NCT02316665

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2014

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

September 22, 2014

Last Update Submit

January 5, 2016

Conditions

Type 1 DiabetesSleep Apnea Syndrome

Keywords

Type 1 diabetesSleep apnea syndromeNocturnal glycemiaContinuous glucose monitoring systemContinuous positive airway pressureSleep habits

Outcome Measures

Primary Outcomes (1)

  • change in mean nocturnal glycemia

    Measured from continuous glycemic monitoring system

    3 months

Secondary Outcomes (9)

  • Change in blood pressure

    3 months

  • Change in the variability of nocturnal glycemia

    3months

  • Change in HbA1c

    3 months

  • Changes in sleep duration after intervention

    3 months

  • Change in mean systolic blood pressure after intervention

    3 months

  • +4 more secondary outcomes

Study Arms (2)

continuous positive airway pressure

EXPERIMENTAL

Patients will receive continuous positive airway pressure during three months

Device: continuous positive airway pressure

Sham-continuous positive airway pressure

SHAM COMPARATOR

Patients will receive sham-continuous positive airway pressure during 3 months

Device: Sham-continuous positive airway pressure

Interventions

continuous positive airway pressureDEVICE

continuous positive airway pressure treatment during three months with adherence recording

continuous positive airway pressure
Sham-continuous positive airway pressureDEVICE

Sham-continuous positive airway pressure during three months with adherence recording

Sham-continuous positive airway pressure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with type 1 diabetes

You may not qualify if:

  • Pregnant women
  • Patient with acute metabolic disorders during the past three months
  • Shift workers
  • Institutionalized patient
  • Enteral and parenteral nutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble University hospital

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Jean-Louis Pépin, MD PhD

    HP2 INSERM U1042 laboratory, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2014

First Posted

December 15, 2014

Study Start

April 1, 2013

Primary Completion

October 1, 2014

Study Completion

June 1, 2015

Last Updated

January 6, 2016

Record last verified: 2016-01

Locations

FR(1)