Diabetes Mellitus, Type 1BETTERNCT05628532
DBLG1 System With TERUMO MEDISAFE WITH Insulin Pump Trial
A study testing Use of the DBLG1 system in people with Diabetes Mellitus, Type 1, run by Diabeloop at 10 sites in France.
Trial summary
This study conducted in 90 adults living with type 1 diabetes is an interventional single-arm open-label before/after multicentric national study conducted as a clinical investigation according to the law EU 2017/745 art. 62. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Use of the DBLG1 system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 10 sitesFrance
- Study dates
- 3 Feb 2023to 29 Apr 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject who is at least 18 years old,
- The total daily dose required must be less than 90 units (U),
- Subject accepting to be treated with 100 U/mL rapid-acting insulin analog,
- Type 1 diabetes treated for at least 6 months (Patients treated by manual injection with insulin pen - MDI - or by competitor open loop systems or former closed loop patients if they stopped the closed loop system > 3 months before inclusion) with a stable insulin therapy regimen for at least 15 days,
- HbA1c ≤ 10%,
- Subject must be affiliated to any kind of social security,
Show all 10Show fewer
- Living in an area covered by a GSM (Global System for Mobile Communications) network,
- Non-isolated patient, not living alone, or having a "resource" person living nearby and having a telephone and the key of his home,
- Must be able to speak and be literate in French,
- Having signed the free and informed consent form
Who cannot join
- Subject receiving a total daily dose of insulin below 8 U,
- Subject suffering from a serious illness or undergoing treatment that might significantly impair diabetes physiology, i.e. glucose-insulin interactions, that might interfere with the medical device (for example irregular treatment by steroids),
- Subject with severe uncorrected hearing impairment and/or severe uncorrected problems of visual acuity,
- Subject unable to understand and perform instructions provided by Diabeloop SA,
- Subject willing to undergo regular MRI, CT or high-frequency electric heat treatment during the study period,
- Subject who is unwilling or unable to maintain contact with the healthcare professional,
Show all 19Show fewer
- Subject using a pacemaker. There is the risk of this device adversely affecting pacemakers and causing them to malfunction,
- Subject is unable to tolerate tape adhesive around the sensor or pump placements,
- Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection),
- Has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks from time of inclusion visit, or plans to take any oral, injectable, or IV steroids during the study,
- Actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks,
- Subject is using DPP-4 inhibitor, GLP-1 agonists, metformin, α-glucosidase inhibitors, thiazolidinediones and/or other SGLT2 inhibitors at time of screening,
- Diagnosed with chronic kidney disease (glomerular filtration < 30 mL/min or Serum creatinine > 176 µmol/L),
- Patient who has had a pancreatectomy or who has pancreatic malfunctions or pancreatic islet transplantation or pancreas transplantation,
- Patient on dialysis,
- Patient with impaired hepatic functions,
- Any other physical or psychological disease, or medication likely to interfere with the conduct of the study and interpretation of the study results as judged by the investigator,
- Pregnant woman or woman of childbearing potential in the absence of an effective method of contraception or if she does not agree to continue using contraception for the duration of the study,
- Patient under legal protection (curatorship)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CH Sud Francilien
Corbeil-Essonnes, 91100
CHU Grenoble
Grenoble, 38043
Groupe Hospitalier La Rochelle - Ré - Aunis
La Rochelle, 17019
CHU Lille - Hôpital Huriez
Lille, 59037
Centre du diabète DIAB-eCARE - HCL
Lyon, 69008
Hôpital la Conception - APHM
Marseille, 13005
Hôpital Nord Laennec
Nantes, 44093
CHU Rennes Pontchaillou
Rennes, 35000
CHRU de Strasbourg - Hôpital Civil
Strasbourg, 67000
CHU Toulouse - Hôpital de Rangueil
Toulouse, 31400
About this study
Official title: Interventional Before/After Study of the Effect of the DBLG1 System With TERUMO MEDISAFE WITH Insulin Pump on Glucose Control of Patients With Type 1 Diabetes in France. The BETTER Trial
This study conducted in 90 adults living with type 1 diabetes is an interventional single-arm open-label before/after multicentric national study conducted as a clinical investigation according to the law EU 2017/745 art. 62.
