Diabetes Mellitus, Type 1DBLHUNCT04042207
Diabeloop for Highly Unstable Type 1 Diabetes
A study testing Low Glucose Predictive Suspend system and DBLHU System in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Brittle, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Brittle, Closed-Loop
- What is being tested?
- Low Glucose Predictive Suspend system and DBLHU System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Sep 2019to 22 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Grenoble Alpes University Hospital
Grenoble, 38700
Lille University Hospital
Lille, 59037
About this study
Official title: 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).
- Being tested
- Low Glucose Predictive Suspend system, DBLHU System
- Keywords
- Artificial pancreas, Very Unstable Type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Glucose Predictive Suspend systemDevice
Also called Open-loop condition
consists of sensor-augmented pump therapy (SAP) / Low Glucose Predictive Suspend system (with predictive low glucose management technology)
DBLHU SystemDevice
Also called Closed-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.
| Study group | Role | What they receive |
|---|---|---|
| Reference treatment (Open-Loop) | Active comparator | 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 Receives: Device: Low Glucose Predictive Suspend system; Device: DBLHU System |
| DBLHU system (Closed-Loop) | Experimental | 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 Receives: Device: DBLHU System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days for each treatment period
Secondary outcomes (16)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 24-week and 48-week extension period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start3 Sep 2019
- Primary completion27 Feb 2020
- Study completion22 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- N-of-1 trials consists in a prospectively planned, multiple crossover study in a single individual.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Yves BENHAMOU, Pr, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042207
- Sponsor's protocol ID
- 2019-A01365-52
- Acronym
- DBLHU
- Status last verified
- Oct 2020
- First submitted
- 19 Jul 2019
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04042207
- Acronym / sponsor ID
- DBLHU / 2019-A01365-52
- Keywords
- Artificial pancreas, Very Unstable Type 1 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- N-of-1 trials consists in a prospectively planned, multiple crossover study in a single individual.
| Arm | Type | Receives |
|---|---|---|
| Reference treatment (Open-Loop) | Active comparator | Device: Low Glucose Predictive Suspend system, Device: DBLHU SystemSensor-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 system (Closed-Loop) | Experimental | Device: DBLHU SystemDBLHU 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 |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- with persisting extreme glucose variability despite optimal medical care
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Glucose Predictive Suspend systemAlso: Open-loop conditionconsists of sensor-augmented pump therapy (SAP) / Low Glucose Predictive Suspend system (with predictive low glucose management technology) | Device | Reference treatment (Open-Loop) |
| DBLHU SystemAlso: Closed-loop conditionDBLHU 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. | Device | DBLHU system (Closed-Loop), Reference treatment (Open-Loop) |
Primary outcome
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
16 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
HbA1c levels
Time frame: 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.
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.
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
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
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
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
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
Time frame: 24-week and 48-week extension period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Yves BENHAMOU, Pr principal investigator
University Hospital, Grenoble
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Glucose Predictive Suspend system and DBLHU System in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Brittle, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021; AzTrials last refreshed its copy on 30 Oct 2026.