Type1diabetesDIABELOOPNCT01640210
Technical Evaluation Of JewelPUMP In Type 1 Diabetic Patients Treated With Extern Insulin Pump
A study testing JewelPUMP (insulin patch pump) in people with Type1diabetes, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 2 sites in France.
Trial summary
The main objective of the study is to verify the reliability of the solutes volumes issued by the Debiotech JewelPUMPTM controlled by its remote. Three clinical sites are participating in this study: CHSF, Service of Endocrinology and Diabetology, CORBEIL-ESSONNES (91): Dr. Guillaume CHARPENTIER, Dr. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type1diabetes
- What is being tested?
- JewelPUMP (insulin patch pump)
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2011to Mar 2012
- 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
- Type 1 Diabetic patient treated by external insulin pump for at least 6 months
- Patient with a HbA1c < 9%
- Patient age over 18 years of age
- Patient having signed the consent and informed form
- Patient affiliated with the social security
Who cannot join
- Patients with diabetes type 2
- Patient pregnant or likely to be
- All serious pathologies that can interfere with the study
- Incompatible psychiatric pathologies with the study
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Jean Minjoz
Besançon, 25030
University Hospital Grenoble
Grenoble, 38043
About this study
Official title: TECHNICAL EVALUATION OF JEWELPUMP IN TYPE 1 DIABETIC PATIENTS TREATED WITH EXTERN INSULIN PUMP
The main objective of the study is to verify the reliability of the solutes volumes issued by the Debiotech JewelPUMPTM controlled by its remote.
Three clinical sites are participating in this study:
Read more
- CHSF, Service of Endocrinology and Diabetology, CORBEIL-ESSONNES (91): Dr. Guillaume CHARPENTIER, Dr. Sylvia FRANC
- Grenoble University Hospital, Department of Endocrinology, Diabetes Diseases, Nutrition, GRENOBLE (38): Pr Pierre-Yves BENHAMOU
- CHU Jean Minjoz, Department of Endocrinology and Diabetology, BESANCON (25): Professor Alfred PENFORNIS, Dr. Annie CLERGEOT
The study will be conducted in 20 patients with type 1 diabetes treated by external insulin pump. Patients will be informed of the study during a screening visit. After signing the informed consent, they will return to the center where they will wear a JewelPUMPTM containing saline water, they will use their pumps in parallel. The investigator or nurse education will form the operation of the JewelPUMPTM and they will be instructed to replicate the same settings between their usual and JewelPUMPTM pump. The patient will be asked to complete visual analog scales of satisfaction with their usual treatment and the various elements of the devices (usual pump, and JewelPUMPTM) have been weighed using a precision balance to have a form of a base for comparison.
Patients will leave home for a period of about three days, but they will have to come back every days to the center. They will be asked to collect all events arising (programming problems to deliver a bolus, hardware failure ...) in a booklet.
At the end of study visit, patients will return to the center where the volumes will be assessed by the perfused weighed the various components and devices where they will complete the visual analog scales of satisfaction at endpoint.
- Conditions
- Type1diabetes
- Being tested
- JewelPUMP (insulin patch pump)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JewelPUMP (insulin patch pump)Device
The study will be proposed during the visit of selection.
Visit of inclusion:
This visit will take place after having received the consent of the patient. Women will be asked to achieve a pregnancy test. Patients will wear a JewelPUMP containing saline solution in parallel with their usual insulin pump. They will be trained to use JewelPUMP.
Patients treated with insulin pump will be instructed to reproduce the same "programming" between their usual pump and the JewelPUMP, they will use in parallel.
Volume infused will be evaluated during a period of basal and bolus with a precision scale.
Patient monitoring: Patient have to come back to the centre every 24 hours for 3 days. Study visit:
Patients will be asked to fill out a questionnaire of satisfaction to the JewelPUMPTM and Visual scales.
Volume infused will be evaluated with a precision scale, by comparison of weight of JewelPUMP and patients' usual pump
What is being measured
The primary outcome is the main question the study is designed to answer.
weight of the insulin pump (JewelPUMP and usual pump)
accuracy of volume delivered by the JewelPUMP by comparison of the difference of weight between usual pump and JewelPUMP at Day 1, Day 2 and day 3.
Measured: 3 Days
Secondary outcomes (3)
satisfaction of patients
the satisfaction of the JewelPUMP for the patients is evaluated with visual analogic scales.
patients indicate the their satisfaction of the JewelPUMP on a scale of 10 centimeter. on the left = no satisfaction and on the right = 100% satisfaction.
