Diabetes Mellitus, Type 1DIABELOOP SP8NCT04190277
Safety Assessment of DBLUS System in Adolescent and Adult Patients With Type 1 Diabetes and Assessment of Its Clinical Efficacy (DIABELOOP SP8)
A study testing Open-loop condition and Closed-loop condition in people with Diabetes Mellitus, Type 1 and Closed-Loop, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 9 sites in France.
Trial summary
This clinical trial is a randomized trial including a 3-month single-arm part and a 6-month extension phase. Following randomization between the 1st group and 2nd group, a 2-week baseline period in open-loop for 148 adults and 30 adolescents will be performed. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Closed-Loop
- What is being tested?
- Open-loop condition and Closed-loop condition
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 9 sitesFrance
- Study dates
- 7 Jan 2020to 16 Jun 2020
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age 14 - 75 years at time of screening
- Type 1 diabetes
- Subject has a clinical diagnosis of type 1 diabetes for at least 2 years as determined via medical records or source documentation by an individual qualified to make a medical diagnosis.
- An insulin pump user for at least 6 months (with or without CGM experience),
- Living in an area covered by a GSM (Global System for Mobile Communications) network
- Patient not isolated, does not live alone, or has a person living nearby who has a telephone and a key to his or her home
Show all 20Show fewer
- Patient willing to wear the system continuously throughout the study
- Has TSH in the normal range
- if subject has celiac disease, it has been adequately treated as determined by the investigator
- With history of cardiovascular event 1 year or more from the time of screening must have an EKG within 6 months prior to screening and a stress test within 6 months prior to screening or during screening. If subject has an abnormal stress test, he will not be allowed to participate in the study, unless there is clearance from a cardiologist. If subject fails stress test, participation is allowed only if there is clearance from a cardiologist
- With 3 or more cardiovascular risk factors listed below must have an EKG within 6 months prior to screening or during screening. If subject has an abnormal EKG, participation is allowed if there is clearance from a cardiologist. Cardiovascular risk factors include:
- Age >35 years
- Type 1 diabetes of >15 years' duration
- Presence of any additional risk factor for coronary artery disease
- Presence of microvascular disease (proliferative retinopathy or nephropathy, including microalbuminuria)
- Presence of peripheral vascular disease
- Presence of autonomic neuropathy
- Must be able to speak and be literate in French
- For adults (18 - 75 years old): having provided written informed consent
- For adolescents (14 - 17 years old): having provided written assent \& parents/guardian having provided written informed consent
Who cannot join
- Patient receiving a total daily dose of insulin lower than 8 U
- Patient with a daily dose of insulin required greater than 90 units
- Patient having severe problems of uncorrected hearing and/or visual acuity
- Patient unable to understand and perform all of the instructions provided by Diabeloop SA
- 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)
Show all 30Show fewer
- Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
- Is being treated for hyperthyroidism at time of screening
- Has diagnosis of adrenal insufficiency
- Has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the study
- Females who are sexually active and able to conceive will be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study as determined by investigator.
- 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
- Currently abusing illicit drugs
- Currently abusing marijuana
- Currently abusing prescription drugs
- Currently abusing alcohol
- Subject is using pramlintide (Symlin), DDP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening
- Subject has elective surgery planned that requires general anesthesia during the study
- Has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
- Plans to receive red blood cell transfusion or erythropoietin over study participation
- Diagnosed with current eating disorder such as anorexia or bulimia
- Diagnosed with chronic kidney disease that results in chronic anemia
- Hematocrit that is below the normal reference range of lab used
- Patient who has had a pancreatectomy or who has pancreatic malfunctions
- Patient with pancreatic islet transplantation or pancreas transplantation
- Patient on dialysis
- Patient with impaired hepatic functions
- Serum creatinine > 176 µmol/L
- 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.
- Pregnancy
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Caen University Hospital
Caen, 14033
Sud Francilien Hospital
Corbeil-Essonnes, 91058
Grenoble University Hospital
Grenoble, 38043
Marseille - La Conception University Hospital
Marseille, 13005
Necker-Enfants Malades University Hospital
Paris, 75015
Reims University Hospital
Reims, 51092
Strasbourg University Hospital
Strasbourg, 67000
Toulouse - Purpan University Hospital
Toulouse, 31059
Toulouse - Rangueil University Hospital
Toulouse, 31059
About this study
Official title: Safety Assessment of DBLUS System in Adolescent and Adult Patients With Type 1 Diabetes and Assessment of Its Clinical Efficacy in a Randomized Trial for 3 Months Followed by an Extension Period
This clinical trial is a randomized trial including a 3-month single-arm part and a 6-month extension phase.
