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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Collection of glucose data
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.
University Hospitals Leuven
Leuven, Belgium
Necker Hospital
Paris, France
Diabetes Center for Children and Adolescents Auf Der Bult
Hanover, Germany
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
Time frame: 2 weeks
Incidence of severe hypoglycemia as defined by the ISPAD guidelines:
* 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.
Time frame: 10 weeks
• Number of severe hyperglycemia episodes with beginning and end episode as measured by the Dexcom G6 CGM
o \>19.4 mmol/L or significant ketosis (plasmatic ketones \> 3 mmol/L) as defined by the ADA.
Time frame: 10 weeks
• Incidence of severe hyperglycemia
o Number of events requiring an emergency room visit or hospitalizations because of ketoacidosis (i.e. incidence of DKA)
Time frame: 10 weeks
• Percent of CGM time with glucose < 3.9 mmol/L
Measurement of glucose by CGM
Time frame: 10 weeks
• Percent of CGM time in glucose range 3.9-10.0 mmol/L
Measurement of glucose by CGM
Time frame: 10 weeks
• Mean CGM glucose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Patient inputs related to meals
No patient inputs related to meals
Remote follow up by care health providers team
Measurement of glucose by CGM
Time frame: 10 weeks
• 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
* \< 2.8 mmol/L * \< 3.0 mmol/L * \< 3.3 mmol/L * \< 3.9 mmol/L
Time frame: 24 hours
• Number of hypoglycemic episodes with beginning and end of episode as measured by the Dexcom G6 CGM for at least 15 minutes
* \< 3.9 mmol/L * \< 3.0 mmol/L * ≤ 2.8 mmol/L
Time frame: 10 weeks
• 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
* \> 10.0 mmol/L * \> 13.9 mmol/L * \> 16.7 mmol/L * \> 19.4 mmol/L
Time frame: 24 hours
• Number of severe hyperglycemia episodes with beginning and end of episode as measured by the Dexcom G6 CGM
o \> 19.4 mmol/L
Time frame: 10 weeks
• Number of serious adverse events, serious adverse device events, unanticipated adverse device effects
Time frame: 10 weeks
• Risk of hypoglycemia and hyperglycemia (LBGI/HBGI)
Measurement of glucose by CGM
Time frame: 10 weeks
• 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
Measurement of glucose by CGM
Time frame: 2 weeks
• 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
Measurement of glucose by CGM
Time frame: 24 hours
• 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
Measurement of glucose by CGM
Time frame: 24 hours
• 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
Measurement of glucose by CGM
Time frame: 24 hours
• Evolution of HbA1c calculated from CGM data
Measurement of glucose by CGM
Time frame: 10 weeks
• Average CGM glucose level during the entire period
Measurement of glucose by CGM
Time frame: 10 weeks
• Average fasting CGM glucose level at 6:00 am
Measurement of glucose by CGM
Time frame: 10 weeks
• Variability of the CGM glucose level
* the glycemic variation coefficient (CV) intra patient: CV \< 36% CV ≥ 36% * Standard deviation (SD)
Time frame: 10 weeks
• Average dose of insulin used & its daily evolution during the entire study duration
Time frame: 10 weeks
• Number of technical incidents leading to the interruption of the closed loop
Time frame: 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
Measurement of glucose by CGM
Time frame: 8 weeks
• Evolution of the weekly average number of CHO intake (for patient with closed-loop)
Time frame: 8 weeks
• Percentage of time spent in closed loop mode (i.e. DBL System with loop mode operating)
Time frame: 8 weeks
• Percentage of time spent in operating mode for the Dexcom G6 CGM
Time frame: 10 weeks
• Scoring of a questionnaire to evaluate the acceptance
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).
Time frame: 10 weeks
• Scoring of a questionnaire to evaluate the acceptance
o Diabetes Technology Questionnaire (DTQ) aims to evaluate the impact of the closed-loop system use and diabetes specific quality of life measures in the study participants and their families, as well as satisfaction of system, as compared to conventional treatment options. The subject will answer by choosing from 5 suggestions : Strongly agree - Agree - Neither agree nor disagree - Disagree - Strongly disagree.
Time frame: 10 weeks