Closed LoopWP7NCT02987556

Diabeloop WP7 : Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop (WP7)

A study testing Continuous Glucose Monitoring, External Insulin Pump and telemdecine in people with Closed Loop and Diabetes Mellitus, Type 1, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 12 sites in France.

Completed

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

Official record

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Trial summary

The study will be conducted in crossover trial, with two 12-weeks periods separated by a Wash-out period of at least one month. According to randomization ,patients will be provided with either Diabeloop system or the usual system. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Closed Loop, Diabetes Mellitus, Type 1
What is being tested?: Continuous Glucose Monitoring, External Insulin Pump and telemdecine
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 12 sitesFrance
Study dates: 30 Mar 2017to 28 Aug 2018
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 for at least two years
Patient treated by external insulin pump for at least 6 months
Patient with HbA1c ≤ 10%; dosage of less than 4 months done in analysis laboratory medical or equivalent.
Patient requiring a daily dose of insulin ≤ 50 units
Patient domiciled in an area with Global System for Mobile Communication (GSM)
Not isolated patient, not living alone, or having a person "resource" living nearby and having a phone and the key of its place of residence

Show all 10Show fewer

Patient not envisaging a journey outside France during the "closed-loop" period
Patient aged over 18 years
Patient affiliated to Social Security
Patient who agreed to participate in the study and who signed an informed consent

Who cannot join

Patient with any serious illness that may impair study participation
Patient having a treatment known to have a significant interference on the glycemia.
Patient enjoying a measure of legal protection
Pregnant woman or likely to be

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

France12 sites

Centre Hospitalier Universitaire Jean Minjoz
Besançon, 25030
Centre Hospitalier Universitaire
Caen, 14033
Centre Hospitalier Sud-Francilien
Corbeil-Essonnes, 91100
Centre Hospitalier Universitaire
Grenoble, 38700
Centre Hospitalier Universitaire
Lyon, 69000
Centre Hospitalier Universitaire
Marseille, 13000
Centre Hospitalier Universitaire
Montpellier, 34295
Centre Hospitalier Universitaire
Nancy, 54000
Centre Hospitalier Universitaire
Nantes, 44000
Centre Hospitalier Universitaire
Reims, 51100
Centre Hospitalier Universitaire
Strasbourg, 67000
Centre Hospitalier Universitaire
Toulouse, 31400

Other trials in France

About this study

Official title: Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop for Three Months at Home in Comparison With Conventional Treatment by External Insulin Pump in Patients With Type 1 Diabetes.

Patients will be trained for the use of blood glucose meter, of external Insulin Pump and Diabeloop system.

In both treatment periods, the same blood glucose meter will be used throughout the duration of the study.

In two centers (Centre Hospitalier Sud-Francilien and Grenoble), a pre-study will be performed during four weeks to improve the efficacy of Diabeloop system with data collection, to test the manual settings by health care providers and patients and to check the good-working of the follow-up platform.

Conditions: Closed Loop, Diabetes Mellitus, Type 1
Being tested: Continuous Glucose Monitoring, External Insulin Pump, telemdecine, The Diabeloop Software (Model predictive control)
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.

Continuous Glucose MonitoringDevice
Collection of glucose data
External Insulin PumpDevice
insulin delivery
telemdecineOther
Remote follow up by care health providers team
The Diabeloop Software (Model predictive control)Device
Diabeloop is a Closed-loop (CL) system with a Model Predictive Control (MPC) algorithm reinforced by a decisional matrix, uploaded on a dedicated android smartphone linked to Dexcom CGM and a Cellnovo or Kaleido insulin patch-pump. The Diabeloop software calculates the insulin dose according to the patient's needs.