After a 14-day baseline period during which the patient will use a Dexcom G6 Continuous Glucose Monitoring (CGM) and his current therapy (multiple daily injection or open-loop pump), the patient will start a 42-day treatment period during which he will use the DBLG1 System, a closed loop system (including a DBLG1 handset, a TERUMO MEDISAFE WITH insulin pump, in addition to his Dexcom G6 CGM). An optional 6-week extension period with treatment will be proposed to patients agreeing to pursue the use of the DBLG1 system.
Read more
The main objective is to evaluate the safety and efficacy of the DBLG1 System with a TERUMO MEDISAFE WITH insulin pump in closed-loop for 6 weeks in 90 adults with type 1 diabetes.
Data related to their glycemia, complications, usability and quality of life will be collected.
The study is completed when all patients have their "end of study" file completed in the electronic Case Report Form (eCRF).
Read the detailed description
This study conducted in 90 adults living with type 1 diabetes is an interventional single-arm open-label before/after multicentric national study conducted as a clinical investigation according to the law EU 2017/745 art. 62.
The study periods are as follows:
- 2 weeks of baseline period at home will be performed. During this baseline period, all patients will use their current therapy: MDI or competitor open-loop pump. In addition to their standard treatment, all patients will receive a Dexcom G6 coupled with the DBLG1 handset used exclusively to collect the data
- Followed by a 6 weeks period of time (treatment period): Patients will be equipped with the DBLG1 System including the Medisafe With pump in closed loop mode condition
- And finally a 6 weeks optional extension period will be performed (same conditions as for treatment period)
A comparison will be made first between the 6 weeks of study closed loop and the baseline period and second between the extension closed loop and the baseline period of each patient (each patient will be his / her own control) to evaluate statistical subtlety as a secondary objective of the study. In addition, a comparison of treatment vs extension will also be performed.
Visit 1: Inclusion and start of baseline phase for a duration of 2 weeks The investigator collects the dated and signed consents of patients who meet all inclusion and non-inclusion criteria.
All subjects keep their current treatment (MDI or competitor pumps) and start their baseline phase. All subjects receive a DBLG1 handset coupled with Dexcom G6 to collect data. In each investigation center, subjects are trained by medical staff in accordance with the instructions described in IFU.
Blood HbA1c test is performed in routine between one month before the V1 visit and V1 visit. If there is no routine HbA1c sampling during this period the investigator will prescribe a study specific HbA1c blood test.
Visit 2 : V1 + 2 weeks ± 2 days : End of baseline and start of closed loop period The subject is equipped with the DBLG1 System including Medisafe with pump and trained.
The site team will ensure and confirm the capacity of the subject to daily manage his DBLG1 System and realize the device setting initialization.
The subject is asked to complete Quality of Life questionnaires (HFSII and DDS questionnaires) and DTSQs for satisfaction with his / her current treatment.
The qualified site staff review patient's glycemia control via Yourloops during the first 6 days after the beginning of treatment. An optional visit on V2 + 3 days and / or V2 + 6 days should be organized by site staff in case of any doubts regarding the system's parameters or subject's training. These visits could be performed via a phone call. All supplementary visits and related events are collected via eCRF.
Visit 3: V2 + 6 weeks ± 2 days : End of the closed loop - Start of extension (optional) The patient equipped with the DBLG1 System can continue with the 6 weeks extension phase.
The site team may optimize the device setting if necessary. The subject is asked to complete Quality of Life questionnaires (HFSII and DDS questionnaires) and DTSQs for satisfaction with the DBLG1 System
If they refuse to participate in the extension, the patients leave the study and the material is returned to the investigation site.
Visit 4: V3 + 6 weeks ± 2 days: End of study visit The subject is asked to complete Quality of Life questionnaires (HFSII and DDS questionnaires) and DTSQ for satisfaction with the closed loop DBLG1/Medisafe with Blood HbA1c test is performed
The material is returned to the investigation site
Contact by phone calls or additional visits are allowed during the study. They might be useful to discuss treatments, system parameters and adverse events
The aim of this study is to obtain CE mark for DBLG1 System based on evaluation of safety and efficacy.
