Type 1 DiabetesPhase 2/3WP6-1NCT02101229
Validation of the Artificial Pancreas Diabeloop Algorithm in the Hospital
A Phase 2/3 study testing Insulin, Asp(B28)- in people with Type 1 Diabetes, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 3 sites in France.
Trial summary
To assess whether the DIABELOOP algorithm provides better glycemic control than the usual algorithm of T1D patients on pump therapy: at meals, with CHO roughly assessed by the patient. during and after physical activity sessions qualified as moderate by the patient. 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?
- Insulin, Asp(B28)-
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesFrance
- Study dates
- May 2014to Feb 2015
- Phase
- Phase 2/3
- 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
- Patient type 1 diabetic for at least one year
- Patient treated by external insulin pump for at least 6 months
- Patients with HbA1c <9%
- Patient affiliated with Social Security.
- Patient able to perform two tests of physical activity of 30 minutes (one event in each treatment period);
- aged at least 18 years Patient;
- Patient who signed consent
Who cannot join
- All serious disease that could interfere with the study
- BMI > 30 kg/m2
- insulin requirement > 2 U/kg/day
- Patient benefiting from a measure of legal protection;
- Pregnant or likely to be women.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier du Sud Francillien
Évry, 91058
University Hospital of Grenoble
Grenoble, 38043
University Hospital of Montpellier
Montpellier, 34295
About this study
Official title: Diabeloop WP6-1 : Validation of the Artificial Pancreas Diabeloop Algorithm in the Hospital
To assess whether the DIABELOOP algorithm provides better glycemic control than the usual algorithm of T1D patients on pump therapy:
- at meals, with CHO roughly assessed by the patient.
- during and after physical activity sessions qualified as moderate by the patient.
Primary endpoint : time within the glycemic reference range. The study will be conduct with 15 patients at the following investigation centers : Corbeil Hospital, CHU of Grenoble, and CHU of Montpellier.
Read the detailed description
The 15 patients will have 2 visits during 24 hours (day and night), once with their usual algorithm and once with the Diabeloop system.
- Conditions
- Type 1 Diabetes
- Being tested
- Insulin, Asp(B28)-
- Keywords
- Glycemic control algorithm, closed loop, artificial pancreas
- 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.
Insulin, Asp(B28)-Drug
Also called NovoRapid insulin
the insulin dose is calculated by the "Diabeloop" algorithm and then administered to the patient
| Study group | Role | What they receive |
|---|---|---|
| unsual treatment | No intervention | The patient will have his usual treatment in this arm |
| The Diabeloop algorithm | Experimental | In this arm, the insulin Asp(B28) dose is calculated by the algorithm based on the usual treatment of the patient, the ratio I / C, the intensity of physical activity and blood glucose sensor. Receives: Drug: Insulin, Asp(B28)- |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in blood glucose range [70-180 mg/dl]
comparing the time spent in [70-180 mg/dl] with usual algorithm vs Diabeloop algorithm.
Measured: up to 24 hours after each treatment period
Secondary outcomes (2)
Time spent Blood Glucose range [80-140 mg/dl]
Comparing the time spent in range [80-140 mg/dl] with usual algorithm vs Diabeloop algorithm
Measured: 24 hours after each treatment period
time spent below 70 mg/dl and above 180 mg/dl
Measured: up to 24 hours after each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2015
- Study completionFeb 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.
- 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 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvia FRANC, MD, Principal investigator, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteAhmed DAOUDI, MD, Principal investigator, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabètePierre-Yves BENHAMOU, Pr, Principal investigator, CHU of GrenobleSandrine LABLANCHE, MD, Principal investigator, CHU of GrenobleEric RENARD, Pr, Principal investigator, CHU of MontpellierAnne FARRET, MD, Principal investigator, CHU of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101229
- Sponsor's protocol ID
- 2013-A01657-38
- Acronym
- WP6-1
- Status last verified
- Jul 2015
- First submitted
- 21 Mar 2014
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabeloop WP6-1 : Validation of the Artificial Pancreas Diabeloop Algorithm in the Hospital
- ClinicalTrials.gov ID
- NCT02101229
- Acronym / sponsor ID
- WP6-1 / 2013-A01657-38
- Conditions
- Type 1 Diabetes
- Keywords
- Glycemic control algorithm, closed loop, artificial pancreas
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 2 Apr 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.
To assess whether the DIABELOOP algorithm provides better glycemic control than the usual algorithm of T1D patients on pump therapy:
- at meals, with CHO roughly assessed by the patient.
- during and after physical activity sessions qualified as moderate by the patient.
Primary endpoint : time within the glycemic reference range. The study will be conduct with 15 patients at the following investigation centers : Corbeil Hospital, CHU of Grenoble, and CHU of Montpellier.
Detailed description
The 15 patients will have 2 visits during 24 hours (day and night), once with their usual algorithm and once with the Diabeloop system.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unsual treatment | No intervention | –The patient will have his usual treatment in this arm |
| The Diabeloop algorithm | Experimental | Drug: Insulin, Asp(B28)-In this arm, the insulin Asp(B28) dose is calculated by the algorithm based on the usual treatment of the patient, the ratio I / C, the intensity of physical activity and blood glucose sensor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient type 1 diabetic for at least one year
- Patient treated by external insulin pump for at least 6 months
- Patients with HbA1c <9%
- Patient affiliated with Social Security.
- Patient able to perform two tests of physical activity of 30 minutes (one event in each treatment period);
Key exclusion criteria (5 listed)
- All serious disease that could interfere with the study
- BMI > 30 kg/m2
- insulin requirement > 2 U/kg/day
- Patient benefiting from a measure of legal protection;
- Pregnant or likely to be women.
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 |
|---|---|---|
| Insulin, Asp(B28)-Also: NovoRapid insulinthe insulin dose is calculated by the "Diabeloop" algorithm and then administered to the patient | Drug | The Diabeloop algorithm |
Primary outcome
Time spent in blood glucose range [70-180 mg/dl]
Time frame: up to 24 hours after each treatment period
comparing the time spent in [70-180 mg/dl] with usual algorithm vs Diabeloop algorithm.
2 secondary outcomes
Time spent Blood Glucose range [80-140 mg/dl]
Time frame: 24 hours after each treatment period
time spent below 70 mg/dl and above 180 mg/dl
Time frame: up to 24 hours after each treatment period
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 30 Jul 2015.
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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.
Sylvia FRANC, MD principal investigator
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Ahmed DAOUDI, MD principal investigator
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Pierre-Yves BENHAMOU, Pr principal investigator
CHU of Grenoble
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Insulin, Asp(B28)- in people with Type 1 Diabetes, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 3 sites 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 7 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 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time spent in blood glucose range [70-180 mg/dl] (time frame: up to 24 hours after each treatment period). 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 30 Jul 2015.