Study groups in NCT02987556
Study group	Role	What they receive
Usual System (open-loop)	Active comparator	In open loop, patients will be provided with an Continuous Glucose Monitoring (CGM) and an external insulin pump programmed with its usual treatment previously prescribed by its physician. Receives: Device: Continuous Glucose Monitoring; Device: External Insulin Pump
DIABELOOP System (closed-loop)	Experimental	In the closed-loop, patients will be provided with the Diabeloop system consisting of insulin pump Cellnovo or Kaleido driven by remote control augmented by Diabeloop software and connected to the CGM Prescription of insulin doses proposed by a predictive algorithm. Receives: Device: Continuous Glucose Monitoring; Device: External Insulin Pump; Other: telemdecine; Device: The Diabeloop Software (Model predictive control)

What is being measured

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

Percentage of time spent in the tight glycemic control area 70-180 mg/dl continuously measured for 12 weeks
measurement of glucose by CGM
Measured: For 12 weeks

Secondary outcomes (12)

Percentage of time spent in the glycemic range 70-180 mg/dl, 80-140 mg/dl and in blood glucose >180 mg/dL during nights and during 24 hours for 12 weeks
measurement of glucose by CGM
Measured: During 24 hours for 12 weeks
Measurement of HbA1c at the onset and at the end of each period of treatment
Dosage of HbA1c every 3 months
Measured: During 12 weeks for each period of treatment
Average blood glucose levels throughout the full period
measurement of glucose by CGM
Measured: During 12 weeks for each period of treatment
Calculated risks of hypo- and hyperglycemia (LBGI, HBGI) throughout the full period during 12 weeks
measurement of glucose by CGM
Measured: Throughout the full period during 12 weeks
Total supplies of insulin during tests
total basal and bolus by 24h
Measured: During 12 weeks for each period
Number of hyper-glycemic events defined by American Diabetes Association (ADA) : severe hyperglycemia > 360 mg/dl (20 mmol/l) measured by CGM or significant ketose (acetonemia > 3 mmol/l)
measurement of glucose by CGM
Measured: During 12 weeks for each period
Number of hypoglycemic events, defined by any threshold crossing 60 mg/dl ( 3,33 mmol/l); 70 mg/dl (3,9 mmol/l) and < 54 mg/dl (3 mmol/l) measured by the CGM
measurement of glucose by CGM
Measured: During 12 weeks for each period
Measuring the oral carbohydrates intake during the last week of each period of treatment
data collected on a booklet
Measured: During 24 hours for one week before the end of each period of treatment
Number of technical problems causing interruptions of the closed loop
technical incidents data collected during the study
Measured: During 12 weeks for the closed loop period
Percentage of time spent in good-working mode during the closed loop period
measurement of glucose by CGM
Measured: During 12 weeks for the closed loop period
For the use and the acceptance, a satisfaction survey will be done on the daily management of diabetes, the modification of daily life with the system dan the fear of hypoglycemia
DTSQ satisfaction questionnaire, with scale from 6 to 0 where 0 is the worth and 6 the best outcome.
Measured: During 12 weeks at the end of each period of treatment
Percentage of time spent in blood glucose <70 mg/dl continuously measured for 12 weeks
measurement of glucose by CGM
Measured: For 12 weeks

Timeline

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

30 Mar 201728 Aug 2018

First posted9 Dec 2016 (estimated)
Study start30 Mar 2017
Primary completion28 Aug 2018
Study completion28 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Closed LoopStudies 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: Crossover
Model description: Closed loop vs. Open loop,
Masking: None (open label)
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02987556
Sponsor's protocol ID: 2016-A01198-43
Acronym: WP7
Status last verified: May 2018
First submitted: 28 Nov 2016
Last updated: 1 Feb 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Benhamou PY, Adenis A, Tourki Y, Pou S, Madrolle S, Franc S, Kariyawasam D, Beltrand J, Klonoff DC, Charpentier G. Efficacy of a Hybrid Closed-Loop Solution in Patients With Excessive Time in Hypoglycaemia: A Post Hoc Analysis of Trials With DBLG1 System. J Diabetes Sci Technol. 2024 Mar;18(2):372-379. doi: 10.1177/19322968221128565. Epub 2022 Sep 29.
PubMed 36172702
Benhamou PY, Franc S, Reznik Y, Thivolet C, Schaepelynck P, Renard E, Guerci B, Chaillous L, Lukas-Croisier C, Jeandidier N, Hanaire H, Borot S, Doron M, Jallon P, Xhaard I, Melki V, Meyer L, Delemer B, Guillouche M, Schoumacker-Ley L, Farret A, Raccah D, Lablanche S, Joubert M, Penfornis A, Charpentier G; DIABELOOP WP7 Trial Investigators. Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial. Lancet Digit Health. 2019 May;1(1):e17-e25. doi: 10.1016/S2589-7500(19)30003-2. Epub 2019 May 2.
PubMed 33323237
Benhamou PY, Madrolle S, Lablanche S, Gallegos A, Tourki Y, Franc S, Doron M, Charpentier G. Comment on Leelarathna et al. Duration of Hybrid Closed-Loop Insulin Therapy to Achieve Representative Glycemic Outcomes in Adults With Type 1 Diabetes. Diabetes Care 2020;43:e38-e39. Diabetes Care. 2020 Oct;43(10):e167. doi: 10.2337/dc20-1291. No abstract available.
PubMed 32958628
Benhamou PY, Huneker E, Franc S, Doron M, Charpentier G; Diabeloop Consortium. Customization of home closed-loop insulin delivery in adult patients with type 1 diabetes, assisted with structured remote monitoring: the pilot WP7 Diabeloop study. Acta Diabetol. 2018 Jun;55(6):549-556. doi: 10.1007/s00592-018-1123-1. Epub 2018 Mar 9.
PubMed 29520615