The main objective is to evaluate the safety and efficacy of the DBLG1 System in closed-loop for 6 weeks. Analysis will be made between the 6 weeks treatment with closed loop vs the 2 weeks baseline
The secondary objectives of this study are to:
assess the efficacy of DBLG1 System assess the global safety of DBLG1 System assess the compliance with closed loop during treatment / extension phase assess the quality of life and satisfaction and adherence of subjects to the system
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Use of the DBLG1 system
- Keywords
- regulation algorithm, Diabetes Treatment, Closed loop
- 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.
Use of the DBLG1 systemDevice
During the treatment period, the patient will use the DBLG1 system (consisting of a DBLG1 handset with an embedded software named loop mode, a TERUMO MEDISAFE WITH patch pump and a Dexcom continuous glucose monitoring (CGM) G6). The main function of DBLG1 System is to adjust the insulin delivery at the correct time in order to maintain the patient's blood glucose in the target range and thus minimize both hypoglycaemic events and long-term complications associated with elevated average glycemia.
| Study group | Role | What they receive |
|---|---|---|
| Use of the DBLG1 system | Experimental | After a 14-day baseline period during which the patient will use a Dexcom G6 Continuous Glucose Monitoring (CGM) and his current therapy (multiple daily injection or open-loop pump), the patient will start a 42-day treatment period with the DBLG1 system followed by an optional 42-day extension period. Receives: Device: Use of the DBLG1 system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time spent in 70 - 180 mg/dL glycemic range
Impact of the use of DBLG1 system on the time spent in the target 70-180 mg/dL during the main treatment period compared to baseline, in percentage.
Measured: 56 days
Secondary outcomes (17)
Percentage of time spent in specific glycemic ranges
Impact of the use of DBLG1 system on the time spent:
< 54 mg/dL, 54-69 mg/dL, < 70 mg/dL, 70-140 mg/dL, 70-180 mg/dL (for extension period), 181-250 mg/dL, > 250 mg/dL during the main treatment period compared to baseline, and during the extension period compared to baseline, in percentage.
Measured: 98 days
Incidence of severe hypoglycemia
Severe hypoglycemia is defined as hypoglycemia requiring third-party intervention OR with loss of consciousness OR involving hospitalization.
The number of episodes, the number of patients with at least one episode (and percentage) will be described per study period and overall
Measured: 98 days
Incidence of severe hyperglycemia
Severe hyperglycemia is defined as hyperglycemia with occurrence of ketoacidosis above 3 mmol/L OR involving hospitalization. The number of episodes, the number of patients with at least one episode (and percentage) will be described per study period and overall
Measured: 98 days
Number of adverse events, adverse device effects, serious adverse events, serious adverse device effects, unanticipated serious adverse device effects
The number of events, number of patients with at least one event (and percentage) will be described for the following type de AEs:
Adverse Events (AEs) Serious Adverse Events (SAEs) Adverse Device Effects (ADEs) Serious adverse Device Effects (SADEs) Unanticipated Serious adverse Device Effects (USADEs) Description will be provided overall and per study periods.
Measured: 98 days
Evolution of HbA1c measured by blood sampling for patients participating in extension study phase
Impact of the use of DBLG1 system on the evolution of HbA1c measured at baseline and after the extension period.
Measured: 98 days
Glucose management indicator (GMI)
Impact of the use of DBLG1 system on the Glucose management indicator (GMI) during the main treatment period compared to baseline, and during the extension period compared to baseline. The formula used to calculate GMI is: GMI(%) = 3.31 + 0.02392 x [mean glucose in mg/dL].
Measured: 98 days
Average sensor glucose level
Impact of the use of DBLG1 system on mean CGM records during the main treatment period compared to baseline, and during the extension period compared to baseline.
Measured: 98 days
Variability of the glucose level
Impact of the use of DBLG1 system on the variability of the glucose level measured by the glycemic variation coefficient (CV) and Standard Deviation (SD) intra patient during the main treatment period compared to baseline, and during the extension period compared to baseline.
Measured: 98 days
Average dose of insulin used during the entire study
The average sensor glucose level is calculated per patient as the average of all its CGM records over a study period.
