Type 1 DiabetesDiabeloopWP3NCT01640223
Creation of a Patient Database for Silicon Patient Simulation, Glucose Sensor Variability and Pharmacokinetic Study of Debiotech Jewelpump
A study testing Dexcom7 in people with Type 1 Diabetes, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 7 sites in France.
Trial summary
The aim this study is the acquisition and management of a data base for the development of the glycaemic regulation algorithms. This database will integrate the measures of blood glucose and the glycaemia level of the Dexcom sensor on a regular time, the injections of insulin delivered by Debiotech JewelPUMP and the… 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?
- Dexcom7
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 7 sitesFrance
- Study dates
- Mar 2012to Oct 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
- Patients with diabetes type 1 Treaty by external insulin pump
- Duration of diabetes than 2 years or c indosable peptide
- Practicing insulin functional (IF) or food plan sets
- Patient having a HbA1c < 10%
- Patient age over 18 years
- Patient having signed the form of collection of free consent and informed
- 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 (in particular kidney or heart failure)
- Psychiatric pathologies incompatible with the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU Jean Minjoz
Besançon, 25030
CHU de Caen
Caen, 14000
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106
University Hospital Grenoble
Grenoble, 38043
Chu Montpellier
Montpellier, Montpellier, 34295
CHU de Nancy
Nancy, 54500
CHU Toulouse
Toulouse, Toulouse, 31403
About this study
Official title: SEMI-CLOSED LOOP "FOR THE CONTROL OF BLOOD GLUCOSE IN DIABETIC SUBJECTS DIABELOOP First CLINICAL PROJECT: Under Project 3 (UP3), CREATING A DATABASE
The aim this study is the acquisition and management of a data base for the development of the glycaemic regulation algorithms. This database will integrate the measures of blood glucose and the glycaemia level of the Dexcom sensor on a regular time, the injections of insulin delivered by Debiotech JewelPUMP and the level of insulin in the blood. This database will also contain the bolus of insulin injected at meals and the content of meals, the reduction insulin level during physical activity and the quantification of this physical activity. A study will also be conducted to compare the pharmacokinetics of a bolus of insulin identical with the JewelPUMP either the usual pump of the patient.
- Conditions
- Type 1 Diabetes
- Being tested
- Dexcom7
- 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.
Dexcom7Device
patients will wear 2 Dexcom sensors 3 days before hospitalization.
Dexcom7Device
patients will wear 2 Dexcom sensor one day before hospitalization
| Study group | Role | What they receive |
|---|---|---|
| D-3 sensor | Experimental | patients will be equiped with 2 Dexcom sensors 3 days before hospitalization Receives: Device: Dexcom7 |
| D-1 sensor | Experimental | patients will be equiped with 2 Dexcom sensors one day before hospitalization Receives: Device: Dexcom7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of data collected
The aim of the study is data collection of patient blood glucose and insulin in patients treated with continuous subcutaneous infusion insulin pump with a patchpump (JewelPUMPTM Debiotech) and equipped with two glucose sensors for the development of the control algorithm glucose.
Blood sample are done every hour (achievement of glucose and insulin assays) ans every 15 minutes during 2 hours after meals.
Measured: Blood glucose and insuline will be collected during the hospital stay of patient (in average 25 hours)
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 startMar 2012
- Primary completionOct 2012
- Study completionOct 2012
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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, Study chair, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteBruno GUERCI, MD PHD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640223
- Sponsor's protocol ID
- 2011-A00726-35
- Acronym
- DiabeloopWP3
- Status last verified
- Oct 2014
- First submitted
- 5 Jul 2012
- 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
- SEMI-CLOSED LOOP "FOR THE CONTROL OF BLOOD GLUCOSE IN DIABETIC SUBJECTS DIABELOOP First CLINICAL PROJECT: Under Project 3 (UP3), CREATING A DATABASE
- ClinicalTrials.gov ID
- NCT01640223
- Acronym / sponsor ID
- DiabeloopWP3 / 2011-A00726-35
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 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 aim this study is the acquisition and management of a data base for the development of the glycaemic regulation algorithms. This database will integrate the measures of blood glucose and the glycaemia level of the Dexcom sensor on a regular time, the injections of insulin delivered by Debiotech JewelPUMP and the level of insulin in the blood. This database will also contain the bolus of insulin injected at meals and the content of meals, the reduction insulin level during physical activity and the quantification of this physical activity. A study will also be conducted to compare the pharmacokinetics of a bolus of insulin identical with the JewelPUMP either the usual pump of the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-3 sensor | Experimental | Device: Dexcom7patients will be equiped with 2 Dexcom sensors 3 days before hospitalization |
| D-1 sensor | Experimental | Device: Dexcom7patients will be equiped with 2 Dexcom sensors one day before hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with diabetes type 1 Treaty by external insulin pump
- Duration of diabetes than 2 years or c indosable peptide
- Practicing insulin functional (IF) or food plan sets
- Patient having a HbA1c < 10%
- Patient age over 18 years
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 (in particular kidney or heart failure)
- Psychiatric pathologies incompatible 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 |
|---|---|---|
| Dexcom7patients will wear 2 Dexcom sensors 3 days before hospitalization. | Device | D-3 sensor |
| Dexcom7patients will wear 2 Dexcom sensor one day before hospitalization | Device | D-1 sensor |
Primary outcome
Percentage of data collected
Time frame: Blood glucose and insuline will be collected during the hospital stay of patient (in average 25 hours)
The aim of the study is data collection of patient blood glucose and insulin in patients treated with continuous subcutaneous infusion insulin pump with a patchpump (JewelPUMPTM Debiotech) and equipped with two glucose sensors for the development of the control algorithm glucose. Blood sample are done every hour (achievement of glucose and insulin assays) ans every 15 minutes during 2 hours after meals.
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.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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 study chair
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Bruno GUERCI, MD PHD principal investigator
Central Hospital, Nancy, France
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom7 in people with Type 1 Diabetes, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 7 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 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 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 7 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?
Percentage of data collected (time frame: Blood glucose and insuline will be collected during the hospital stay of patient (in average 25 hours)). 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.