Type 1 DiabetesDIADEMENCT02316665
Effect of Sleep Apnea Treatment on Type 1 Diabetes
A study testing continuous positive airway pressure in people with Type 1 Diabetes and Sleep Apnea Syndrome, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Hypothesis: To address the role of continuous positive airway pressure (CPAP)on nocturnal glycemia in patients having type 1 diabetes and sleep apnea syndrome. Investigators make the hypothesis that sleep apnea syndrome impacts nocturnal glycemia in type 1 diabetic patients and that continuous positive airway pressure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Sleep Apnea Syndrome
- What is being tested?
- continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Jun 2015
- 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
- Adult patients with type 1 diabetes
Who cannot join
- Pregnant women
- Patient with acute metabolic disorders during the past three months
- Shift workers
- Institutionalized patient
- Enteral and parenteral nutrition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Continuous Positive Airway Pressure Treatment on Nocturnal Glycemia of Patients Having Type 1 Diabetes and Sleep Apnea Syndrome: a Randomized Controlled Trial
Hypothesis: To address the role of continuous positive airway pressure (CPAP)on nocturnal glycemia in patients having type 1 diabetes and sleep apnea syndrome.
Investigators make the hypothesis that sleep apnea syndrome impacts nocturnal glycemia in type 1 diabetic patients and that continuous positive airway pressure treatment will permit to improve the nocturnal glycemic profile.
Read more
Study design: Adult patients with type 1 diabetes will be recruited for an extensive study of sleep habits and assessment of sleep breathing disorders. When patients will present with severe sleep apnea syndrome (apnea-hypopnea index above 30 events/hour) and insufficient glycemic control (HbA1c > 7.5%), they will be randomized in continuous positive airway pressure treatment or sham-continuous positive airway pressure treatment group for three months.
Main outcome: Nocturnal glycemic control will be assessed for 5 days before and after three months of the allocated treatment.
Read the detailed description
Quality of clinical study procedures will be checked by on-site audit.
Patient self-reported past medical history will be checked by reviewing medical records.
Paper case report forms will be used.
For the baseline extensive study of sleep habits, the following data are recorded:
- Self-reported sleep diary (7 days)
- Actimetric device (7 days)
- Munich Chronotype Questionnaire
- 24h-dietary recall
- Salivary collections every 30 minutes between 7:30 pm and 22:00 pm on one night to address the dim light melatonin onset.
- Other questionnaires: Job strain questionnaire, EPICES (precarity questionnaire) and DQOL (diabetes related quality of life)
- Nocturnal oxymetry
Blood measurements: HbA1c, lipidic profile, microalbuminuria, creatinin
After baseline assessment, patients having an abnormal nocturnal oximetry will be explored by polysomnography in order to detect a sleep apnea syndrome.
Investigators anticipate, based on a previous pilot study of our group ("Borel" Diab Med 2010), that 30% of screened patients will present with sleep apnea.
If patients present with severe sleep apnea (IAH > 30 events/hour) and HbA1c > 7.5%, they will be randomized for the intervention.
Sample size: based on a previous study by "Pallayova" et al. in patients having type 2 diabetes, investigators anticipate a difference between groups of 1.3 (SD 2.07) for the mean nocturnal glycemia. For a alpha threshold of 5% and a study power of 80%, the study should include 32 patients in each group. Taking in account a possible 25% of dropout the study will need to include 40 patients by randomized arm to demonstrate an effect.
Statistical analysis: An intention-to-treat analysis will be performed. Missing data for the continuous positive airway pressure group will be replaced by the median value at three-month of the sham-continuous positive airway pressure group and reciprocally.
In a second analysis, a per-protocol analysis will be performed limited to patients having completed their treatment in allocated group and having an adherence to continuous positive airway pressure or sham-continuous positive airway pressure treatment for more than 4-hours a night.
Normality of data will be checked by Kurtosis and Skewness tests. The significance level will be set at 5%.
