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The purpose of the study is to evaluate the efficacy in glycemic control and the impact on the quality of life of patients using the MiniMed™ 780G System for the treatment of Type 1 diabetes, in real life settings in France.
Local, post-market, non-interventional, prospective, single-arm, multi-center study of patients pediatric and adult.
The study is conducted according to the same schedule as the routine follow-up of patients:
Approximately 300 patients (children and adults) will be enrollment in the study in approximately 32 sites in France.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MiniMed™ 780G System | Subject will use the MiniMed™ 780G System as per standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiniMed™ 780G System | Device | Subject enrolled in the study will start using the MiniMed™ 780G pump in Auto Mode after a run-in period of two weeks in Manual Mode (with no SmartGuard™ functions). Study phase in Automode will follow a 6 and 12 months follow- up as per standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Range 70-180 mg/dL (TIR) | The change in (%) the time spent within range, defined as the proportion of sensor glucose concentration within the target range of 70-180 mg/dL, between baseline and 6 months. | 0-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction Score | To evaluate the change from baseline in satisfaction score based on the Diabetes Treatment Satisfaction Questionnaire change (DTSQc) | 0-6 months |
| Quality of Life Change | To evaluate the change in quality of life based on the Diabetes Quality of life questionnaire (DQoL) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects 7 years of age or older with T1D and under Continuous Subcutaneous Insulin Infusion (CSII) therapy (with or without CGM)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | France | ||||
| CHU Besançon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39688775 | Derived | Kessler L, Thivolet C, Penfornis A, Gouet D, Coffin C, Moret M, Borot S, Bekka S, Sonnet E, Joubert M, Lablanche S, Burtin G, Di Piazza F, van den Heuvel T, Cohen O. Advanced Hybrid Closed Loop Algorithm Use in Type 1 Diabetes: The French MiniMed Glycemic Control and Quality of Life Study. Diabetes Ther. 2025 Mar;16(3):413-427. doi: 10.1007/s13300-024-01673-9. Epub 2024 Dec 17. |
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306 subjects with type 1 diabetes consented to participate in the study. Of them, 16 subjects are Screen Failure.
Date of first subject enrollment: 15-FEB-2021, Date of last data received: 23-NOV-2022
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| ID | Title | Description |
|---|---|---|
| FG000 | MiniMed™ 780G System | Subject will use the MiniMed™ 780G System as per standard of care. MiniMed™ 780G System: Subject enrolled in the study will start using the MiniMed™ 780G pump in Auto Mode after a run-in period of two weeks in Manual Mode (with no SmartGuard™ functions). Study phase in Automode will follow a 6 and 12 months follow- up as per standard of care. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Run-In Phase |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 22, 2020 | May 18, 2023 |
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| 0-6 months |
| Fear of Hypoglycemic Events Change | To evaluate the change from baseline in the fear of hypoglycemic events based on the Hypoglycemia Fear Survey (HFS) | 0-6 months |
| Treatment Satisfaction Score | To evaluate the treatment satisfaction score based on the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) | 0-6 months |
| Glycemic Parameters Changes | To evaluate the change in glycemic parameters: mean time of sensor glucose values below 70mg/dL | 0-6 months |
| Glycemic Parameters Changes | To evaluate the change in glycemic parameters: mean time of sensor glucose values below 54mg/dL | 0-6 months |
| Glycemic Parameters Changes | To evaluate the change in glycemic parameters: mean time of sensor glucose values above 180mg/dL | 0-6 months |
| Glycemic Parameters Changes | To evaluate the change in glycemic parameters: mean time of sensor glucose values above above 250mg/dL | 0-6 months |
| HbA1c | To evaluate the change in glycosylated haemoglobin (HbA1c), between baseline and 6 months. | 0-6 months |
| Time in Range of 70-180 mg/dL (TIR) | The change in (%) the time spent within range, defined as the proportion of sensor glucose concentration within the target range of 70-180 mg/dL, between baseline and 12 months. | 0-12 months |
| HbA1c | To evaluate the change in glycosylated haemoglobin (HbA1c), between baseline and 12 months. | 0-12 months |
| Besançon |
| France |
| APHP Avicenne | Bobigny | France |
| CHU Bordeaux (Saint-André) | Bordeaux | France |
| CH Boulogne-Sur-Mer | Boulogne-sur-Mer | France |
| CHU Brest | Brest | France |
| HCL Groupement Hospitalier Est | Bron | France |
| CHU Caen | Caen | France |
| Ch Sud Francilien | Corbeil-Essonnes | France |
| CHU Dijon | Dijon | France |
| CHRU La Rochelle | La Rochelle | France |
| CHU Grenoble | La Tronche | France |
| CHU Lille | Lille | France |
| CHU Limoges | Limoges | France |
| HCL DIAB-eCARE | Lyon | France |
| IDNC Chartres | Mainvilliers | France |
| APHM Marseille (Hôpital de la Conception) | Marseille | France |
| APHM Marseille (La Timone) | Marseille | France |
| GHEF (Centre Hospitalier de Meaux) | Meaux | France |
