Type 1 DiabetesAT1HomeNCT02796534
Prevalence of Obstructive Sleep Apnea Syndrome in Type 1 Diabetic Patients Treated With Insulin Pump (At1Home)
An observational study of Type 1 Diabetes, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Patients with type 1 diabetes have poorer glycemic control that could lead to macrovascular or neuropathic complications; in addition to an optimal treatment, prevention of diabetes complications requires to control associated risk factors, such as hypertension or dyslipidemia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Diagnosis of sleep apnea by oxymetry
- How many people
- 825 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jul 2016to 27 Mar 2023
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 1 patients treated by Insulin Pump.
Who may be able to join
- Male or female aged 18 to 75 years
- Type 1 diabetic
- Treated on insulin therapy by external pump
- Take home monitoring as part of a usual care for insulin therapy by external pump
- Voluntary to participate in research with written informed consent
- Patient affiliated to the social security or similar regime
Who cannot join
- Privited person of liberty by judicial or administrative decision, person covered by legal protection (pregnant or lactating women, patients under guardianship) Article L1121-8
- In exclusion period of other studies
- Patient may, at the discretion of the investigator, not comply with the study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Patients with type 1 diabetes have poorer glycemic control that could lead to macrovascular or neuropathic complications; in addition to an optimal treatment, prevention of diabetes complications requires to control associated risk factors, such as hypertension or dyslipidemia. Sleep apnea syndrome is a public health problem due to its high prevalence and marked morbidity and mortality, one increasingly interesting aspect is its relationship with metabolic disorders, specifically diabetes.Obstructive sleep apnea syndrome seems to be underestimated in this population. In this context, it appears to be important to estimate the prevalence of sleep respiratory diseases in patients with type 1 diabetes.
- Conditions
- Type 1 Diabetes
- Being tested
- Diagnosis of sleep apnea by oxymetry
- Keywords
- Obstructive Sleep Apnea Syndrome
- Medical subject headings
- Diabetes Mellitus, Type 1, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of sleep apnea by oxymetryOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of obstructive sleep apnea syndrome by oxymetry, confirmed by polysomnography
Number of patients presenting an obstructive apnea syndrome
Measured: 2 years
Secondary outcomes (4)
Relationship between sleep apnea syndrome severity and micro/macro vascular complications of type 1 diabetes
Number and type of micro and macro vascular complications will be analysed from medical history and new events will be collected at each visit and validated by endocrinologist
Measured: 2 years
Relationship between sleep apnea syndrome severity and type 1 diabetes control
Results from regularly prescribed HbA1c analysis will be collected
Measured: 2 years
Compliance of the Continuous Positive Airway Pressure (CPAP) after 3 months of use in patients with type 1 diabetes treated for severe SAS.
Objective compliance to the CPAP treatment is daily recorded into the device and will be provided by home care provider
Measured: 2 years
Incidence of new cardiovascular events and changes in microangiopathic complications of diabetes patients depending on the presence of sleep apnea syndrome and to the adherence to CPAP treatment in case of sleep apnea syndrome treated
New events will be collected by asking the patients, after 1 year and 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study start28 Jul 2016
- Primary completion28 Jul 2018
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 825 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- VitalAire, ResMed
- Responsible party
- Sponsor
- Investigators
- Jean-Louis PEPIN, Md, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796534
- Sponsor's protocol ID
- 38RC14.199
- Acronym
- AT1Home
- Status last verified
- Dec 2025
- First submitted
- 23 May 2016
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pepin JL, Bailly S, Texereau JB, Sonnet E, Picard S, Verges B, Coffin Boutreux C, Arnault Ouary G, Kessler L, Guerci B, Anton Kuchly B, Fendri Gaied S, Cuperlier A, Voinot C, Derrien C, Dubois S, Lavergne F, Borel AL, Tamisier R, Benhamou PY. Prevalence of sleep apnoea in patients with type 1 diabetes and its association with comorbidities and diabetic complications: A French nationwide prospective study. Diabetes Obes Metab. 2023 Jun;25(6):1624-1631. doi: 10.1111/dom.15015. Epub 2023 Mar 3.
