessions done within the first 6 weeks of study; baseline, approximately 3 weeks after starting CPAP, and at the 2nd diabetes education session

Results and safety

Results posted to the registry on 13 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active CPAP Treatment	49	48
Sham-CPAP	49	47

Primary outcome: HbA1C Level

Time frame: baseline, 6 weeks, 12 weeks. Mean (Standard Error). Unit: % of glycated hemoglobin in the blood

Measure	Active CPAP Treatment n = 49	Sham-CPAP Treatment n = 49
Baseline	7.73 (0.13)	8.04 (0.13)
6-week	7.49 (0.17)	820 (0.17)
12-week	7.46 (0.15)	7.80 (0.16)

Active CPAP Treatment vs Sham-CPAP Treatment: Mean Difference (Net): -0.32 (95% CI -0.68 to 0.04), p = 0.017, Mixed Models Analysis

Population analysed: All randomized participants were analyzed (the intention to treat method).

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Until study completion, up to 36 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active CPAP Treatment	1 of 49 (2%)	0 of 49 (0%)	0 of 49
Sham-CPAP	1 of 49 (2%)	2 of 49 (4.1%)	0 of 49
Active CPAP Following Sham-CPAP	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): Recruitment was negatively affected by a large number of persons screened who were ineligible because of either their, or a family member, having prior CPAP treatment. Recruitment was also affected by persons who did not want the possibility of being randomized to be on a sham-CPAP device for 12 weeks.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34105104Imes CC, Bizhanova Z, Sereika SM, Korytkowski MT, Atwood CW Jr, Burke LE, Kariuki J, Morris JL, Stansbury R, Strollo PJ Jr, Chasens ER. Metabolic outcomes in adults with type 2 diabetes and sleep disorders. Sleep Breath. 2022 Mar;26(1):339-346. doi: 10.1007/s11325-021-02408-x. Epub 2021 Jun 9.
Derived from this study: PubMed 30517889Chasens ER, Atwood CW, Burke LE, Korytkowski M, Stansbury R, Strollo PJ, Sereika SM. Diabetes sleep treatment trial: Premise, design, and methodology. Contemp Clin Trials. 2019 Jan;76:104-111. doi: 10.1016/j.cct.2018.11.014. Epub 2018 Dec 2.
Individual participant dataSharing planned: No

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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.

Eileen R. Chasens, PhD principal investigator

University of Pittsburgh

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CPAP and Diabetes Education in people with Type 2 Diabetes and Obstructive Sleep Apnea, run by Eileen R. Chasens at 4 sites 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 13 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

HbA1C Level (time frame: baseline, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01901055, which also lists 2 linked publications.

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 16 Aug 2021.