- Following randomization between the 1st group and 2nd group, a 2-week baseline period in open-loop for 148 adults and 30 adolescents will be performed. Patients will receive the standard of care treatment including their usual subcutaneous insulin pump augmented with continuous glucose measurement with Dexcom G6.
- Then, a 3-month study phase will be performed during 12 weeks:
- 1st group (111 adults randomized from 148 adults and 30 adolescents) will receive the treatment via the Closed-loop System (closed-loop condition).
- 2nd group (37 adult controls randomized from 148 adults) will receive the standard of care treatment including their usual subcutaneous insulin pump augmented with continuous glucose measurement with Dexcom G6 (open loop condition).
- An extension period of 6 months with the Closed-loop System (closed-loop condition) will be performed at the end of the study phase for all patients enrolled.
- Conditions
- Diabetes Mellitus, Type 1, Closed-Loop
- Being tested
- Open-loop condition, Closed-loop condition
- Keywords
- Artificial Pancreas, Adolescents, Adults
- 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.
Open-loop conditionDevice
Patient's standard insulin pump setting combined with continuous glucose monitoring sensor
Closed-loop conditionDevice
Closed-loop algorithm system paired with continuous glucose monitoring sensor
| Study group | Role | What they receive |
|---|---|---|
| 36-week Closed-Loop | Experimental | 2-week baseline period in open-loop condition, then 12-week period in closed-loop condition followed by a 24-week extension period in closed-loop condition Receives: Device: Open-loop condition; Device: Closed-loop condition |
| 12-week open-loop and 24-week closed-loop | Active comparator | 2-week baseline period in open-loop condition, then 12-week period in open-loop condition followed by a 24-week extension period in closed-loop condition Receives: Device: Open-loop condition; Device: Closed-loop condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of Serious Adverse Device Effect occuring during the 12-week closed-loop period
Measured: 12-weeks closed-loop period
Percentage of time spent in hypoglycemia (glucose level below 70mg/dL (3.9 mmol/L)) between baseline period (2-week period) and in-home study phase in closed-loop (12-week period) for the whole patients of the "single-arm" part
as recorded by continuous subcutaneous glucose monitoring (CGM)
Measured: 14-week baseline & closed-loop period
Difference in percentage of time spent in hypoglycemia (<70mg/dL) during 12 weeks between closed-loop and open-loop
as recorded by continuous subcutaneous glucose monitoring (CGM)
Measured: 12-week period
Secondary outcomes (28)
Percentage of sensor time in glucose level o < 50mg/dL (2.8 mmol/L) o < 60 mg/dL (3.3 mmol/L) o < 70mg/dL (3.9 mmol/L)
measured by the Dexcom G6 CGM
Measured: during nights, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am throughout the 38-week study
Number of hypoglycemic episodes with beginning and end of episode o < 70 mg/dL (3.9 mmol/L) o ≤ 54 mg/dL (3 mmol/L)
as measured by the Dexcom G6 CGM
Measured: 36-week period
Incidence of severe hypoglycemia: o Number of severe hypoglycemic episodes needing a third-party intervention o Number of severe hypoglycemic episodes with loss of consciousness o Number of hospitalizations because of a severe hypoglycemia episode
Measured: 36-week period
Number of severe hyperglycemia episodes with beginning and end of episode : o > 350 mg/dL (19.4 mmol/L) o > 360 mg/dL (20 mmol/L) or significant ketosis (plasmatic ketones > 3 mmol/L) as defined by the ADA.
as measured by the Dexcom G6 CGM
Measured: 36-week period
Incidence of severe hyperglycemia: o Number of hospitalizations because of ketoacidosis (i.e. incidence of DKA)
Measured: 36-week period
Number of technical incidents leading to the interruption of the closed loop
Measured: 36-week period
Number of serious adverse events, serious adverse device events, unanticipated adverse device effects
Measured: 36-week period
Area under the curve (AUC) from CGM analysis
Measured: 36-week period
Risk of hypoglycemia and hyperglycemia (LBGI/HBGI)
Low Blood Glucose Interstitial \& High Blood Glucose Interstitial as measured by the Dexcom G6 CGM
Measured: 36-week period
Percentage of time spent in the 70-180 mg/dL target range
as recorded by continuous subcutaneous glucose monitoring (CGM)
Measured: during 12 weeks during nights, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am throughout the 38-week study
Percentage of time spent in the 70-180 mg/dL target range
as recorded by continuous subcutaneous glucose monitoring (CGM)
Measured: during nights, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am throughout the 38-week study
Percentage of sensor time in glucose level : o < 50 mg/dL (2.8 mmol/L), o < 54 mg/dL (3.0 mmol/L) o < 60 mg/dL (3.3 mmol/L), o < 70 mg/dL (3.9 mmol/L)
as recorded by continuous subcutaneous glucose monitoring (CGM)
Measured: during nights, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am throughout the 38-week study
Percentage of sensor time in glucose range 54-70 mg/dL (3.0 - 3.9 mmol/L)
as recorded by continuous subcutaneous glucose monitoring (CGM)
Measured: during nights, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am throughout the 38-week study
Percentage of sensor time in glucose range 70-140 mg/dL (3.9 - 7.8 mmol/L)
as recorded by continuous subcutaneous glucose monitoring (CGM)
Measured: during nights, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am throughout the 38-week study
Percentage of sensor time in glucose level o > 180 mg/dL (10.0 mmol/L), o > 250 mg/dL (13.9 mmol/L), o > 300 mg/dL (16.7 mmol/L) o > 350 mg/dL (19.4 mmol/L)
as recorded by continuous subcutaneous glucose monitoring (CGM)
Measured: during nights, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am throughout the 38-week study
Evolution of glycosylated hemoglobin between inclusion and end of study
calculated from CGM data and measured by blood sampling
Measured: at inclusion, after 12-week period, after 24-week extension period
Average glycemia level during the entire period
as measured by the Dexcom G6 CGM
Measured: 36-week period
Average fasting glycemia level at 6:00 am
as measured by the Dexcom G6 CGM
Measured: 36-week period
Variability of the glycemia level measured by o the glycemic variation coefficient (CV) intra patient: • CV < 36% • CV ≥ 36% o Standard deviation (SD)
Measured: 36-week period
Average dose of insulin used & its daily evolution during the entire study duration
Measured: 36-week period
Evolution over time of the DBLUS system's performance on a day-to-day and determination of the optimization delay of glycemic control
Measured: 36-week period
Percentage of time spent in closed loop mode (i.e. DBLUS System with loop mode operating)
Measured: 36-week period
Percentage of time spent in operating mode for the Dexcom G6 CGM
Measured: 36-week period
Scoring of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) to evaluate the acceptance
Measured: after baseline period (2-week); after12-week-period; after 24-week extension period
Scoring of the Diabetes Quality of Life (DQOL) questionnaire to evaluate the acceptance
Measured: after baseline period (2-week); after12-week-period; after 24-week extension period
Scoring of the Hypoglycemia Fear Survey (HFS) questionnaire to evaluate the acceptance
Measured: after baseline period (2-week); after12-week-period; after 24-week extension period
Evolution of the weekly average number of CHO intake (for patient with closed-loop)
Measured: 36-week period
Questionnaire of usability (for 50 subjects from Arm 1, including 15 adolescents and 35 adults)
Measured: after 4 weeks of closed-loop; after 12 weeks of closed-loop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start7 Jan 2020
- Primary completion16 Mar 2020
- Study completion16 Jun 2020
Why it stopped: Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 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
- Sylvia FRANC, Dr, Principal investigator, Sud Francilien Hospital, Corbeil-Essonnes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190277
- Sponsor's protocol ID
- 2019-A01975-52
- Acronym
- DIABELOOP SP8
- Status last verified
- Apr 2021
- First submitted
- 19 Nov 2019
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Franc S, Reznik Y, Amadou C, Penfornis A, Schaepelynck P, Hanaire H, Delemer B, Le Tallec C, Beltrand J, Jeandidier N, Bensaid S, Orlando L, Hannaert P, Benhamou PY, Charpentier G. Safety and glycemic outcomes of DBLG1 coupled to the DANA-i pump in adults and adolescents with type 1 diabetes mellitus. The SP8 trial. J Endocrinol Invest. 2026 Apr;49(4):959-968. doi: 10.1007/s40618-025-02780-5. Epub 2025 Dec 26.
PubMed 41452442
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Assessment of DBLUS System in Adolescent and Adult Patients With Type 1 Diabetes and Assessment of Its Clinical Efficacy in a Randomized Trial for 3 Months Followed by an Extension Period
- ClinicalTrials.gov ID
- NCT04190277
- Acronym / sponsor ID
- DIABELOOP SP8 / 2019-A01975-52
- Conditions
- Diabetes Mellitus, Type 1, Closed-Loop
- Keywords
- Artificial Pancreas, Adolescents, Adults
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid-19
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Jun 2020 (actual)
- First posted
- 9 Dec 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.
This clinical trial is a randomized trial including a 3-month single-arm part and a 6-month extension phase.
- Following randomization between the 1st group and 2nd group, a 2-week baseline period in open-loop for 148 adults and 30 adolescents will be performed. Patients will receive the standard of care treatment including their usual subcutaneous insulin pump augmented with continuous glucose measurement with Dexcom G6.
- Then, a 3-month study phase will be performed during 12 weeks:
- 1st group (111 adults randomized from 148 adults and 30 adolescents) will receive the treatment via the Closed-loop System (closed-loop condition).
- 2nd group (37 adult controls randomized from 148 adults) will receive the standard of care treatment including their usual subcutaneous insulin pump augmented with continuous glucose measurement with Dexcom G6 (open loop condition).
- An extension period of 6 months with the Closed-loop System (closed-loop condition) will be performed at the end of the study phase for all patients enrolled.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 36-week Closed-Loop | Experimental | Device: Open-loop condition, Device: Closed-loop condition2-week baseline period in open-loop condition, then 12-week period in closed-loop condition followed by a 24-week extension period in closed-loop condition |
| 12-week open-loop and 24-week closed-loop | Active comparator | Device: Open-loop condition, Device: Closed-loop condition2-week baseline period in open-loop condition, then 12-week period in open-loop condition followed by a 24-week extension period in closed-loop condition |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- age 14 - 75 years at time of screening
- Type 1 diabetes
- Subject has a clinical diagnosis of type 1 diabetes for at least 2 years as determined via medical records or source documentation by an individual qualified to make a medical diagnosis.
- An insulin pump user for at least 6 months (with or without CGM experience),
- Living in an area covered by a GSM (Global System for Mobile Communications) network
Key exclusion criteria (30 listed)
- Patient receiving a total daily dose of insulin lower than 8 U
- Patient with a daily dose of insulin required greater than 90 units
- Patient having severe problems of uncorrected hearing and/or visual acuity
- Patient unable to understand and perform all of the instructions provided by Diabeloop SA
- Subject is unable to tolerate tape adhesive around the sensor or pump placements
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 |
|---|---|---|
| Open-loop conditionPatient's standard insulin pump setting combined with continuous glucose monitoring sensor | Device | 12-week open-loop and 24-week closed-loop, 36-week Closed-Loop |
| Closed-loop conditionClosed-loop algorithm system paired with continuous glucose monitoring sensor | Device | 12-week open-loop and 24-week closed-loop, 36-week Closed-Loop |
Primary outcome
Incidence rate of Serious Adverse Device Effect occuring during the 12-week closed-loop period
Time frame: 12-weeks closed-loop period
Percentage of time spent in hypoglycemia (glucose level below 70mg/dL (3.9 mmol/L)) between baseline period (2-week period) and in-home study phase in closed-loop (12-week period) for the whole patients of the "single-arm" part
Time frame: 14-week baseline & closed-loop period
as recorded by continuous subcutaneous glucose monitoring (CGM)
Difference in percentage of time spent in hypoglycemia (<70mg/dL) during 12 weeks between closed-loop and open-loop
Time frame: 12-week period
as recorded by continuous subcutaneous glucose monitoring (CGM)
28 secondary outcomes
Percentage of sensor time in glucose level o < 50mg/dL (2.8 mmol/L) o < 60 mg/dL (3.3 mmol/L) o < 70mg/dL (3.9 mmol/L)
Time frame: during nights, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am throughout the 38-week study
Number of hypoglycemic episodes with beginning and end of episode o < 70 mg/dL (3.9 mmol/L) o ≤ 54 mg/dL (3 mmol/L)
Time frame: 36-week period
Incidence of severe hypoglycemia: o Number of severe hypoglycemic episodes needing a third-party intervention o Number of severe hypoglycemic episodes with loss of consciousness o Number of hospitalizations because of a severe hypoglycemia episode
Time frame: 36-week period
Number of severe hyperglycemia episodes with beginning and end of episode : o > 350 mg/dL (19.4 mmol/L) o > 360 mg/dL (20 mmol/L) or significant ketosis (plasmatic ketones > 3 mmol/L) as defined by the ADA.
Time frame: 36-week period
Incidence of severe hyperglycemia: o Number of hospitalizations because of ketoacidosis (i.e. incidence of DKA)
Time frame: 36-week period
Number of technical incidents leading to the interruption of the closed loop
Time frame: 36-week period
Number of serious adverse events, serious adverse device events, unanticipated adverse device effects
Time frame: 36-week period
Area under the curve (AUC) from CGM analysis
Time frame: 36-week period
Risk of hypoglycemia and hyperglycemia (LBGI/HBGI)
Time frame: 36-week period
Percentage of time spent in the 70-180 mg/dL target range
Time frame: during 12 weeks during nights, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am throughout the 38-week study
Percentage of time spent in the 70-180 mg/dL target range
Time frame: during nights, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am throughout the 38-week study
Percentage of sensor time in glucose level : o < 50 mg/dL (2.8 mmol/L), o < 54 mg/dL (3.0 mmol/L) o < 60 mg/dL (3.3 mmol/L), o < 70 mg/dL (3.9 mmol/L)
Time frame: during nights, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am throughout the 38-week study
Percentage of sensor time in glucose range 54-70 mg/dL (3.0 - 3.9 mmol/L)
Time frame: during nights, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am throughout the 38-week study
Percentage of sensor time in glucose range 70-140 mg/dL (3.9 - 7.8 mmol/L)
Time frame: during nights, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am throughout the 38-week study
Percentage of sensor time in glucose level o > 180 mg/dL (10.0 mmol/L), o > 250 mg/dL (13.9 mmol/L), o > 300 mg/dL (16.7 mmol/L) o > 350 mg/dL (19.4 mmol/L)
Time frame: during nights, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am throughout the 38-week study
Evolution of glycosylated hemoglobin between inclusion and end of study
Time frame: at inclusion, after 12-week period, after 24-week extension period
Average glycemia level during the entire period
Time frame: 36-week period
Average fasting glycemia level at 6:00 am
Time frame: 36-week period
Variability of the glycemia level measured by o the glycemic variation coefficient (CV) intra patient: • CV < 36% • CV ≥ 36% o Standard deviation (SD)
Time frame: 36-week period
Average dose of insulin used & its daily evolution during the entire study duration
Time frame: 36-week period
Evolution over time of the DBLUS system's performance on a day-to-day and determination of the optimization delay of glycemic control
Time frame: 36-week period
Percentage of time spent in closed loop mode (i.e. DBLUS System with loop mode operating)
Time frame: 36-week period
Percentage of time spent in operating mode for the Dexcom G6 CGM
Time frame: 36-week period
Scoring of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) to evaluate the acceptance
Time frame: after baseline period (2-week); after12-week-period; after 24-week extension period
Scoring of the Diabetes Quality of Life (DQOL) questionnaire to evaluate the acceptance
Time frame: after baseline period (2-week); after12-week-period; after 24-week extension period
Scoring of the Hypoglycemia Fear Survey (HFS) questionnaire to evaluate the acceptance
Time frame: after baseline period (2-week); after12-week-period; after 24-week extension period
Evolution of the weekly average number of CHO intake (for patient with closed-loop)
Time frame: 36-week period
Questionnaire of usability (for 50 subjects from Arm 1, including 15 adolescents and 35 adults)
Time frame: after 4 weeks of closed-loop; after 12 weeks of closed-loop
Results and safety
The study was stopped early (reason given: Covid-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Derived from this study: PubMed 41452442Franc S, Reznik Y, Amadou C, Penfornis A, Schaepelynck P, Hanaire H, Delemer B, Le Tallec C, Beltrand J, Jeandidier N, Bensaid S, Orlando L, Hannaert P, Benhamou PY, Charpentier G. Safety and glycemic outcomes of DBLG1 coupled to the DANA-i pump in adults and adolescents with type 1 diabetes mellitus. The SP8 trial. J Endocrinol Invest. 2026 Apr;49(4):959-968. doi: 10.1007/s40618-025-02780-5. Epub 2025 Dec 26.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 1
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Sylvia FRANC, Dr principal investigator
Sud Francilien Hospital, Corbeil-Essonnes
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open-loop condition and Closed-loop condition in people with Diabetes Mellitus, Type 1 and Closed-Loop, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 9 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 20 inclusion and 30 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: stopped early, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 was stopped early (reason given: Covid-19). Results are not available in the source record.
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?
Incidence rate of Serious Adverse Device Effect occuring during the 12-week closed-loop period (time frame: 12-weeks closed-loop period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04190277, which also lists 1 linked publication.
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 8 Apr 2021.