Type 1 DiabetesPhase 3NCT02097316
Feasibility Study of the JewelPump Version 3
A Phase 3 study testing JewelPump and usual insulin pump 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
The study will be conducted, in cross-over with a time interval of at least 2 days between 2 treatment periods. Patients will be randomized into 2 groups According to the order of the randomization, patients will bear the JewelPump for 5 days, followed by a period of 5 days of treatment with their usual pumps. 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?
- JewelPump and usual insulin pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesFrance
- Study dates
- Jun 2014to Sep 2014
- Phase
- Phase 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
- Patients type 1 diabetics treated by external insulin pump;
- Patients with HbA1c < 8.5%
- Patients who signed consent
Who cannot join
- Patients type 2 diabetics
- Patients who have all serious diseases that could interfere with the study
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier Sud Francilien
Évry, 91000
CHU Marseille-Hôpital Nord
Marseille, 13000
CHU Strasbourg
Strasbourg, 67091
About this study
The study will be conducted, in cross-over with a time interval of at least 2 days between 2 treatment periods. Patients will be randomized into 2 groups According to the order of the randomization, patients will bear the JewelPump for 5 days, followed by a period of 5 days of treatment with their usual pumps.
Read the detailed description
The JewelPump (Debiotech) will be compared to the conventional pumps. Patients will treated with the JewelPump during 5 days, and with their usual pump during 5 other days.
The study will be conduct with 15 patients at the following investigation centers : Corbeil Hospital, CHU of Strasbourg, and CHRU of Marseille.
- Conditions
- Type 1 Diabetes
- Being tested
- JewelPump, usual insulin pump
- Keywords
- Glycemic control, JewelPump accuracy
- 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.
JewelPumpDevice
usual insulin pumpDevice
| Study group | Role | What they receive |
|---|---|---|
| JewelPump | Experimental | JewelPump for the first treatment period followed by the usual pump for the second treatment period Receives: Device: JewelPump; Device: usual insulin pump |
| Usual insulin pump | Active comparator | Patients in the arm 2, will have the usual insulin pump for the first treatment period, followed with the second period which they will have the JewelPump. Receives: Device: JewelPump; Device: usual insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in glycemic area 70-180 mg / dl, measured continuously for 5 days with a continuous glucose monitoring (CGM) DEXCOM G4
Evaluate the non-inferiority of JewelPump compared to the usual pump patient, on glycemic control.
Measured: up to 5 days of each treatment period
Secondary outcomes (1)
Time spent in the strict glycemic area 80-140 mg / dl
Evaluate the superiority of JewelPump versus usual pump;
Measured: up to 5 days of 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 posted27 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionSep 2014
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 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 Hospitalier Sud FrancilienNathalie JEANDIDIER, Pr., Principal investigator, University Hospital, Strasbourg, FranceDenis RACCAH, Pr., Principal investigator, Centre Hospitalier Universitaire de MarseilleGuillaume CHARPENTIER, MD, Study chair, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097316
- Sponsor's protocol ID
- 2013-A00792-43
- Status last verified
- Oct 2014
- First submitted
- 26 Sep 2013
- Last updated
- 27 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the JewelPump Version 3
- ClinicalTrials.gov ID
- NCT02097316
- Acronym / sponsor ID
- 2013-A00792-43
- Conditions
- Type 1 Diabetes
- Keywords
- Glycemic control, JewelPump accuracy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Mar 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.
The study will be conducted, in cross-over with a time interval of at least 2 days between 2 treatment periods. Patients will be randomized into 2 groups According to the order of the randomization, patients will bear the JewelPump for 5 days, followed by a period of 5 days of treatment with their usual pumps.
Detailed description
The JewelPump (Debiotech) will be compared to the conventional pumps. Patients will treated with the JewelPump during 5 days, and with their usual pump during 5 other days.
The study will be conduct with 15 patients at the following investigation centers : Corbeil Hospital, CHU of Strasbourg, and CHRU of Marseille.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JewelPump | Experimental | Device: JewelPump, Device: usual insulin pumpJewelPump for the first treatment period followed by the usual pump for the second treatment period |
| Usual insulin pump | Active comparator | Device: JewelPump, Device: usual insulin pumpPatients in the arm 2, will have the usual insulin pump for the first treatment period, followed with the second period which they will have the JewelPump. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients type 1 diabetics treated by external insulin pump;
- Patients with HbA1c < 8.5%
- Patients who signed consent
Key exclusion criteria (2 listed)
- Patients type 2 diabetics
- Patients who have all serious diseases that could interfere with the study
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 |
|---|---|---|
| JewelPump | Device | JewelPump, Usual insulin pump |
| usual insulin pump | Device | JewelPump, Usual insulin pump |
Primary outcome
Time spent in glycemic area 70-180 mg / dl, measured continuously for 5 days with a continuous glucose monitoring (CGM) DEXCOM G4
Time frame: up to 5 days of each treatment period
Evaluate the non-inferiority of JewelPump compared to the usual pump patient, on glycemic control.
1 secondary outcome
Time spent in the strict glycemic area 80-140 mg / dl
Time frame: up to 5 days of 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 27 Oct 2014.
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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 Hospitalier Sud Francilien
Nathalie JEANDIDIER, Pr. principal investigator
University Hospital, Strasbourg, France
Denis RACCAH, Pr. principal investigator
Centre Hospitalier Universitaire de Marseille
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JewelPump and usual insulin pump 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 3 inclusion and 2 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 27 Oct 2014. 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 phase mean?
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 glycemic area 70-180 mg / dl, measured continuously for 5 days with a continuous glucose monitoring (CGM) DEXCOM G4 (time frame: up to 5 days of 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 27 Oct 2014.