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

Diabetes Mellitus, Type 1 Clinical Trial

— WP7  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02987556
• Other study ID #: 2016-A01198-43
• Status: Completed
• Phase: N/A
• Start date: March 30, 2017
• Est. completion date: August 28, 2018

Study information

• Verified date: May 2018
• Source: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: August 28, 2018
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Closed Loop
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• Continuous Glucose Monitoring
Collection of glucose data
• External Insulin Pump
insulin delivery

Other:
• telemdecine
Remote follow up by care health providers team

Device:
• 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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire Jean Minjoz	Besancon
France	Centre Hospitalier Universitaire	Caen
France	Centre Hospitalier Sud-Francilien	Corbeil-Essonnes
France	Centre Hospitalier Universitaire	Grenoble
France	Centre Hospitalier Universitaire	Lyon
France	Centre Hospitalier Universitaire	Marseille
France	Centre Hospitalier Universitaire	Montpellier
France	Centre Hospitalier Universitaire	Nancy
France	Centre Hospitalier Universitaire	Nantes
France	Centre Hospitalier Universitaire	Reims
France	Centre Hospitalier Universitaire	Strasbourg
France	Centre Hospitalier Universitaire	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time spent in the tight glycemic control area 70-180 mg/dl continuously measured for 12 weeks	measurement of glucose by CGM	For 12 weeks
Secondary	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	During 24 hours for 12 weeks
Secondary	Measurement of HbA1c at the onset and at the end of each period of treatment	Dosage of HbA1c every 3 months	During 12 weeks for each period of treatment
Secondary	Average blood glucose levels throughout the full period	measurement of glucose by CGM	During 12 weeks for each period of treatment
Secondary	Calculated risks of hypo- and hyperglycemia (LBGI, HBGI) throughout the full period during 12 weeks	measurement of glucose by CGM	Throughout the full period during 12 weeks
Secondary	Total supplies of insulin during tests	total basal and bolus by 24h	During 12 weeks for each period
Secondary	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	During 12 weeks for each period
Secondary	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	During 12 weeks for each period
Secondary	Measuring the oral carbohydrates intake during the last week of each period of treatment	data collected on a booklet	During 24 hours for one week before the end of each period of treatment
Secondary	Number of technical problems causing interruptions of the closed loop	technical incidents data collected during the study	During 12 weeks for the closed loop period
Secondary	Percentage of time spent in good-working mode during the closed loop period	measurement of glucose by CGM	During 12 weeks for the closed loop period
Secondary	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.	During 12 weeks at the end of each period of treatment
Secondary	Percentage of time spent in blood glucose <70 mg/dl continuously measured for 12 weeks	measurement of glucose by CGM	For 12 weeks