Diabeloop for Teens

NCT04725591 | Completed

• 1 other identifier: 2020-A02132-37
• Study Type: interventional
• Target: 49
• Locations: 3 countries
• Sites: 3

Brief Summary

An open-label, three-centers, controlled, randomized, and crossover study containing 14 days of baseline period with standard of care (SOC) therapy followed by two-sessions of 4-weeks home study phase with Diabeloop closed-loop (CL) system comparing the declaration of meals and the non-declaration of meals.

Conditions

Closed Loop; Diabetes Mellitus, Type 1; Adolescents (12 to 17 Years Old)

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the time spent of the glucose level in the widened target range 3.9-10.0 mmol/L over the 2 last weeks of each cross-over period, as recorded by continuous subcutaneous glucose monitoring (CGM).

  Measurement of glucose by CGM

  2 weeks

Secondary Outcomes (28)

• Incidence of severe hypoglycemia as defined by the ISPAD guidelines:

  10 weeks

• • Number of severe hyperglycemia episodes with beginning and end episode as measured by the Dexcom G6 CGM

  10 weeks

• • Incidence of severe hyperglycemia

  10 weeks

• • Percent of CGM time with glucose < 3.9 mmol/L

  10 weeks

• • Percent of CGM time in glucose range 3.9-10.0 mmol/L

  10 weeks

Study Arms (2)

Diabeloop closed-loop glucose control session with the declaration of meals

ACTIVE COMPARATOR

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.

Device: Dexcom G6 Continuous Glucose Monitoring; Device: MEDISAFE WITH External Insulin Pump; Device: Diabeloop Software (Model predictive control); Other: Declaration of meals; Other: Remote monitoring (Telemedicine)

Diabeloop closed-loop glucose control session without the declaration of meals

EXPERIMENTAL

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.

Device: Dexcom G6 Continuous Glucose Monitoring; Device: MEDISAFE WITH External Insulin Pump; Device: Diabeloop Software (Model predictive control); Other: No declaration of meals; Other: Remote monitoring (Telemedicine)

Interventions

Dexcom G6 Continuous Glucose Monitoring DEVICE

Collection of glucose data

Diabeloop closed-loop glucose control session with the declaration of meals; Diabeloop closed-loop glucose control session without the declaration of meals

MEDISAFE WITH External Insulin Pump DEVICE

Insulin delivery

Diabeloop closed-loop glucose control session with the declaration of meals; Diabeloop closed-loop glucose control session without the declaration of meals

Diabeloop Software (Model predictive control) DEVICE

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.

Diabeloop closed-loop glucose control session with the declaration of meals; Diabeloop closed-loop glucose control session without the declaration of meals

Declaration of meals OTHER

Patient inputs related to meals

Diabeloop closed-loop glucose control session with the declaration of meals

No declaration of meals OTHER

No patient inputs related to meals

Diabeloop closed-loop glucose control session without the declaration of meals

Remote monitoring (Telemedicine) OTHER

Remote follow up by care health providers team

Diabeloop closed-loop glucose control session with the declaration of meals; Diabeloop closed-loop glucose control session without the declaration of meals

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age 12 - \<18 years (i.e 17 years and 364 days) at time of screening
• 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

You may not qualify if:

• Patient receiving a total daily dose of insulin lower than 8 U
• 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

Sponsors & Collaborators

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

Study Sites (3)

University Hospitals Leuven

Leuven, Belgium

Location

Necker Hospital

Paris, France

Location

Diabetes Center for Children and Adolescents Auf Der Bult

Hanover, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Jacques Beltrand

  Necker Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 26, 2021
• Study Start: January 25, 2023
• Primary Completion: February 14, 2024
• Study Completion: May 19, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

FR (1); DE (1); BE (1)