Measured: 98 days
Percentage of time spent in closed loop mode
For both study and extension closed loop period, the percentage of time spent with close loop mode on will be calculated as the number of CGM records under close loop over the number of possible CGM records during the period. This endpoint will be described overall and per period concerned.
Measured: 98 days
Percentage of days with >75% closed loop records
For both study and extension closed loop period, the percentage of days with >75% closed loop records will be described as a quantitative parameter.
Measured: 98 days
Diabetes Treatment Satisfaction (DTSQs) Questionnaire items
The 8 DTSQ questionnaire items will be described as qualitative and quantitative outcomes at baseline, treatment and extension period. The minimum and maximum scores per item are 0 and 6, respectively. The higher the score, the more satisfied the patient is with the treatment.
The evolution in score will be compared.
Measured: 98 days
Scoring of Diabetes Treatment Satisfaction (DTSQs) Questionnaire
The DTSQ score is the sum of the 8 questionnaire items. It has a minimum of zero and a maximum of 36. The higher the score, the more satisfied the patient is with the treatment.
DTSQ score will be described as continuous parameters at baseline, treatment and extension period.
The evolution in score will be compared.
Measured: 98 days
Scoring of Hypoglycemia Fear Survey (HFS II) questionnaire total score
The Hypoglycemia Fear Survey (HFS) II questionnaire consists of 33 items. The HFS II score has a minimum of 0 and a maximum of 132. The higher the score, the more the patient fears hypoglycemia. The total score will be described as continuous parameters at baseline and at end of study. The evolution in score will be compared.
Measured: 98 days
Scoring of Hypoglycemia Fear Survey (HFS II) questionnaire - Behaviour scale
The 15 items in Hypoglycemia Fear Survey (HFS-B) Behavior scale measure behaviors aimed at avoiding hypoglycemia and its possible negative consequences. The HFS-B score will be described as continuous parameters at baseline and at end of study. The evolution in score will be compared. The score has a minimum of 0 and a maximum of 60. The higher the score, the more the patient fears hypoglycemia.
Measured: 98 days
Scoring of Hypoglycemia Fear Survey (HFS II) questionnaire - Worrieness scale
The 18 items in Hypoglycemia Fear Survey (HFS-W) Worriedness scale measure various aspects relating to hypoglycemic episodes that provoke anxiety. The HFS-W score will be described as continuous parameters at baseline and at end of study. The evolution in score will be compared.
The score has a minimum of 0 and a maximum of 72. The higher the score, the more the patient fears hypoglycemia.
Measured: 98 days
Scoring of Diabetes Distress Scale (DDS)
The 17 items of DDS will be described both as continuous and categorical variables at baseline, treatment and extension period. Each item is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant problem". Average scores will be computed and described for the four critical dimensions of distress: emotional burden, regimen distress, interpersonal distress and physician distress. The minimum and maximum scores will be 1 and 6, respectively.
The evolution in DDS average score will be compared.
Measured: 98 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start3 Feb 2023
- Primary completion21 Feb 2024
- Study completion29 Apr 2024
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional single-arm open-label before/after multicentric national study
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabeloop
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Icadom
- Responsible party
- Sponsor
- Investigators
- Alfred PENFORNIS, Pr, Principal investigator, CH Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628532
- Sponsor's protocol ID
- RCB 2022-A01901-42
- Acronym
- BETTER
- Status last verified
- May 2024
- First submitted
- 16 Nov 2022
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Before/After Study of the Effect of the DBLG1 System With TERUMO MEDISAFE WITH Insulin Pump on Glucose Control of Patients With Type 1 Diabetes in France. The BETTER Trial
- ClinicalTrials.gov ID
- NCT05628532
- Acronym / sponsor ID
- BETTER / RCB 2022-A01901-42
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- regulation algorithm, Diabetes Treatment, Closed loop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- DiabeloopIndustry (pharma, biotech, devices)
- Collaborators
- Icadom
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 28 Nov 2022 (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.
This study conducted in 90 adults living with type 1 diabetes is an interventional single-arm open-label before/after multicentric national study conducted as a clinical investigation according to the law EU 2017/745 art. 62.