- Conditions
- Type 1 Diabetes, Sleep Apnea Syndrome
- Being tested
- continuous positive airway pressure, Sham-continuous positive airway pressure
- Keywords
- Type 1 diabetes, Sleep apnea syndrome, Nocturnal glycemia, Continuous glucose monitoring system, Continuous positive airway pressure, Sleep habits
- Medical subject headings
- Diabetes Mellitus, Type 1, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressureDevice
continuous positive airway pressure treatment during three months with adherence recording
Sham-continuous positive airway pressureDevice
Sham-continuous positive airway pressure during three months with adherence recording
| Study group | Role | What they receive |
|---|---|---|
| continuous positive airway pressure | Experimental | Patients will receive continuous positive airway pressure during three months Receives: Device: continuous positive airway pressure |
| Sham-continuous positive airway pressure | Sham comparator | Patients will receive sham-continuous positive airway pressure during 3 months Receives: Device: Sham-continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in mean nocturnal glycemia
Measured from continuous glycemic monitoring system
Measured: 3 months
Secondary outcomes (9)
Change in blood pressure
24h ambulatory blood pressure monitoring
Measured: 3 months
Change in the variability of nocturnal glycemia
Measured on nighttime recording of continuous glycemic monitoring system
Measured: 3months
Change in HbA1c
Measured: 3 months
Changes in sleep duration after intervention
Actimetry
Measured: 3 months
Change in mean systolic blood pressure after intervention
Self-monitoring blood pressure and heart rate device, at home
Measured: 3 months
Chang in sleep timing after intervention
Actimetry
Measured: 3 months
Change in daily activity after intervention
Actimetry
Measured: 3 months
Change in mean diastolic blood pressure after intervention
Self-monitoring blood pressure and heart rate device, at home
Measured: 3 months
Change in mean heart rate after intervention
Self-monitoring blood pressure and heart rate device, at home
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startApr 2013
- Primary completionOct 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Société francophone de pneumologie de langue francaise, ResMed
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Pépin, MD PhD, Principal investigator, HP2 INSERM U1042 laboratory, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316665
- Sponsor's protocol ID
- 2012-A006336-40
- Acronym
- DIADEME
- Status last verified
- Jan 2016
- First submitted
- 22 Sep 2014
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Positive Airway Pressure Treatment on Nocturnal Glycemia of Patients Having Type 1 Diabetes and Sleep Apnea Syndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02316665
- Acronym / sponsor ID
- DIADEME / 2012-A006336-40
- Conditions
- Type 1 Diabetes, Sleep Apnea Syndrome
- Keywords
- Type 1 diabetes, Sleep apnea syndrome, Nocturnal glycemia, Continuous glucose monitoring system, Continuous positive airway pressure, Sleep habits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Société francophone de pneumologie de langue francaise, ResMed
- Study start
- Apr 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 Dec 2014 (estimated)
- 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.
Hypothesis: To address the role of continuous positive airway pressure (CPAP)on nocturnal glycemia in patients having type 1 diabetes and sleep apnea syndrome.
Investigators make the hypothesis that sleep apnea syndrome impacts nocturnal glycemia in type 1 diabetic patients and that continuous positive airway pressure treatment will permit to improve the nocturnal glycemic profile.
Study design: Adult patients with type 1 diabetes will be recruited for an extensive study of sleep habits and assessment of sleep breathing disorders. When patients will present with severe sleep apnea syndrome (apnea-hypopnea index above 30 events/hour) and insufficient glycemic control (HbA1c > 7.5%), they will be randomized in continuous positive airway pressure treatment or sham-continuous positive airway pressure treatment group for three months.
Main outcome: Nocturnal glycemic control will be assessed for 5 days before and after three months of the allocated treatment.
Detailed description
Quality of clinical study procedures will be checked by on-site audit.
