Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2023-01-25
2024-05-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Diabeloop closed-loop glucose control session with the declaration of meals
Diabeloop software (an MPC-based glucose control algorithm) running on handset associated with the six-generation glucose sensor (Dexcom G6) and MEDISAFE WITH insulin pump.
Subjects are asked to declare their meals for 4 weeks.
A remote monitoring system is provided in closed-loop session.
Dexcom G6 Continuous Glucose Monitoring
Collection of glucose data
MEDISAFE WITH External Insulin Pump
Insulin delivery
Diabeloop Software (Model predictive control)
Diabeloop software embeds a regulation algorithm to automatically regulate the patient's glycaemia. It takes as input glycaemia value received every 5 minutes from the CGM and patient inputs related to meals and physical activities and it calculates the amount of insulin to be delivered. It sends this information to the pump that automatically delivers this quantity.
Declaration of meals
Patient inputs related to meals
Remote monitoring (Telemedicine)
Remote follow up by care health providers team
Diabeloop closed-loop glucose control session without the declaration of meals
Diabeloop software (an MPC-based glucose control algorithm) running on handset associated with the six-generation glucose sensor (Dexcom G6) and MEDISAFE WITH insulin pump.
Subjects are asked to not declare their meals for 4 weeks.
A remote monitoring system is provided in closed-loop session.
Dexcom G6 Continuous Glucose Monitoring
Collection of glucose data
MEDISAFE WITH External Insulin Pump
Insulin delivery
Diabeloop Software (Model predictive control)
Diabeloop software embeds a regulation algorithm to automatically regulate the patient's glycaemia. It takes as input glycaemia value received every 5 minutes from the CGM and patient inputs related to meals and physical activities and it calculates the amount of insulin to be delivered. It sends this information to the pump that automatically delivers this quantity.
No declaration of meals
No patient inputs related to meals
Remote monitoring (Telemedicine)
Remote follow up by care health providers team
Interventions
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Dexcom G6 Continuous Glucose Monitoring
Collection of glucose data
MEDISAFE WITH External Insulin Pump
Insulin delivery
Diabeloop Software (Model predictive control)
Diabeloop software embeds a regulation algorithm to automatically regulate the patient's glycaemia. It takes as input glycaemia value received every 5 minutes from the CGM and patient inputs related to meals and physical activities and it calculates the amount of insulin to be delivered. It sends this information to the pump that automatically delivers this quantity.
Declaration of meals
Patient inputs related to meals
No declaration of meals
No patient inputs related to meals
Remote monitoring (Telemedicine)
Remote follow up by care health providers team
Eligibility Criteria
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Inclusion Criteria
* Subject has a clinical diagnosis of type 1 diabetes for at least 1 year as determined via medical records or source documentation by an individual qualified to make a medical diagnosis or confirmed C peptide negative.
* An insulin pump user, or patient under Multiple Daily Injection (MDI), with or without CGM experience.
* Subject having a Glycosylated hemoglobin (HbA1c) blood value \> 8 % at time of screening visit-based on analysis from local laboratory within 3 months.
* Living in an area covered by a GSM (Global System for Mobile Communications) network
* Patient not isolated, does not live alone, or has a person living nearby who has a telephone and a key to his or her home
* Patient willing to wear the system continuously throughout the study
* Must be able to speak and be literate in French, in Dutch or in German
* Having provided written assent \& parents/guardian having provided written informed consent
Exclusion Criteria
* Patient having severe uncorrected problems of hearing and/or visual acuity
* Subject is unable to tolerate tape adhesive around the sensor or pump placements
* Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
* Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
* Is being treated for hyperthyroidism at time of screening
* Has diagnosis of adrenal insufficiency
* Has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the study
* Females who are sexually active and able to conceive will be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study as determined by investigator.
* Actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks
* Currently abusing illicit drugs
* Currently abusing marijuana
* Currently abusing prescription drugs
* Currently abusing alcohol
* Subject is using pramlintide (Symlin), DDP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening
* Subject has elective surgery planned that requires general anesthesia during the study
* Has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
* Plans to receive red blood cell transfusion or erythropoietin over study participation
* Diagnosed with current eating disorder such as anorexia or bulimia
* Diagnosed with chronic kidney disease that results in chronic anemia
* Hematocrit that is below the normal reference range of lab used
* Patient who has had a pancreatectomy or who has pancreatic malfunctions
* Patient with pancreatic islet transplantation or pancreas transplantation
* Patient on dialysis
* Patient with impaired hepatic functions
* Serum creatinine \> 176 µmol/L
* Any other physical or psychological disease, or medication likely to interfere with the conduct of the study and interpretation of the study results as judged by the investigator.
* Pregnancy or breastfeeding
* Untreated coeliac disease (2 x ULN local laboratory)
* Untreated or unstable thyroid disease
* Subject has a history of 2 or more episodes of severe hypoglycemia, which resulted in any of the following during the 6 months prior to screening:
* Medical assistance (i.e. Paramedics, Emergency Room or Hospitalization)
* Coma
* Seizures
* Subject having severe diabetic ketoacidosis in the 6 months prior to screening visit
* Impaired awareness of hypoglycemia (Gold Score \> 4)
12 Years
17 Years
ALL
No
Sponsors
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Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
OTHER
Responsible Party
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Principal Investigators
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Jacques Beltrand
Role: PRINCIPAL_INVESTIGATOR
Necker Hospital
Locations
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University Hospitals Leuven
Leuven, , Belgium
Necker Hospital
Paris, , France
Diabetes Center for Children and Adolescents Auf Der Bult
Hanover, , Germany
Countries
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Other Identifiers
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2020-A02132-37
Identifier Type: -
Identifier Source: org_study_id
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