Type 1 DiabetesPhase 3DiabeloopWP6-0NCT01754181

Initial Testing of the Diabeloop Algorithm in T1D Patients on Pump Therapy Over the Prandial Period and Physical Activity.

A Phase 3 study testing Insulin 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The main objective is to assess if the Diabeloop algorithm provides better glycemic control than a "manual" usual algorithm of patients with type 1 diabetes treated by insulin pump during meals, and during activity qualified "moderate" to "severe" by the patients. The study will be conducted in 18 patients. 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
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 3 sitesFrance
Study dates: Mar 2013to Jul 2013
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 with type 1 diabetes treated by external insulin pump;
Patients with HbA1c <8.5%.
Patients aged 18 years or less;
Patient who signed consent;
Patient affiliated with Social Security.
For Grenoble and Toulouse Centers (Prandial algorithm test : MEAL):

Show all 9Show fewer

Patient is practicing functional insulin therapy is a fixed meal plan.
For CHSF center (test of algorithm during activity):
Patient able to perform moderate or intense activity during 30 minutes.

Who cannot join

Patients with type 2 diabetes
All serious diseases that could interfere with the study
Insulin resistance and obesity (BMI> 30 kg/m2 and / or insulin requirements> 2 U / kg / day)

Trial locations and contacts

3 sites in 1 country.

France3 sites

Centre Hospitalier Sud Francilien
Évry, 91058
University Hospital of Grenoble
Grenoble, 38043
University Hospital of Toulouse
Toulouse, 31403

Other trials in France

About this study

Official title: Development of the Glycemic Control Algorithm, in Prandial and Physical Effort Situations.

The study will be conducted in 18 patients. The investigation centers are: CHSF (for Diabeloop algorithm test during activity), CHU of Grenoble and CHU of Toulouse (for Diabeloop algorithm test during meals.

Read the detailed description

Grenoble and Toulouse will test the prandial algorithm with several carbohydrate intake and a primer of 50% or 75% of the total bolus. Groups of patients are described as follows:
Group I: patients have a meal with the usual carbohydrate intake. The meal bolus is made according to the current treatment.
Group II: patients have a meal with a "low" carbohydrate intake (50% reduction of carbohydrate).
Group III: patients have a meal with a "strong" carbohydrate intake (increase 50% of carbohydrate).
Group IV: patients of group IV have each meal with carbohydrate intake but their usual bolus will be omitted.
Inclusion visit V1: The study will be proposed at the patients who meet the inclusion criteria. After signing the consent, the investigator shall designate one group for each patient.
Visit V2 (24 hours before the visit V3): Installation, calibration and education of two glucose sensors dexcom G4 ™ will be performed by a nurse. The patient will keep two sensors until the end of the study (end of V4).
Visit V3 (algorithm test): Patient will be fitted with its insulin pump and the two sensors dexcom G4 ™. These will be coupled by the engineer LETI to the computer on which is installed the control algorithm to be tested. Lunch will be taken at 1 pm. The algorithm will provide proposals insulin every 15 minutes until 6 pm.
Visit V4 (patient control): Patient will be fitted with two sensors dexcom G4 ™ and its insulin pump programmed according to the usual algorithm. The meal will be taken at 1h PM. Patient can leave the site at 6 pm after removal of sensors.
CHSF (Centre Hospitalier Sud Francilien) will test the algorithm glycemic control during physical activity of moderate (50% VO2max) or high intensity (75% VO2max) for 30 minutes on a bicycle ergometer. In different situations, three patient groups will be created:
Group A: Patients practice an "average" physical activity(50% VO2max) with usual temporary basal reduction (usually 50% of reduction during the test and 2h next).
Group B: Patients practice an "intense" physical activity (75% VO2max) with usual temporary basal reduction (usually 80% of reduction during the test and 2h after).
Group C: patients practice an "average" physical activity (50% VO2max) but without concomitant reduction of temporary basal.
Inclusion visit V1 : The study will be proposed at the patients who meet the inclusion criteria. After signing the consent, the investigator shall designate one group for each patient.
Visit V2 : Patient will be equipped with two sensors dexcom G4 ™ and a heart rate monitor. Calibrated meal is expected at 11h 30 pm. The patient will be administered his insulin dose according to his usual algorithm. The physical test will begin three hours after the meal. It will be carried on bicycle ergometer for 30 minutes at an medium or high intensity. (Average = 50% VO2max, or high level = 75% VO2max).
Visit V3: The same test is repeated for each patient during this visit. Its insulin pump will be controlled by the doses proposal of the algorithm after manual validation by the investigator. These will continue until the next morning, and the patient will spend overnight in the hospital.

Conditions: Type 1 Diabetes
Being tested: Insulin
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.

InsulinDrug
the intervention is applied only at the dose of insulin

Study groups in NCT01754181
Study group	Role	What they receive
Proposed treatment by Diabeloop algorithm	Experimental	the insulin 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
usual treatment	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Time spent in glucose reference intervals
Measured: After the end of the tests

Secondary outcomes (1)

Measuring glucose sensor 2h, 3h and 4h post-prandial and AUC, in every situation tested to evaluate the efficacy and safety (time spent in hypoglycemia)
To evaluate the efficacy and safety of prandial algorithm, informed carbohydrate intake by the patient either quantitatively or semi-quantitative, or not informed way.
Measured: After the end of the tests

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Jul 2013

First posted21 Dec 2012 (estimated)
Study startMar 2013
Primary completionJun 2013
Study completionJul 2013

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: Health services research
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01754181
Sponsor's protocol ID: 2012-A01489-34
Acronym: DiabeloopWP6-0
Status last verified: Oct 2014
First submitted: 18 Dec 2012
Last updated: 27 Oct 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Cholesterol Lowering and Residual Risk in Diabetes, Type 1
Type 1 Diabetes
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
RecruitingPhase 4
INfluenza VaccInation To Mitigate typE 1 Diabetes
Diabetes Mellitus, Type 1

All Type 1 Diabetes trials

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: Development of the Glycemic Control Algorithm, in Prandial and Physical Effort Situations.
ClinicalTrials.gov ID: NCT01754181
Acronym / sponsor ID: DiabeloopWP6-0 / 2012-A01489-34
Conditions: Type 1 Diabetes
Keywords: Glycemic control algorithm, closed loop, artificial pancreas
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
Study start: Mar 2013
Primary completion: Jun 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 21 Dec 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.

Detailed description

Grenoble and Toulouse will test the prandial algorithm with several carbohydrate intake and a primer of 50% or 75% of the total bolus. Groups of patients are described as follows:
Group I: patients have a meal with the usual carbohydrate intake. The meal bolus is made according to the current treatment.
Group II: patients have a meal with a "low" carbohydrate intake (50% reduction of carbohydrate).
Group III: patients have a meal with a "strong" carbohydrate intake (increase 50% of carbohydrate).
Group IV: patients of group IV have each meal with carbohydrate intake but their usual bolus will be omitted.
Inclusion visit V1: The study will be proposed at the patients who meet the inclusion criteria. After signing the consent, the investigator shall designate one group for each patient.
Visit V2 (24 hours before the visit V3): Installation, calibration and education of two glucose sensors dexcom G4 ™ will be performed by a nurse. The patient will keep two sensors until the end of the study (end of V4).
Visit V3 (algorithm test): Patient will be fitted with its insulin pump and the two sensors dexcom G4 ™. These will be coupled by the engineer LETI to the computer on which is installed the control algorithm to be tested. Lunch will be taken at 1 pm. The algorithm will provide proposals insulin every 15 minutes until 6 pm.
Visit V4 (patient control): Patient will be fitted with two sensors dexcom G4 ™ and its insulin pump programmed according to the usual algorithm. The meal will be taken at 1h PM. Patient can leave the site at 6 pm after removal of sensors.
CHSF (Centre Hospitalier Sud Francilien) will test the algorithm glycemic control during physical activity of moderate (50% VO2max) or high intensity (75% VO2max) for 30 minutes on a bicycle ergometer. In different situations, three patient groups will be created:
Group A: Patients practice an "average" physical activity(50% VO2max) with usual temporary basal reduction (usually 50% of reduction during the test and 2h next).
Group B: Patients practice an "intense" physical activity (75% VO2max) with usual temporary basal reduction (usually 80% of reduction during the test and 2h after).
Group C: patients practice an "average" physical activity (50% VO2max) but without concomitant reduction of temporary basal.
Inclusion visit V1 : The study will be proposed at the patients who meet the inclusion criteria. After signing the consent, the investigator shall designate one group for each patient.
Visit V2 : Patient will be equipped with two sensors dexcom G4 ™ and a heart rate monitor. Calibrated meal is expected at 11h 30 pm. The patient will be administered his insulin dose according to his usual algorithm. The physical test will begin three hours after the meal. It will be carried on bicycle ergometer for 30 minutes at an medium or high intensity. (Average = 50% VO2max, or high level = 75% VO2max).
Visit V3: The same test is repeated for each patient during this visit. Its insulin pump will be controlled by the doses proposal of the algorithm after manual validation by the investigator. These will continue until the next morning, and the patient will spend overnight in the hospital.

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Proposed treatment by Diabeloop algorithm	Experimental	Drug: Insulinthe insulin 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.
usual treatment	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Patients with type 1 diabetes treated by external insulin pump;
Patients with HbA1c <8.5%.
Patients aged 18 years or less;
Patient who signed consent;
Patient affiliated with Social Security.

Key exclusion criteria (3 listed)

Patients with type 2 diabetes
All serious diseases that could interfere with the study
Insulin resistance and obesity (BMI> 30 kg/m2 and / or insulin requirements> 2 U / kg / day)

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
Insulinthe intervention is applied only at the dose of insulin	Drug	Proposed treatment by Diabeloop algorithm

Primary outcome

Time spent in glucose reference intervals
Time frame: After the end of the tests

1 secondary outcome

Measuring glucose sensor 2h, 3h and 4h post-prandial and AUC, in every situation tested to evaluate the efficacy and safety (time spent in hypoglycemia)
Time frame: After the end of the tests

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

RecruitingPhase 4
Cholesterol Lowering and Residual Risk in Diabetes, Type 1
Type 1 Diabetes
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
RecruitingPhase 4
INfluenza VaccInation To Mitigate typE 1 Diabetes
Diabetes Mellitus, Type 1

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

Pierre-Yves BENHAMOU, Pr. principal investigator

CHU of Grenoble

Guillaume CHARPENTIER, MD study chair

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

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 Insulin 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 9 inclusion and 3 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 glucose reference intervals (time frame: After the end of the tests). 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 NCT01754181.

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.