After a 14-day baseline period during which the patient will use a Dexcom G6 Continuous Glucose Monitoring (CGM) and his current therapy (multiple daily injection or open-loop pump), the patient will start a 42-day treatment period during which he will use the DBLG1 System, a closed loop system (including a DBLG1 handset, a TERUMO MEDISAFE WITH insulin pump, in addition to his Dexcom G6 CGM). An optional 6-week extension period with treatment will be proposed to patients agreeing to pursue the use of the DBLG1 system.
The main objective is to evaluate the safety and efficacy of the DBLG1 System with a TERUMO MEDISAFE WITH insulin pump in closed-loop for 6 weeks in 90 adults with type 1 diabetes.
Data related to their glycemia, complications, usability and quality of life will be collected.
The study is completed when all patients have their "end of study" file completed in the electronic Case Report Form (eCRF).
Detailed description
This study conducted in 90 adults living with type 1 diabetes is an interventional single-arm open-label before/after multicentric national study conducted as a clinical investigation according to the law EU 2017/745 art. 62.
The study periods are as follows:
- 2 weeks of baseline period at home will be performed. During this baseline period, all patients will use their current therapy: MDI or competitor open-loop pump. In addition to their standard treatment, all patients will receive a Dexcom G6 coupled with the DBLG1 handset used exclusively to collect the data
- Followed by a 6 weeks period of time (treatment period): Patients will be equipped with the DBLG1 System including the Medisafe With pump in closed loop mode condition
- And finally a 6 weeks optional extension period will be performed (same conditions as for treatment period)
A comparison will be made first between the 6 weeks of study closed loop and the baseline period and second between the extension closed loop and the baseline period of each patient (each patient will be his / her own control) to evaluate statistical subtlety as a secondary objective of the study. In addition, a comparison of treatment vs extension will also be performed.
Visit 1: Inclusion and start of baseline phase for a duration of 2 weeks The investigator collects the dated and signed consents of patients who meet all inclusion and non-inclusion criteria.
All subjects keep their current treatment (MDI or competitor pumps) and start their baseline phase. All subjects receive a DBLG1 handset coupled with Dexcom G6 to collect data. In each investigation center, subjects are trained by medical staff in accordance with the instructions described in IFU.
Blood HbA1c test is performed in routine between one month before the V1 visit and V1 visit. If there is no routine HbA1c sampling during this period the investigator will prescribe a study specific HbA1c blood test.
Visit 2 : V1 + 2 weeks ± 2 days : End of baseline and start of closed loop period The subject is equipped with the DBLG1 System including Medisafe with pump and trained.
The site team will ensure and confirm the capacity of the subject to daily manage his DBLG1 System and realize the device setting initialization.
The subject is asked to complete Quality of Life questionnaires (HFSII and DDS questionnaires) and DTSQs for satisfaction with his / her current treatment.
The qualified site staff review patient's glycemia control via Yourloops during the first 6 days after the beginning of treatment. An optional visit on V2 + 3 days and / or V2 + 6 days should be organized by site staff in case of any doubts regarding the system's parameters or subject's training. These visits could be performed via a phone call. All supplementary visits and related events are collected via eCRF.
Visit 3: V2 + 6 weeks ± 2 days : End of the closed loop - Start of extension (optional) The patient equipped with the DBLG1 System can continue with the 6 weeks extension phase.
The site team may optimize the device setting if necessary. The subject is asked to complete Quality of Life questionnaires (HFSII and DDS questionnaires) and DTSQs for satisfaction with the DBLG1 System
If they refuse to participate in the extension, the patients leave the study and the material is returned to the investigation site.
Visit 4: V3 + 6 weeks ± 2 days: End of study visit The subject is asked to complete Quality of Life questionnaires (HFSII and DDS questionnaires) and DTSQ for satisfaction with the closed loop DBLG1/Medisafe with Blood HbA1c test is performed
The material is returned to the investigation site
Contact by phone calls or additional visits are allowed during the study. They might be useful to discuss treatments, system parameters and adverse events
The aim of this study is to obtain CE mark for DBLG1 System based on evaluation of safety and efficacy.
