Adolescents (12 to 17 Years Old), Closed Loop, Diabetes Mellitus, Type 1
Conditions
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.
Interventions
DEVICEDexcom G6 Continuous Glucose Monitoring
Collection of glucose data
DEVICEMEDISAFE WITH External Insulin Pump
Insulin delivery
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.
OTHERDeclaration of meals
Patient inputs related to meals
OTHERNo declaration of meals
No patient inputs related to meals
Remote follow up by care health providers team
Sponsors
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Device-related inclusion criteria * age 12 - \<18 years (i.e 17 years and 364 days) at time of screening * Type 1 diabetes Study-specific 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
Device-related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 2 weeks | Measurement of glucose by CGM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| • Number of severe hyperglycemia episodes with beginning and end episode as measured by the Dexcom G6 CGM | 10 weeks | o \>19.4 mmol/L or significant ketosis (plasmatic ketones \> 3 mmol/L) as defined by the ADA. |
| • Incidence of severe hyperglycemia | 10 weeks | o Number of events requiring an emergency room visit or hospitalizations because of ketoacidosis (i.e. incidence of DKA) |
| • Percent of CGM time with glucose < 3.9 mmol/L | 10 weeks | Measurement of glucose by CGM |
| • Percent of CGM time in glucose range 3.9-10.0 mmol/L | 10 weeks | Measurement of glucose by CGM |
| • Mean CGM glucose | 10 weeks | Measurement of glucose by CGM |
| • Percentage of sensor time in glucose level measured by the Dexcom G6 CGM, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am | 24 hours | * \< 2.8 mmol/L * \< 3.0 mmol/L * \< 3.3 mmol/L * \< 3.9 mmol/L |
| • Number of hypoglycemic episodes with beginning and end of episode as measured by the Dexcom G6 CGM for at least 15 minutes | 10 weeks | * \< 3.9 mmol/L * \< 3.0 mmol/L * ≤ 2.8 mmol/L |
| • Number of severe hyperglycemia episodes with beginning and end of episode as measured by the Dexcom G6 CGM | 10 weeks | o \> 19.4 mmol/L |
| • Number of serious adverse events, serious adverse device events, unanticipated adverse device effects | 10 weeks | — |
| • Risk of hypoglycemia and hyperglycemia (LBGI/HBGI) | 10 weeks | Measurement of glucose by CGM |
| • Percentage of time spent in the 3.9-10.0 mmol/L target range, for the last 2 weeks of each cross-over session during nights, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am | 2 weeks | Measurement of glucose by CGM |
| • Percentage of sensor time in glucose range 2.8 - 3.9 mmol/L, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am | 24 hours | Measurement of glucose by CGM |
| Incidence of severe hypoglycemia as defined by the ISPAD guidelines: | 10 weeks | * Number of severe hypoglycemic episodes needing a third-party intervention * Number of severe hypoglycemic episodes with loss of consciousness * Number of hospitalizations because of a severe hypoglycemia episode * Number of hypoglycemic episodes, defined by any crossing of the threshold of 3.33 mmol/L, 3.9 mmol/L, 3.0mmol/L and \< 2.8 mmol/L measured continuous glucose monitoring. |
| • Percentage of sensor time in glucose range 3.9 - 10.0 mmol/L, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am | 24 hours | Measurement of glucose by CGM |
| • Evolution of HbA1c calculated from CGM data | 10 weeks | Measurement of glucose by CGM |
| • Average CGM glucose level during the entire period | 10 weeks | Measurement of glucose by CGM |
| • Average fasting CGM glucose level at 6:00 am | 10 weeks | Measurement of glucose by CGM |
| • Variability of the CGM glucose level | 10 weeks | * the glycemic variation coefficient (CV) intra patient: CV \< 36% CV ≥ 36% * Standard deviation (SD) |
| • Average dose of insulin used & its daily evolution during the entire study duration | 10 weeks | — |
| • Number of technical incidents leading to the interruption of the closed loop | 8 weeks | — |
| • Evolution over time of the DBL system's performance on a day-to-day and determination of the optimization delay of glycemic control | 8 weeks | Measurement of glucose by CGM |
| • Evolution of the weekly average number of CHO intake (for patient with closed-loop) | 8 weeks | — |
| • Percentage of time spent in closed loop mode (i.e. DBL System with loop mode operating) | 8 weeks | — |
| • Percentage of time spent in operating mode for the Dexcom G6 CGM | 10 weeks | — |
| • Scoring of a questionnaire to evaluate the acceptance | 10 weeks | o Diabetes Treatment Satisfaction Questionnaire (DTSQ) is a 12-item measure that enables self-reporting of the satisfaction about their current treatment. Scale is from 6 (very satisfied) to 0 (very dissatisfied). |
| • Percentage of sensor time in glucose range 3.9 - 7.8 mmol/L, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am | 24 hours | Measurement of glucose by CGM |
Countries
Belgium, France, Germany
Outcome results
None listed