Diabeloop for Highly Unstable Type 1 Diabetes (DBLHU)

May 7, 2021 updated by: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38700
        • Grenoble Alpes University Hospital
      • Lille, France, 59037
        • Lille University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject (aged 22 or more) with Type 1 diabetes for at least 5 years and confirmed C peptide negative
  • Treated with continuous subcutaneous insulin infusion (CSII) for ≥ 6 months,
  • Trained to carbohydrate counting/flexible insulin therapy,

  • 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:

    • occurrence of at least 1 severe hypoglycemic episode during the past 12 months (need for third party),
    • occurrence of ketoacidosis (hospitalization in ICU) without explanation
    • Impaired awareness of hypoglycemia (Clark Score ≥ 4; Gold Score > 4)
    • glucose levels: standard deviation > 50% of the arithmetic mean value on glucose meter or > 40 mg/dl on CGM on a 14-day recording
    • glucose levels: MAGE (mean amplitude of glucose excursions) index > 60 mg/dl
    • glucose levels: coefficient of variation (CV) > 36%
  • with persisting extreme glucose variability despite optimal medical care
  • with contra-indication or no agreement to undertake pancreatic islet transplantation or pancreas transplantation.
  • Subject willing to wear the DBLHU system continuously throughout the study

Exclusion Criteria:

  • patient with type 2 diabetes
  • age < 22 years old
  • patient without any social or familial support able to intervene in case of severe hypoglycemic event
  • any permanent and severe condition able to interact with the normal course of the study
  • patient with insulin-resistance defined by insulin requirements > 1.5U/kg/d
  • patient with a daily dose of insulin required greater than 90 units
  • patient receiving a total daily dose of insulin less than 8 U
  • use of any insulin that is not 100 U/mL fast-acting insulin analog
  • patient suffering from a serious illness or a treatment that might significantly impair diabetes physiology, i.e. glucose-insulin interactions, that might interfere with the medical device (for example irregular treatment of steroids)
  • patient having severe problems of uncorrected hearing and/or visual acuity
  • patient who is unable to understand and perform all the instructions provided by Diabeloop SA
  • patient not willing to perform ≥4 finger stick blood glucose measurements daily
  • patients that have frequent exposure to magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment.
  • patient who has had a pancreatectomy or who has pancreatic malfunctions
  • patient having severely altered renal function (Creatinine clearance < 30ml/min)
  • patient on dialysis
  • pregnancy or breast-feeding patient, or project of pregnancy during the next 6 months
  • lack of effective contraception in women of childbearing potential
  • all conditions excluding participation to clinical research as defined in France

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Reference treatment (Open-Loop)
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
consists of sensor-augmented pump therapy (SAP) / Low Glucose Predictive Suspend system (with predictive low glucose management technology)
Other Names:
  • Open-loop condition
Device: DBLHU System
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.
Other Names:
  • Closed-loop condition
EXPERIMENTAL: DBLHU system (Closed-Loop)
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
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.
Other Names:
  • Closed-loop condition

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 14 days for each treatment period
Measured by continuous glucose monitoring
14 days for each treatment period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evolution over time of the DBLHU system's performance on a day-to-day and determination of the optimization delay of glycemic control
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.
Measured by continuous glucose monitoring
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.
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.
Measured by continuous glucose monitoring
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.
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.
Measured by continuous glucose monitoring
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
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.
Measured by continuous glucose monitoring
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
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.
Measured by continuous glucose monitoring
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
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.
Measured by continuous glucose monitoring
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)
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.
Measured by continuous glucose monitoring
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
Time Frame: HbA1c value at the week 24 and week 48 of extented CL period.
Measured by blood sampling
HbA1c value at the week 24 and week 48 of extented CL period.
Glucose coefficient of variation (CV) and Standard deviation (SD)
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.
Measured by continuous glucose monitoring
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
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.
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
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)
Time Frame: Over twenty-four hour periods on the third and fourth weeks of each treatment period and during 24-week extension period
Mean amplitude of glucose excursions and Low Glucose index as measured by continuous glucose monitoring
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])
Time Frame: During 4 weeks of each treatment period and during 24-week and 48-week extension period

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.
During 4 weeks of each treatment period and during 24-week and 48-week extension period
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 severe hypoglycemia with loss of consciousness
During 4 weeks of each treatment period and during 24-week and 48-week extension period
Number of hospitalizations for severe hypoglycemia or ketoacidosis
Time Frame: During 4 weeks of each treatment period and during 24-week and 48-week extension period
Number of hospitalizations
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
Time Frame: after baseline period (2-week); after crossover period; after 24-week and after 48-week extension period
DTSQ satisfaction questionnaire, with scale from 6 to 0 where 0 is the worth and 6 the best outcome.
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
Time Frame: 24-week and 48-week extension period
Measured by continuous glucose monitoring
24-week and 48-week extension period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pierre Yves BENHAMOU, Pr, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 27, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 22, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-A01365-52

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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