Measured: 3 days
handling
the workability of the JewelPUMP for the patients is evaluated with visual analogic scales.
patients indicate the workability of the JewelPUMP on a scale of 10 centimeter. on the left = no workability and on the right = 100% workability.
Measured: 3 days
acceptability
the acceptability of the JewelPUMP for the patients is evaluated with visual analogic scales.
patients indicate the acceptability of the JewelPUMP on a scale of 10 centimeter. on the left = no acceptability and on the right = 100% acceptability.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startNov 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 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
- Guillaume Charpentier, MD, Principal investigator, CHSF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640210
- Sponsor's protocol ID
- 2011-A00666-35
- Acronym
- DIABELOOP
- Status last verified
- Dec 2011
- First submitted
- 25 Jun 2012
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TECHNICAL EVALUATION OF JEWELPUMP IN TYPE 1 DIABETIC PATIENTS TREATED WITH EXTERN INSULIN PUMP
- ClinicalTrials.gov ID
- NCT01640210
- Acronym / sponsor ID
- DIABELOOP / 2011-A00666-35
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 13 Jul 2012 (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 main objective of the study is to verify the reliability of the solutes volumes issued by the Debiotech JewelPUMPTM controlled by its remote.
Three clinical sites are participating in this study:
- CHSF, Service of Endocrinology and Diabetology, CORBEIL-ESSONNES (91): Dr. Guillaume CHARPENTIER, Dr. Sylvia FRANC
- Grenoble University Hospital, Department of Endocrinology, Diabetes Diseases, Nutrition, GRENOBLE (38): Pr Pierre-Yves BENHAMOU
- CHU Jean Minjoz, Department of Endocrinology and Diabetology, BESANCON (25): Professor Alfred PENFORNIS, Dr. Annie CLERGEOT
The study will be conducted in 20 patients with type 1 diabetes treated by external insulin pump. Patients will be informed of the study during a screening visit. After signing the informed consent, they will return to the center where they will wear a JewelPUMPTM containing saline water, they will use their pumps in parallel. The investigator or nurse education will form the operation of the JewelPUMPTM and they will be instructed to replicate the same settings between their usual and JewelPUMPTM pump. The patient will be asked to complete visual analog scales of satisfaction with their usual treatment and the various elements of the devices (usual pump, and JewelPUMPTM) have been weighed using a precision balance to have a form of a base for comparison.
Patients will leave home for a period of about three days, but they will have to come back every days to the center. They will be asked to collect all events arising (programming problems to deliver a bolus, hardware failure ...) in a booklet.
At the end of study visit, patients will return to the center where the volumes will be assessed by the perfused weighed the various components and devices where they will complete the visual analog scales of satisfaction at endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 1 Diabetic patient treated by external insulin pump for at least 6 months
- Patient with a HbA1c < 9%
- Patient age over 18 years of age
- Patient having signed the consent and informed form
- Patient affiliated with the social security
Key exclusion criteria (4 listed)
- Patients with diabetes type 2
- Patient pregnant or likely to be
- All serious pathologies that can interfere with the study
- Incompatible psychiatric pathologies 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 (insulin patch pump)The study will be proposed during the visit of selection. Visit of inclusion: This visit will take place after having received the consent of the patient. Women will be asked to achieve a pregnancy test. Patients will wear a JewelPUMP containing saline solution in parallel with their usual insulin pump. They will be trained to use JewelPUMP. Patients treated with insulin pump will be instructed to reproduce the same "programming" between their usual pump and the JewelPUMP, they will use in parallel. Volume infused will be evaluated during a period of basal and bolus with a precision scale. Patient monitoring: Patient have to come back to the centre every 24 hours for 3 days. Study visit: Patients will be asked to fill out a questionnaire of satisfaction to the JewelPUMPTM and Visual scales. Volume infused will be evaluated with a precision scale, by comparison of weight of JewelPUMP and patients' usual pump | Device | – |
Primary outcome
weight of the insulin pump (JewelPUMP and usual pump)
Time frame: 3 Days
accuracy of volume delivered by the JewelPUMP by comparison of the difference of weight between usual pump and JewelPUMP at Day 1, Day 2 and day 3.
3 secondary outcomes
satisfaction of patients
Time frame: 3 days
handling
Time frame: 3 days
acceptability
Time frame: 3 days
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 13 Jul 2012.
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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.
Guillaume Charpentier, MD principal investigator
CHSF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JewelPUMP (insulin patch pump) in people with Type1diabetes, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 2 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 5 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 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
weight of the insulin pump (JewelPUMP and usual pump) (time frame: 3 Days). 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 13 Jul 2012.