DBLHU
In Adults With Very Unstable Type 1 Diabetes, is the DBLHU Closed-Loop Insulin Delivery System Able to Improve Blood Glycemic Control Compared to Low-Glucose-Predictive-Suspend System: Two-center, Randomized, Open-label Study
Sponsor study identifier
interventional
7
1 country
2
Study Start
September 3, 2019
Actual (reported)Primary Completion
February 27, 2020
Actual (reported)Study Completion
March 22, 2021
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 22, 2021
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 19, 2019
Actual (reported)August 1, 2019
Actual (reported)September 3, 2019
Actual (reported)February 27, 2020
Actual (reported)March 22, 2021
Actual (reported)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
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
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.
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.
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
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
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.
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
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
consists of sensor-augmented pump therapy (SAP) / Low Glucose Predictive Suspend system (with predictive low glucose management technology)
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.
Grenoble Alpes University Hospital
Grenoble, 38700, France
Lille University Hospital
Lille, 59037, France
Pierre Yves BENHAMOU, Pr
University Hospital, Grenoble
7 participants (actual enrollment reported by the registry).
First Submitted
July 19, 2019
First Posted
August 1, 2019
Study Start
September 3, 2019
Actual (reported)Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 27, 2020
Actual (reported)Study Completion
March 22, 2021
Actual (reported)Last Updated
May 10, 2021
Record last verified: 2020-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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