Type 1 DiabetesDIAPASOM2NCT01017965
Impact of Objective Sleep Duration on Blood Glucose Control in Type 1 Diabetes Adult Patients
An observational study of Type 1 Diabetes, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The objective of this study is to assess the impact of objective sleep duration on blood glucose control in type 1 diabetes adult patients. This study will also evaluate the impact of objective sleep duration on blood pressure over a 24-hour period and the impact of objective sleep duration on quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Actimeter + blood pressure monitoring
- Type of treatment
- Medical device
- How many people
- 79 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to Apr 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll type 1 diabetes patients who come for a consultation in Grenoble University Hospital.
Who may be able to join
- Patient affiliated to Social Security
- Written consent to participate to the study
- Ambulatory medical follow-up
- Patient with type 1 diabetes, defined by the criteria of the American Diabetes Association in 1997, stable (no ketoacidosis episode or hypoglycaemia with loss of consciousness requiring the intervention of a third person, during the previous month)
Who cannot join
- Underage patient, major patient under guardianship or protected by the Law
- Pregnant, parturient or breastfeeding woman
- Person with no freedom (prisoner), person hospitalized without consent and not protected by the Law
- Non-stabilized diabetes with at least one ketoacidosis episode or hypoglycaemia with loss of consciousness requiring the intervention of a third person, during the previous month.
- Bedridden person or person with mobility impairment.
- Patient already hospitalized at enrolment time
- Patient whose physical or psychological health could interfere with obtention of informed consent and compliance to the protocol (especially answers to the questionnaires)
- Terminally-ill patient
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to assess the impact of objective sleep duration on blood glucose control in type 1 diabetes adult patients.
This study will also evaluate the impact of objective sleep duration on blood pressure over a 24-hour period and the impact of objective sleep duration on quality of life.
Last, it will investigate the influence of objective physical activity duration on blood glucose control, blood pressure and quality of life.
Read the detailed description
The objective of this study is to assess the impact of objective sleep duration on blood glucose control in type 1 diabetes adult patients.
This study will also evaluate the impact of objective sleep duration on blood pressure over a 24-hour period and the impact of objective sleep duration on quality of life.
Last, it will investigate the influence of objective physical activity duration on blood glucose control, blood pressure and quality of life.
This study will enrol ambulatory patients only. On day 0, patients receive an actimeter and an ambulatory blood pressure monitoring device. The actimeter measures activity and sleep duration. The patient keeps the actimeter for 3 consecutive days and the blood pressure monitoring device for 24 hours. A blood sample is also collected.
Patients will be divided into 2 groups, based on objective sleep duration: 'short-sleepers' and 'long-sleepers'. The threshold will be the median of the total population. HbA1c will be compared between the 2 groups with a Student test or a Mann-Whitney test, depending on the normality of distribution.
A model of multiple linear regression will be created. HbA1c will be entered as dependant variable and objective sleep duration as independent variable
Patients will be divided into 2 groups, based on objective activity duration: 'low-activity' and 'high-activity'. The threshold will be the median of the total population. HbA1c, blood pressure, quality of life, biological results and general characteristics will be compared between the 2 groups with a Student test or a Mann-Whitney test, depending on the normality of distribution. Qualitative variables will be studied with a chi-square test.
- Conditions
- Type 1 Diabetes
- Being tested
- Actimeter + blood pressure monitoring
- Keywords
- Type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actimeter + blood pressure monitoringDevice
Also called Actiwatch-16, Mini-Mitter Inc, Bend,Oregon, SPACELABS 90207
Patients will receive an actimeter that they will wear for 3 days and an ambulatory blood pressure monitoring device that they will keep for 24 hours.
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c in %
Measured: Day 0 or Day 3
Secondary outcomes (3)
Objective sleep duration in minutes
Measured: Day 0 to Day 3
Blood pressure in cm Hg
Measured: Day 0, 24 hours
Quality of life assessed through questionnaire
Measured: Day 0 to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: intermediary analysis was performed and significant results were found for the main objective
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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Yves Benhamou, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017965
- Sponsor's protocol ID
- 0917
- Other IDs
- 2009-A00816-51
- Acronym
- DIAPASOM2
- Status last verified
- Oct 2012
- First submitted
- 20 Nov 2009
- Last updated
- 5 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Borel AL, Pepin JL, Nasse L, Baguet JP, Netter S, Benhamou PY. Short sleep duration measured by wrist actimetry is associated with deteriorated glycemic control in type 1 diabetes. Diabetes Care. 2013 Oct;36(10):2902-8. doi: 10.2337/dc12-2038. Epub 2013 May 28.