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?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop for Three Months at Home in Comparison With Conventional Treatment by External Insulin Pump in Patients With Type 1 Diabetes.
ClinicalTrials.gov ID: NCT02987556
Acronym / sponsor ID: WP7 / 2016-A01198-43
Conditions: Closed Loop, Diabetes Mellitus, Type 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
Study start: 30 Mar 2017 (actual)
Primary completion: 28 Aug 2018 (actual)
Study completion: 28 Aug 2018 (actual)
First posted: 9 Dec 2016 (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.

Patients will be trained for the use of blood glucose meter, of external Insulin Pump and Diabeloop system.

In both treatment periods, the same blood glucose meter will be used throughout the duration of the study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Closed loop vs. Open loop,

Arm	Type	Receives
Usual System (open-loop)	Active comparator	Device: Continuous Glucose Monitoring, Device: External Insulin PumpIn open loop, patients will be provided with an Continuous Glucose Monitoring (CGM) and an external insulin pump programmed with its usual treatment previously prescribed by its physician.
DIABELOOP System (closed-loop)	Experimental	Device: Continuous Glucose Monitoring, Device: External Insulin Pump, Other: telemdecine, Device: The Diabeloop Software (Model predictive control)In the closed-loop, patients will be provided with the Diabeloop system consisting of insulin pump Cellnovo or Kaleido driven by remote control augmented by Diabeloop software and connected to the CGM Prescription of insulin doses proposed by a predictive algorithm.

Who may qualify

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

Key inclusion criteria (10 listed)

Type 1 diabetic patient for at least two years
Patient treated by external insulin pump for at least 6 months
Patient with HbA1c ≤ 10%; dosage of less than 4 months done in analysis laboratory medical or equivalent.
Patient requiring a daily dose of insulin ≤ 50 units
Patient domiciled in an area with Global System for Mobile Communication (GSM)

Key exclusion criteria (4 listed)

Patient with any serious illness that may impair study participation
Patient having a treatment known to have a significant interference on the glycemia.
Patient enjoying a measure of legal protection
Pregnant woman or likely to be

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
Continuous Glucose MonitoringCollection of glucose data	Device	DIABELOOP System (closed-loop), Usual System (open-loop)
External Insulin Pumpinsulin delivery	Device	DIABELOOP System (closed-loop), Usual System (open-loop)
telemdecineRemote follow up by care health providers team	Other	DIABELOOP System (closed-loop)
The Diabeloop Software (Model predictive control)Diabeloop is a Closed-loop (CL) system with a Model Predictive Control (MPC) algorithm reinforced by a decisional matrix, uploaded on a dedicated android smartphone linked to Dexcom CGM and a Cellnovo or Kaleido insulin patch-pump. The Diabeloop software calculates the insulin dose according to the patient's needs.	Device	DIABELOOP System (closed-loop)

Primary outcome

Percentage of time spent in the tight glycemic control area 70-180 mg/dl continuously measured for 12 weeks
Time frame: For 12 weeks
measurement of glucose by CGM