The main objective is to evaluate the safety and efficacy of the DBLG1 System in closed-loop for 6 weeks. Analysis will be made between the 6 weeks treatment with closed loop vs the 2 weeks baseline
The secondary objectives of this study are to:
assess the efficacy of DBLG1 System assess the global safety of DBLG1 System assess the compliance with closed loop during treatment / extension phase assess the quality of life and satisfaction and adherence of subjects to the system
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional single-arm open-label before/after multicentric national study
| Arm | Type | Receives |
|---|---|---|
| Use of the DBLG1 system | Experimental | Device: Use of the DBLG1 systemAfter a 14-day baseline period during which the patient will use a Dexcom G6 Continuous Glucose Monitoring (CGM) and his current therapy (multiple daily injection or open-loop pump), the patient will start a 42-day treatment period with the DBLG1 system followed by an optional 42-day extension period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject who is at least 18 years old,
- The total daily dose required must be less than 90 units (U),
- Subject accepting to be treated with 100 U/mL rapid-acting insulin analog,
- Type 1 diabetes treated for at least 6 months (Patients treated by manual injection with insulin pen - MDI - or by competitor open loop systems or former closed loop patients if they stopped the closed loop system > 3 months before inclusion) with a stable insulin therapy regimen for at least 15 days,
- HbA1c ≤ 10%,
Key exclusion criteria (19 listed)
- Subject receiving a total daily dose of insulin below 8 U,
- Subject suffering from a serious illness or undergoing treatment that might significantly impair diabetes physiology, i.e. glucose-insulin interactions, that might interfere with the medical device (for example irregular treatment by steroids),
- Subject with severe uncorrected hearing impairment and/or severe uncorrected problems of visual acuity,
- Subject unable to understand and perform instructions provided by Diabeloop SA,
- Subject willing to undergo regular MRI, CT or high-frequency electric heat treatment during the study period,
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 |
|---|---|---|
| Use of the DBLG1 systemDuring the treatment period, the patient will use the DBLG1 system (consisting of a DBLG1 handset with an embedded software named loop mode, a TERUMO MEDISAFE WITH patch pump and a Dexcom continuous glucose monitoring (CGM) G6). The main function of DBLG1 System is to adjust the insulin delivery at the correct time in order to maintain the patient's blood glucose in the target range and thus minimize both hypoglycaemic events and long-term complications associated with elevated average glycemia. | Device | Use of the DBLG1 system |
Primary outcome
Percentage of time spent in 70 - 180 mg/dL glycemic range
Time frame: 56 days
Impact of the use of DBLG1 system on the time spent in the target 70-180 mg/dL during the main treatment period compared to baseline, in percentage.
17 secondary outcomes
Percentage of time spent in specific glycemic ranges
Time frame: 98 days
Incidence of severe hypoglycemia
Time frame: 98 days
Incidence of severe hyperglycemia
Time frame: 98 days
Number of adverse events, adverse device effects, serious adverse events, serious adverse device effects, unanticipated serious adverse device effects
Time frame: 98 days
Evolution of HbA1c measured by blood sampling for patients participating in extension study phase
Time frame: 98 days
Glucose management indicator (GMI)
Time frame: 98 days
Average sensor glucose level
Time frame: 98 days
Variability of the glucose level
Time frame: 98 days
Average dose of insulin used during the entire study
Time frame: 98 days
Percentage of time spent in closed loop mode
Time frame: 98 days
Percentage of days with >75% closed loop records
Time frame: 98 days
Diabetes Treatment Satisfaction (DTSQs) Questionnaire items
Time frame: 98 days
Scoring of Diabetes Treatment Satisfaction (DTSQs) Questionnaire
Time frame: 98 days
Scoring of Hypoglycemia Fear Survey (HFS II) questionnaire total score
Time frame: 98 days
Scoring of Hypoglycemia Fear Survey (HFS II) questionnaire - Behaviour scale
Time frame: 98 days
Scoring of Hypoglycemia Fear Survey (HFS II) questionnaire - Worrieness scale
Time frame: 98 days
Scoring of Diabetes Distress Scale (DDS)
Time frame: 98 days
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 7 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Alfred PENFORNIS, Pr principal investigator
CH Sud Francilien
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of the DBLG1 system in people with Diabetes Mellitus, Type 1, run by Diabeloop at 10 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 10 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 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 time spent in 70 - 180 mg/dL glycemic range (time frame: 56 days). 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 7 May 2024.