Diabetes Mellitus, Type 1APT1NCT03506022
Prevalence of Sleep Apnea Syndrome in Patients With Type 1 Diabetes
A study testing standard polysomnography in people with Diabetes Mellitus, Type 1, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Obstructive sleep apnea (OSA) and Type 2 diabetes are two frequent diseases that occur in adult population. The prevalence of OSA is higher in people with Type 2 diabetes compared with the general population7 ; in addition, the OSA syndrome is almost assessed in obese type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- standard polysomnography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2018to 11 Apr 2019
- 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
- All patients over 18 years
- with type 1 mellitus diabetes
Who cannot join
- Type-free diabetes (type 1 slow),
- Age <18 years
- A poor compliance with the follow-up (meetings unfulfilled without justification).
- All patients with known sleep disorders (OSA, narcolepsy, idiopathic hypersomnia).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Sleep Apnea Syndrome in Patients With Type 1 Diabetes (APT1)
Obstructive sleep apnea (OSA) and Type 2 diabetes are two frequent diseases that occur in adult population. The prevalence of OSA is higher in people with Type 2 diabetes compared with the general population7 ; in addition, the OSA syndrome is almost assessed in obese type 2 diabetes. The relationship between OSA and Type 2 diabetes has been well characterized: the OSA can contribute to increased insulin resistance or glucose intolerance; and, diabetes may worsen sleep-disordered breathing because of autonomic neuropathy8,9. The main link between OSA and Type 2 diabetes is central obesity, which triggers glucose intolerance/insulin resistance and is also an independent risk factor for OSA. Type 1 diabetes is generally not related to obesity; however, sleep-disordered breathing in these patients was described in few reports early as 1985 by pioneers such as Guilleminault5 and the prevalence of OSA is estimated at range 10 to 40% in type 1 diabetes patients. Few studies had evaluated the prevalence of sleep disorders in particular the sleep apnea syndrome in patients with type 1 diabetes and even less their influence on the glycemic control.
This study will take place at the CHU of Amiens-Picardie during a one-night hospitalization. The investigators will study in 44 type 1 diabetes mellitus (IAH apnea hypopnea index ≥15) who underwent polysomnography and continuous glucose monitoring of blood glucose
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- standard polysomnography
- Keywords
- Sleep apnea syndrome, polysomnography and glucose monitoring continu glycemia (CGMS )
- 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.
standard polysomnographyOther
All participants were admitted in sleep laboratory and screened for one night of 8 hours employing standard polysomnography (Brainnet System - Medatec) parameters : electroencephalogram, electro-oculogram, electromyogram [chin], continuous nasal airflow body position, thoracic and abdominal strain gauges, haemoglobin oxygen saturation (SaO2) with an oximeter (Medatec) attached to finger. Blood pressure was measured in the evening during the physical examines, and then the CGMS recording startedpressure was measured in the evening during the physical examines, and then the CGMS recording started
| Study group | Role | What they receive |
|---|---|---|
| patients with type 1 mellitus diabetes | Other | All participants were admitted in sleep laboratory and screened for one night of 8 hours employing standard polysomnography (Brainnet System - Medatec) parameters Receives: Other: standard polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of obstructive sleep apnea syndrome confirmed by polysomnography an apnea hypopnea Index ≥ 15
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start12 Jan 2018
- Primary completion11 Apr 2019
- Study completion11 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients over 18 years with type 1 mellitus diabetes will be included. The exclusion criteria are type-free diabetes (type 1 slow), age \<18 years, a poor compliance with the follow-up (meetings unfulfilled without justification). All patients with known sleep disorders (OSA, narcolepsy, idiopathic hypersomnia).
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506022
- Sponsor's protocol ID
- PI2017_843_0019
- Acronym
- APT1
- Status last verified
- Nov 2025
- First submitted
- 13 Apr 2018
- Last updated
- 19 Nov 2025
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sleep Apnea Syndrome in Patients With Type 1 Diabetes (APT1)
- ClinicalTrials.gov ID
- NCT03506022
- Acronym / sponsor ID
- APT1 / PI2017_843_0019
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Sleep apnea syndrome, polysomnography and glucose monitoring continu glycemia (CGMS )
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 11 Apr 2019 (actual)
- First posted
- 23 Apr 2018 (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.
Obstructive sleep apnea (OSA) and Type 2 diabetes are two frequent diseases that occur in adult population. The prevalence of OSA is higher in people with Type 2 diabetes compared with the general population7 ; in addition, the OSA syndrome is almost assessed in obese type 2 diabetes. The relationship between OSA and Type 2 diabetes has been well characterized: the OSA can contribute to increased insulin resistance or glucose intolerance; and, diabetes may worsen sleep-disordered breathing because of autonomic neuropathy8,9. The main link between OSA and Type 2 diabetes is central obesity, which triggers glucose intolerance/insulin resistance and is also an independent risk factor for OSA. Type 1 diabetes is generally not related to obesity; however, sleep-disordered breathing in these patients was described in few reports early as 1985 by pioneers such as Guilleminault5 and the prevalence of OSA is estimated at range 10 to 40% in type 1 diabetes patients. Few studies had evaluated the prevalence of sleep disorders in particular the sleep apnea syndrome in patients with type 1 diabetes and even less their influence on the glycemic control.
This study will take place at the CHU of Amiens-Picardie during a one-night hospitalization. The investigators will study in 44 type 1 diabetes mellitus (IAH apnea hypopnea index ≥15) who underwent polysomnography and continuous glucose monitoring of blood glucose
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients over 18 years with type 1 mellitus diabetes will be included. The exclusion criteria are type-free diabetes (type 1 slow), age <18 years, a poor compliance with the follow-up (meetings unfulfilled without justification). All patients with known sleep disorders (OSA, narcolepsy, idiopathic hypersomnia).
| Arm | Type | Receives |
|---|---|---|
| patients with type 1 mellitus diabetes | Other | Other: standard polysomnographyAll participants were admitted in sleep laboratory and screened for one night of 8 hours employing standard polysomnography (Brainnet System - Medatec) parameters |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients over 18 years
- with type 1 mellitus diabetes
Key exclusion criteria (4 listed)
- Type-free diabetes (type 1 slow),
- Age <18 years
- A poor compliance with the follow-up (meetings unfulfilled without justification).
- All patients with known sleep disorders (OSA, narcolepsy, idiopathic hypersomnia).
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 |
|---|---|---|
| standard polysomnographyAll participants were admitted in sleep laboratory and screened for one night of 8 hours employing standard polysomnography (Brainnet System - Medatec) parameters : electroencephalogram, electro-oculogram, electromyogram [chin], continuous nasal airflow body position, thoracic and abdominal strain gauges, haemoglobin oxygen saturation (SaO2) with an oximeter (Medatec) attached to finger. Blood pressure was measured in the evening during the physical examines, and then the CGMS recording startedpressure was measured in the evening during the physical examines, and then the CGMS recording started | Other | patients with type 1 mellitus diabetes |
Primary outcome
Prevalence of obstructive sleep apnea syndrome confirmed by polysomnography an apnea hypopnea Index ≥ 15
Time frame: 3 month
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 19 Nov 2025.
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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 standard polysomnography in people with Diabetes Mellitus, Type 1, run by Centre Hospitalier Universitaire, Amiens 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 2 inclusion and 4 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 19 Nov 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 confirmed by polysomnography an apnea hypopnea Index ≥ 15 (time frame: 3 month). 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 19 Nov 2025.