12 secondary outcomes

Percentage of time spent in the glycemic range 70-180 mg/dl, 80-140 mg/dl and in blood glucose >180 mg/dL during nights and during 24 hours for 12 weeks
Time frame: During 24 hours for 12 weeks
Measurement of HbA1c at the onset and at the end of each period of treatment
Time frame: During 12 weeks for each period of treatment
Average blood glucose levels throughout the full period
Time frame: During 12 weeks for each period of treatment
Calculated risks of hypo- and hyperglycemia (LBGI, HBGI) throughout the full period during 12 weeks
Time frame: Throughout the full period during 12 weeks
Total supplies of insulin during tests
Time frame: During 12 weeks for each period
Number of hyper-glycemic events defined by American Diabetes Association (ADA) : severe hyperglycemia > 360 mg/dl (20 mmol/l) measured by CGM or significant ketose (acetonemia > 3 mmol/l)
Time frame: During 12 weeks for each period
Number of hypoglycemic events, defined by any threshold crossing 60 mg/dl ( 3,33 mmol/l); 70 mg/dl (3,9 mmol/l) and < 54 mg/dl (3 mmol/l) measured by the CGM
Time frame: During 12 weeks for each period
Measuring the oral carbohydrates intake during the last week of each period of treatment
Time frame: During 24 hours for one week before the end of each period of treatment
Number of technical problems causing interruptions of the closed loop
Time frame: During 12 weeks for the closed loop period
Percentage of time spent in good-working mode during the closed loop period
Time frame: During 12 weeks for the closed loop period
For the use and the acceptance, a satisfaction survey will be done on the daily management of diabetes, the modification of daily life with the system dan the fear of hypoglycemia
Time frame: During 12 weeks at the end of each period of treatment
Percentage of time spent in blood glucose <70 mg/dl continuously measured for 12 weeks
Time frame: For 12 weeks

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 1 Feb 2019.
Derived from this study: PubMed 36172702Benhamou PY, Adenis A, Tourki Y, Pou S, Madrolle S, Franc S, Kariyawasam D, Beltrand J, Klonoff DC, Charpentier G. Efficacy of a Hybrid Closed-Loop Solution in Patients With Excessive Time in Hypoglycaemia: A Post Hoc Analysis of Trials With DBLG1 System. J Diabetes Sci Technol. 2024 Mar;18(2):372-379. doi: 10.1177/19322968221128565. Epub 2022 Sep 29.
Derived from this study: PubMed 33323237Benhamou PY, Franc S, Reznik Y, Thivolet C, Schaepelynck P, Renard E, Guerci B, Chaillous L, Lukas-Croisier C, Jeandidier N, Hanaire H, Borot S, Doron M, Jallon P, Xhaard I, Melki V, Meyer L, Delemer B, Guillouche M, Schoumacker-Ley L, Farret A, Raccah D, Lablanche S, Joubert M, Penfornis A, Charpentier G; DIABELOOP WP7 Trial Investigators. Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial. Lancet Digit Health. 2019 May;1(1):e17-e25. doi: 10.1016/S2589-7500(19)30003-2. Epub 2019 May 2.
Derived from this study: PubMed 32958628Benhamou PY, Madrolle S, Lablanche S, Gallegos A, Tourki Y, Franc S, Doron M, Charpentier G. Comment on Leelarathna et al. Duration of Hybrid Closed-Loop Insulin Therapy to Achieve Representative Glycemic Outcomes in Adults With Type 1 Diabetes. Diabetes Care 2020;43:e38-e39. Diabetes Care. 2020 Oct;43(10):e167. doi: 10.2337/dc20-1291. No abstract available.
Derived from this study: PubMed 29520615Benhamou PY, Huneker E, Franc S, Doron M, Charpentier G; Diabeloop Consortium. Customization of home closed-loop insulin delivery in adult patients with type 1 diabetes, assisted with structured remote monitoring: the pilot WP7 Diabeloop study. Acta Diabetol. 2018 Jun;55(6):549-556. doi: 10.1007/s00592-018-1123-1. Epub 2018 Mar 9.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 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 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 time spent in the tight glycemic control area 70-180 mg/dl continuously measured for 12 weeks (time frame: For 12 weeks). 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 NCT02987556, which also lists 4 linked publications.

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 1 Feb 2019.