Patient self-reported past medical history will be checked by reviewing medical records.
Paper case report forms will be used.
For the baseline extensive study of sleep habits, the following data are recorded:
- Self-reported sleep diary (7 days)
- Actimetric device (7 days)
- Munich Chronotype Questionnaire
- 24h-dietary recall
- Salivary collections every 30 minutes between 7:30 pm and 22:00 pm on one night to address the dim light melatonin onset.
- Other questionnaires: Job strain questionnaire, EPICES (precarity questionnaire) and DQOL (diabetes related quality of life)
- Nocturnal oxymetry
Blood measurements: HbA1c, lipidic profile, microalbuminuria, creatinin
After baseline assessment, patients having an abnormal nocturnal oximetry will be explored by polysomnography in order to detect a sleep apnea syndrome.
Investigators anticipate, based on a previous pilot study of our group ("Borel" Diab Med 2010), that 30% of screened patients will present with sleep apnea.
If patients present with severe sleep apnea (IAH > 30 events/hour) and HbA1c > 7.5%, they will be randomized for the intervention.
Sample size: based on a previous study by "Pallayova" et al. in patients having type 2 diabetes, investigators anticipate a difference between groups of 1.3 (SD 2.07) for the mean nocturnal glycemia. For a alpha threshold of 5% and a study power of 80%, the study should include 32 patients in each group. Taking in account a possible 25% of dropout the study will need to include 40 patients by randomized arm to demonstrate an effect.
Statistical analysis: An intention-to-treat analysis will be performed. Missing data for the continuous positive airway pressure group will be replaced by the median value at three-month of the sham-continuous positive airway pressure group and reciprocally.
In a second analysis, a per-protocol analysis will be performed limited to patients having completed their treatment in allocated group and having an adherence to continuous positive airway pressure or sham-continuous positive airway pressure treatment for more than 4-hours a night.
Normality of data will be checked by Kurtosis and Skewness tests. The significance level will be set at 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous positive airway pressure | Experimental | Device: continuous positive airway pressurePatients will receive continuous positive airway pressure during three months |
| Sham-continuous positive airway pressure | Sham comparator | Device: Sham-continuous positive airway pressurePatients will receive sham-continuous positive airway pressure during 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with type 1 diabetes
Key exclusion criteria (5 listed)
- Pregnant women
- Patient with acute metabolic disorders during the past three months
- Shift workers
- Institutionalized patient
- Enteral and parenteral nutrition
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 |
|---|---|---|
| continuous positive airway pressurecontinuous positive airway pressure treatment during three months with adherence recording | Device | continuous positive airway pressure |
| Sham-continuous positive airway pressureSham-continuous positive airway pressure during three months with adherence recording | Device | Sham-continuous positive airway pressure |
Primary outcome
change in mean nocturnal glycemia
Time frame: 3 months
Measured from continuous glycemic monitoring system
9 secondary outcomes
Change in blood pressure
Time frame: 3 months
Change in the variability of nocturnal glycemia
Time frame: 3months
Change in HbA1c
Time frame: 3 months
Changes in sleep duration after intervention
Time frame: 3 months
Change in mean systolic blood pressure after intervention
Time frame: 3 months
Chang in sleep timing after intervention
Time frame: 3 months
Change in daily activity after intervention
Time frame: 3 months
Change in mean diastolic blood pressure after intervention
Time frame: 3 months
Change in mean heart rate after intervention
Time frame: 3 months
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 6 Jan 2016.
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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.
Jean-Louis Pépin, MD PhD principal investigator
HP2 INSERM U1042 laboratory, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous positive airway pressure in people with Type 1 Diabetes and Sleep Apnea Syndrome, run by University Hospital, Grenoble at 1 site in France.
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 1 inclusion and 5 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 6 Jan 2016. 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 France. 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?
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?
change in mean nocturnal glycemia (time frame: 3 months). 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 6 Jan 2016.