PubMed 23715755
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Objective Sleep Duration on Blood Glucose Control in Type 1 Diabetes Adult Patients
- ClinicalTrials.gov ID
- NCT01017965
- Acronym / sponsor ID
- DIAPASOM2 / 0917
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: intermediary analysis was performed and significant results were found for the main objective
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 23 Nov 2009 (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.
The objective of this study is to assess the impact of objective sleep duration on blood glucose control in type 1 diabetes adult patients.
This study will also evaluate the impact of objective sleep duration on blood pressure over a 24-hour period and the impact of objective sleep duration on quality of life.
Last, it will investigate the influence of objective physical activity duration on blood glucose control, blood pressure and quality of life.
Detailed description
The objective of this study is to assess the impact of objective sleep duration on blood glucose control in type 1 diabetes adult patients.
This study will also evaluate the impact of objective sleep duration on blood pressure over a 24-hour period and the impact of objective sleep duration on quality of life.
Last, it will investigate the influence of objective physical activity duration on blood glucose control, blood pressure and quality of life.
This study will enrol ambulatory patients only. On day 0, patients receive an actimeter and an ambulatory blood pressure monitoring device. The actimeter measures activity and sleep duration. The patient keeps the actimeter for 3 consecutive days and the blood pressure monitoring device for 24 hours. A blood sample is also collected.
Patients will be divided into 2 groups, based on objective sleep duration: 'short-sleepers' and 'long-sleepers'. The threshold will be the median of the total population. HbA1c will be compared between the 2 groups with a Student test or a Mann-Whitney test, depending on the normality of distribution.
A model of multiple linear regression will be created. HbA1c will be entered as dependant variable and objective sleep duration as independent variable
Patients will be divided into 2 groups, based on objective activity duration: 'low-activity' and 'high-activity'. The threshold will be the median of the total population. HbA1c, blood pressure, quality of life, biological results and general characteristics will be compared between the 2 groups with a Student test or a Mann-Whitney test, depending on the normality of distribution. Qualitative variables will be studied with a chi-square test.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll type 1 diabetes patients who come for a consultation in Grenoble University Hospital.
Key inclusion criteria (4 listed)
- Patient affiliated to Social Security
- Written consent to participate to the study
- Ambulatory medical follow-up
- Patient with type 1 diabetes, defined by the criteria of the American Diabetes Association in 1997, stable (no ketoacidosis episode or hypoglycaemia with loss of consciousness requiring the intervention of a third person, during the previous month)
Key exclusion criteria (8 listed)
- Underage patient, major patient under guardianship or protected by the Law
- Pregnant, parturient or breastfeeding woman
- Person with no freedom (prisoner), person hospitalized without consent and not protected by the Law
- Non-stabilized diabetes with at least one ketoacidosis episode or hypoglycaemia with loss of consciousness requiring the intervention of a third person, during the previous month.
- Bedridden person or person with mobility impairment.
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 |
|---|---|---|
| Actimeter + blood pressure monitoringAlso: Actiwatch-16, Mini-Mitter Inc, Bend,Oregon, SPACELABS 90207Patients will receive an actimeter that they will wear for 3 days and an ambulatory blood pressure monitoring device that they will keep for 24 hours. | Device | – |
Primary outcome
HbA1c in %
Time frame: Day 0 or Day 3
3 secondary outcomes
Objective sleep duration in minutes
Time frame: Day 0 to Day 3
Blood pressure in cm Hg
Time frame: Day 0, 24 hours
Quality of life assessed through questionnaire
Time frame: Day 0 to Day 3
Results and safety
The study was stopped early (reason given: intermediary analysis was performed and significant results were found for the main objective). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
- Derived from this study: PubMed 23715755Borel AL, Pepin JL, Nasse L, Baguet JP, Netter S, Benhamou PY. Short sleep duration measured by wrist actimetry is associated with deteriorated glycemic control in type 1 diabetes. Diabetes Care. 2013 Oct;36(10):2902-8. doi: 10.2337/dc12-2038. Epub 2013 May 28.
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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.
Pierre-Yves Benhamou, 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 4 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 5 Oct 2012. 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 was stopped early (reason given: intermediary analysis was performed and significant results were found for the main objective). Results are not available in the source record.
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 in % (time frame: Day 0 or Day 3). 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 NCT01017965, 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 5 Oct 2012.