Type 1 Diabetes
Conditions
Keywords
780G, T1D
Brief summary
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.
Detailed description
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: 1. RUN-IN PHASE: Subject will start a run-in phase in an out of hospital setting, as per standard practice of the site. The objective of the run-in phase is to train the subjects on the MiniMed™ 780G insulin pump, assess subjects' compliance and ability to comprehend the study procedures and tolerance of wearing the sensor and transmitter continuously. It is expected that during the run-in phase the MiniMed™ 780G insulin pump will be set in Manual mode and all the algorithms are switched off, and baseline Continuous Glucose Monitoring (CGM) data will be collected. The expected duration of the run-in phase is approximately 2 weeks. At the end of the run-in phase the MiniMed™ 780G insulin pump will be set in Auto Mode and the date of activation will be collected and identified as a start of the study phase. Data from the MiniMed™ 780G insulin pump will be uploaded in the CareLink™ as per standard practice, before Auto Mode activation. 2. 6 AND 12 MONTHS FOLLOW UP: Follow-up visits will be performed according to the therapy management standard of care at 6 and 12 months after Auto Mode activation in the study. Approximately 300 patients (children and adults) will be enrollment in the study in approximately 32 sites in France.
Interventions
DEVICEMiniMed™ 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.
Sponsors
Medtronic Diabetes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Inclusion criteria
1. Subject is ≥7 years of age. 2. Subject has a clinical diagnosis of type 1 diabetes for more than 1 year as determined via medical records or source documentation by an individual qualified to make a medical diagnosis. 3. Subject has a HbA1c value greater than 6.5% and less than 12% at time of enrolment visit. 4. Subject is under Continuous Subcutaneous Insulin Infusion (CSII) therapy (with or without Continuous Glucose Monitoring) ≥ 6 months before enrolment. 5. Subject requires ≥8 units of insulin per day. 6. Subjects and their parent(s)/guardian(s) must be able to speak and be literate in French as verified by the investigator. 7. Subjects and their parent(s)/guardian(s) are willing to participate in the study and sign the Data Release Form (DRF). 8. Subjects who are ≥18 years of age should be able to provide consent.
Exclusion criteria
1. Subject has MiniMed™ 780G System IFU contraindication(s). 2. Subject uses Predictive Low-Glucose Management (PLGM) System (i.e. MiniMed™ 640G with SmartGuard) in the last 6 months before the enrolment. 3. Subject uses Low Glucose suspend (LGS) feature (i.e. MiniMed™ Paradigm Veo Pump) in the last 6 months before the enrolment. 4. Subject under Multiple-Daily Injections (MDI) treatment in the 6 months before the enrolment. 5. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range 70-180 mg/dL (TIR) | 0-6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction Score | 0-6 months | To evaluate the change from baseline in satisfaction score based on the Diabetes Treatment Satisfaction Questionnaire change (DTSQc) |
| Quality of Life Change | 0-6 months | To evaluate the change in quality of life based on the Diabetes Quality of life questionnaire (DQoL) |
| Fear of Hypoglycemic Events Change | 0-6 months | To evaluate the change from baseline in the fear of hypoglycemic events based on the Hypoglycemia Fear Survey (HFS) |
| Treatment Satisfaction Score | 0-6 months | To evaluate the treatment satisfaction score based on the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) |
| Glycemic Parameters Changes | 0-6 months | To evaluate the change in glycemic parameters: mean time of sensor glucose values below 70mg/dL |
| HbA1c | 0-6 months | To evaluate the change in glycosylated haemoglobin (HbA1c), between baseline and 6 months. |
| Time in Range of 70-180 mg/dL (TIR) | 0-12 months | 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. |
Countries
France
Participant flow
Recruitment details
Date of first subject enrollment: 15-FEB-2021, Date of last data received: 23-NOV-2022
Pre-assignment details
306 subjects with type 1 diabetes consented to participate in the study. Of them, 16 subjects are Screen Failure.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 290 |
| Total | 290 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Run-In Phase | Withdrawal by Subject | 4 |
| Study Phase 12-M | Hospitalization for cause not related to the study (Pancytopenia) | 1 |
| Study Phase 12-M | Physician Decision | 2 |
| Study Phase 12-M | Withdrawal by Subject | 11 |
| Study Phase 6-M | Carelink uploading issues (Linux user) | 1 |
| Study Phase 6-M | Physician Decision | 2 |
| Study Phase 6-M | Withdrawal by Subject | 13 |
Baseline characteristics
| Characteristic | MiniMed™ 780G System | — |
|---|---|---|
| Age, Continuous | 38.9 years STANDARD_DEVIATION 16.32 | — |
| HbA1c | 7.76 % STANDARD_DEVIATION 0.818 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 290 Participants | — |
| Sex: Female, Male Female | 160 Participants | — |
| Sex: Female, Male Male | 130 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: 0-6 months
Population: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MiniMed™ 780G System | Time in Range 70-180 mg/dL (TIR) | 11.81 % of time |
p-value: <0.0001t-test, 2 sided
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)
Time frame: 0-6 months
Secondary
Glycemic Parameters Changes
To evaluate the change in glycemic parameters: mean time of sensor glucose values below 54mg/dL
Time frame: 0-6 months
Secondary
Glycemic Parameters Changes
To evaluate the change in glycemic parameters: mean time of sensor glucose values below 70mg/dL
Time frame: 0-6 months
Secondary
Glycemic Parameters Changes
To evaluate the change in glycemic parameters: mean time of sensor glucose values above 180mg/dL
Time frame: 0-6 months
Secondary
Glycemic Parameters Changes
To evaluate the change in glycemic parameters: mean time of sensor glucose values above above 250mg/dL
Time frame: 0-6 months
Secondary
HbA1c
To evaluate the change in glycosylated haemoglobin (HbA1c), between baseline and 12 months.
Time frame: 0-12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiniMed™ 780G System | HbA1c | -0.42 Hba1c % | Standard Deviation 0.754 |
Secondary
HbA1c
To evaluate the change in glycosylated haemoglobin (HbA1c), between baseline and 6 months.
Time frame: 0-6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiniMed™ 780G System | HbA1c | -0.52 Hba1c % | Standard Deviation 0.719 |
Secondary
Quality of Life Change
To evaluate the change in quality of life based on the Diabetes Quality of life questionnaire (DQoL)
Time frame: 0-6 months
Secondary
Satisfaction Score
To evaluate the change from baseline in satisfaction score based on the Diabetes Treatment Satisfaction Questionnaire change (DTSQc)
Time frame: 0-6 months
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.
Time frame: 0-12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MiniMed™ 780G System | Time in Range of 70-180 mg/dL (TIR) | 11.09 % of time |
Secondary
Treatment Satisfaction Score
To evaluate the treatment satisfaction score based on the Diabetes Treatment Satisfaction Questionnaire status (DTSQs)
Time frame: 0-6 months