An interventional study of Low Glucose Predictive Suspend system and DBLHU System in Diabetes Mellitus, Type 1, Diabetes Mellitus, Brittle and Closed-Loop, sponsored by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète. Completed at 2 sites in France. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2021-05-10.
Sponsored by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète · Not applicable, Interventional, and Device feasibility
Feasibility study, comparing experimental treatment (DBLHU closed-loop system) with reference treatment (Low Glucose Predictive Suspend system) in 7 patients going through a series of N-of-1 trials. Each N-of-1 trial consists in a prospectively planned, multiple crossover study in a single individual. Two blocks of two periods of four weeks each (closed loop or open loop) will be conducted. Within each block, the sequence closed loop-open loop or open loop-close loop is randomized. Outcomes will be analyzed on the third and fourth weeks of period.
A remote monitoring system managed by specialized nurse on behalf of diabetologist, is provided in closed-loop session.
An extension period of 48 weeks with the DBLHU System (closed-loop condition) will be performed at the end of the crossover study phase in real life conditions (without remote monitoring).
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 7 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète is the lead sponsor of 31 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subject that had experienced, despite optimal diabetes management and prior to any equipment with Smartguard technology, glucose instability as defined by at least 2 of the following criteria which would have led to eligibility for pancreatic islet transplantation:
Exclusion Criteria:
Sensor-augmented pump therapy (SAP) namely the Low Glucose Predictive Suspend system or LGPS and a blinded glucose sensor (Dexcom G6) followed by a 48-week extension period in closed-loop condition
Device: Low Glucose Predictive Suspend system · Device: DBLHU System
DBLHU software (a Model Predictive Control \[MPC\]-based glucose control algorithm) running on handset associated with the six-generation glucose sensor (Dexcom G6) and Kaleido insulin pump followed by a 48-week extension period in closed-loop condition
Device: DBLHU System
consists of sensor-augmented pump therapy (SAP) / Low Glucose Predictive Suspend system (with predictive low glucose management technology)
Also known as: Open-loop condition
DBLHU system 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.
Also known as: Closed-loop condition
Percentage of CGM time in glucose range 70-180 mg/dl, during 24 hours periods for the third and fourth week for each treatment period
Measured by continuous glucose monitoring
Time frame: 14 days for each treatment period
Evolution over time of the DBLHU system's performance on a day-to-day and determination of the optimization delay of glycemic control
Measured by continuous glucose monitoring
Time frame: Over twenty-four hour periods on the four weeks of each treatment period and of the 24-week and 48-week extented CL period.
Percent of CGM time in glucose range 70-180 mg/dl during nighttime.
Measured by continuous glucose monitoring
Time frame: Overnight (defined as 00:00 to 06:00) periods on the third and fourth week of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.
Percent of CGM time in glucose range 70-180 mg/dl during daytime.
Measured by continuous glucose monitoring
Time frame: Over daytime (defined as 06:00 to 00:00) periods on the third and fourth week of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.
Percent of CGM time with glucose < 70mg/dl, < 60mg/dl, < 54mg/dl and < 50mg/dl
Measured by continuous glucose monitoring
Time frame: Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.
Percent of CGM time with glucose > 180mg/dl, > 250mg/dl, > 300mg/dl and > 360mg/dl
Measured by continuous glucose monitoring
Time frame: Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.
Average glycemia level
Measured by continuous glucose monitoring
Time frame: Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.
Estimated HbA1c (eHbA1c) levels / glucose management indicator (GMI)
Measured by continuous glucose monitoring
Time frame: Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.
HbA1c levels
Measured by blood sampling
Time frame: HbA1c value at the week 24 and week 48 of extented CL period.
Glucose coefficient of variation (CV) and Standard deviation (SD)
Measured by continuous glucose monitoring
Time frame: Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.
Rate of CGM excursions below 54 mg/dl (3.0 mM) for at least 15 min
Mean time spent in hypoglycaemia, defined as sensor glucose values of 54 mg/dL (3∙0 mmol/L) or lower for more than 15 min consecutively
Time frame: Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.
Comparison of MAGE index and Low Blood Glucose Index (LBGI)
Mean amplitude of glucose excursions and Low Glucose index as measured by continuous glucose monitoring
Time frame: Over twenty-four hour periods on the third and fourth weeks of each treatment period and during 24-week extension period
Number of acute metabolic events (severe hypoglycemia, severe Diabetic Ketoacidosis [DKA])
Measured by continuous glucose monitoring. Number of severe hypoglycemia is defined as any event requiring third party assistance. DKA events. Subjects will be asked to measure blood ketone levels on if their interstitial glucose is above 300 mg/l beyond the usual timeframe following a meal, as part of the safety evaluation for hyperglycemia.
Time frame: During 4 weeks of each treatment period and during 24-week and 48-week extension period
Number of severe hypoglycemia with loss of consciousness
Number of severe hypoglycemia with loss of consciousness
Time frame: During 4 weeks of each treatment period and during 24-week and 48-week extension period
Number of hospitalizations for severe hypoglycemia or ketoacidosis
Number of hospitalizations
Time frame: During 4 weeks of each treatment period and during 24-week and 48-week extension period
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.
Time frame: after baseline period (2-week); after crossover period; after 24-week and after 48-week extension period
Percentage of CGM time in glucose range 70-180 mg/dl, during 24 hours periods
Measured by continuous glucose monitoring
Time frame: 24-week and 48-week extension period
Plan to share: No
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Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète