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Covid-19
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open-loop condition | Device | Patient's standard insulin pump setting combined with continuous glucose monitoring sensor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of Serious Adverse Device Effect occuring during the 12-week closed-loop period | 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) | 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) | 12-week period |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
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
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:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvia FRANC, Dr | Sud Francilien Hospital, Corbeil-Essonnes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen University Hospital | Caen | 14033 | France | |||
| Sud Francilien Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41452442 | Derived | 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. |
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| Closed-loop condition | Device | Closed-loop algorithm system paired with continuous glucose monitoring sensor |
|
| 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 |
| 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 | 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 | 36-week period |
| Incidence of severe hyperglycemia: o Number of hospitalizations because of ketoacidosis (i.e. incidence of DKA) | 36-week period |
| Number of technical incidents leading to the interruption of the closed loop | 36-week period |
| Number of serious adverse events, serious adverse device events, unanticipated adverse device effects | 36-week period |
| Area under the curve (AUC) from CGM analysis | 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 | 36-week period |
| Percentage of time spent in the 70-180 mg/dL target range | as recorded by continuous subcutaneous glucose monitoring (CGM) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 36-week period |
| Average fasting glycemia level at 6:00 am | as measured by the Dexcom G6 CGM | 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) | 36-week period |
| Average dose of insulin used & its daily evolution during the entire study duration | 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 | 36-week period |
| Percentage of time spent in closed loop mode (i.e. DBLUS System with loop mode operating) | 36-week period |
| Percentage of time spent in operating mode for the Dexcom G6 CGM | 36-week period |
| Scoring of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) to evaluate the acceptance | 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 | 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 | 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) | 36-week period |
| Questionnaire of usability (for 50 subjects from Arm 1, including 15 adolescents and 35 adults) | after 4 weeks of closed-loop; after 12 weeks of closed-loop |
| Corbeil-Essonnes |
| 91058 |
| France |
| Grenoble University Hospital | Grenoble | 38043 | France |
| Marseille - La Conception University Hospital | Marseille | 13005 | France |
| Necker-Enfants Malades University Hospital | Paris | 75015 | France |
| Reims University Hospital | Reims | 51092 | France |
| Strasbourg University Hospital | Strasbourg | 67000 | France |
| Toulouse - Purpan University Hospital | Toulouse | 31059 | France |
| Toulouse - Rangueil University Hospital | Toulouse | 31059 | France |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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