PubMed 36792920
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Obstructive Sleep Apnea Syndrome in Type 1 Diabetic Patients Treated With Insulin Pump (At1Home)
- ClinicalTrials.gov ID
- NCT02796534
- Acronym / sponsor ID
- AT1Home / 38RC14.199
- Conditions
- Type 1 Diabetes
- Keywords
- Obstructive Sleep Apnea Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 825 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- VitalAire, ResMed
- Study start
- 28 Jul 2016 (actual)
- Primary completion
- 28 Jul 2018 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 10 Jun 2016 (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.
Patients with type 1 diabetes have poorer glycemic control that could lead to macrovascular or neuropathic complications; in addition to an optimal treatment, prevention of diabetes complications requires to control associated risk factors, such as hypertension or dyslipidemia. Sleep apnea syndrome is a public health problem due to its high prevalence and marked morbidity and mortality, one increasingly interesting aspect is its relationship with metabolic disorders, specifically diabetes.Obstructive sleep apnea syndrome seems to be underestimated in this population. In this context, it appears to be important to estimate the prevalence of sleep respiratory diseases in patients with type 1 diabetes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 1 patients treated by Insulin Pump.
Key inclusion criteria (6 listed)
- Male or female aged 18 to 75 years
- Type 1 diabetic
- Treated on insulin therapy by external pump
- Take home monitoring as part of a usual care for insulin therapy by external pump
- Voluntary to participate in research with written informed consent
Key exclusion criteria (3 listed)
- Privited person of liberty by judicial or administrative decision, person covered by legal protection (pregnant or lactating women, patients under guardianship) Article L1121-8
- In exclusion period of other studies
- Patient may, at the discretion of the investigator, not comply with the study procedures
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 |
|---|---|---|
| Diagnosis of sleep apnea by oxymetry | Other | – |
Primary outcome
Prevalence of obstructive sleep apnea syndrome by oxymetry, confirmed by polysomnography
Time frame: 2 years
Number of patients presenting an obstructive apnea syndrome
4 secondary outcomes
Relationship between sleep apnea syndrome severity and micro/macro vascular complications of type 1 diabetes
Time frame: 2 years
Relationship between sleep apnea syndrome severity and type 1 diabetes control
Time frame: 2 years
Compliance of the Continuous Positive Airway Pressure (CPAP) after 3 months of use in patients with type 1 diabetes treated for severe SAS.
Time frame: 2 years
Incidence of new cardiovascular events and changes in microangiopathic complications of diabetes patients depending on the presence of sleep apnea syndrome and to the adherence to CPAP treatment in case of sleep apnea syndrome treated
Time frame: 2 years
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 29 Dec 2025.
- Results publication: PubMed 36792920Pepin JL, Bailly S, Texereau JB, Sonnet E, Picard S, Verges B, Coffin Boutreux C, Arnault Ouary G, Kessler L, Guerci B, Anton Kuchly B, Fendri Gaied S, Cuperlier A, Voinot C, Derrien C, Dubois S, Lavergne F, Borel AL, Tamisier R, Benhamou PY. Prevalence of sleep apnoea in patients with type 1 diabetes and its association with comorbidities and diabetic complications: A French nationwide prospective study. Diabetes Obes Metab. 2023 Jun;25(6):1624-1631. doi: 10.1111/dom.15015. Epub 2023 Mar 3.
- 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.
Jean-Louis PEPIN, Md, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, 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 6 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 29 Dec 2025. 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. 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?
Prevalence of obstructive sleep apnea syndrome by oxymetry, confirmed by polysomnography (time frame: 2 years). 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 NCT02796534, which also lists 1 linked publication.
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 29 Dec 2025.