| CHU Montpellier (Lapeyronie) | Montpellier | France |
| CHU Nantes | Nantes | France |
| CHU Nice | Nice | France |
| CHU Nîmes | Nîmes | France |
| APHP Bichat | Paris | France |
| APHP Cochin | Paris | France |
| Ch Lariboisiere | Paris | France |
| CH Perpignan | Perpignan | France |
| CH Périgueux | Périgueux | France |
| CHU Rennes | Rennes | France |
| CHU Strasbourg | Strasbourg | France |
| CHU Toulouse (Rangueil) | Toulouse | France |
| CHU Tours | Tours | France |
| COMPLETED |
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| NOT COMPLETED |
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| Study Phase 6-M |
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| Study Phase 12-M |
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All enrolled subjects, excluding Screen Failure
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| ID | Title | Description |
|---|---|---|
| BG000 | MiniMed™ 780G System | Subject will use the MiniMed™ 780G System as per standard of care. MiniMed™ 780G System: Subject enrolled in the study will start using the MiniMed™ 780G pump in Auto Mode after a run-in period of two weeks in Manual Mode (with no SmartGuard™ functions). Study phase in Automode will follow a 6 and 12 months follow- up as per standard of care. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| HbA1c | 2 subjects, out of 290, with missing HbA1c information at baseline | Mean | Standard Deviation | % |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Time in Range 70-180 mg/dL (TIR) | The change in (%) the time spent within range, defined as the proportion of sensor glucose concentration within the target range of 70-180 mg/dL, between baseline and 6 months. | Out of 290 subjects enrolled (excluding screen failure), 263 subjects, with both baseline and 6-M Follow Up measurements available were included in the analysis | Posted | Mean | 95% Confidence Interval | % of time | 0-6 months |
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| Secondary | Satisfaction Score | To evaluate the change from baseline in satisfaction score based on the Diabetes Treatment Satisfaction Questionnaire change (DTSQc) | Not Posted | 0-6 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life Change | To evaluate the change in quality of life based on the Diabetes Quality of life questionnaire (DQoL) | Not Posted | 0-6 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Fear of Hypoglycemic Events Change | To evaluate the change from baseline in the fear of hypoglycemic events based on the Hypoglycemia Fear Survey (HFS) | Not Posted | 0-6 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Satisfaction Score | To evaluate the treatment satisfaction score based on the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) | Not Posted | 0-6 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Glycemic Parameters Changes | To evaluate the change in glycemic parameters: mean time of sensor glucose values below 70mg/dL | Not Posted | 0-6 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Glycemic Parameters Changes | To evaluate the change in glycemic parameters: mean time of sensor glucose values below 54mg/dL | Not Posted | 0-6 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Glycemic Parameters Changes | To evaluate the change in glycemic parameters: mean time of sensor glucose values above 180mg/dL | Not Posted | 0-6 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Glycemic Parameters Changes | To evaluate the change in glycemic parameters: mean time of sensor glucose values above above 250mg/dL | Not Posted | 0-6 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | HbA1c | To evaluate the change in glycosylated haemoglobin (HbA1c), between baseline and 6 months. | Posted | Mean | Standard Deviation | Hba1c % | 0-6 months |
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| Secondary | Time in Range of 70-180 mg/dL (TIR) | The change in (%) the time spent within range, defined as the proportion of sensor glucose concentration within the target range of 70-180 mg/dL, between baseline and 12 months. | Posted | Mean | 95% Confidence Interval | % of time | 0-12 months |
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| Secondary | HbA1c | To evaluate the change in glycosylated haemoglobin (HbA1c), between baseline and 12 months. | Posted | Mean | Standard Deviation | Hba1c % | 0-12 months |
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Adverse Events were not collected. For this reason we reported 0/0 in the mandatory numeric fields below.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MiniMed™ 780G System | Subject will use the MiniMed™ 780G System as per standard of care. MiniMed™ 780G System: Subject enrolled in the study will start using the MiniMed™ 780G pump in Auto Mode after a run-in period of two weeks in Manual Mode (with no SmartGuard™ functions). Study phase in Automode will follow a 6 and 12 months follow- up as per standard of care. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fabio Di Piazza | Medtronic Diabetes | +393456172157 | fabio.di.piazza@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2022 | May 18, 2023 | SAP_001.pdf |
| 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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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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