Trial Outcomes & Findings for The MiniMed™ 780G Glycemic Control and Quality of Life Study for the Treatment of Pediatric and Adult Subjects With Type 1 Diabetes in France. (NCT NCT04308291)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

306 participants

Primary outcome timeframe

0-6 months

Results posted on

2024-07-08

Participant Flow

Date of first subject enrollment: 15-FEB-2021, Date of last data received: 23-NOV-2022

306 subjects with type 1 diabetes consented to participate in the study. Of them, 16 subjects are Screen Failure.

Participant milestones

Participant milestones
Measure	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.
Run-In Phase STARTED	290
Run-In Phase COMPLETED	286
Run-In Phase NOT COMPLETED	4
Study Phase 6-M STARTED	286
Study Phase 6-M COMPLETED	270
Study Phase 6-M NOT COMPLETED	16
Study Phase 12-M STARTED	270
Study Phase 12-M COMPLETED	256
Study Phase 12-M NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Run-In Phase Withdrawal by Subject	4
Study Phase 6-M Withdrawal by Subject	13
Study Phase 6-M Physician Decision	2
Study Phase 6-M Carelink uploading issues (Linux user)	1
Study Phase 12-M Withdrawal by Subject	11
Study Phase 12-M Physician Decision	2
Study Phase 12-M Hospitalization for cause not related to the study (Pancytopenia)	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MiniMed™ 780G System n=290 Participants 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.
Age, Continuous	38.9 years STANDARD_DEVIATION 16.32 • n=290 Participants
Sex: Female, Male Female	160 Participants n=290 Participants
Sex: Female, Male Male	130 Participants n=290 Participants
Region of Enrollment France	290 Participants n=290 Participants
HbA1c	7.76 % STANDARD_DEVIATION 0.818 • n=288 Participants • 2 subjects, out of 290, with missing HbA1c information at baseline

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	MiniMed™ 780G System n=263 Participants 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.
Time in Range 70-180 mg/dL (TIR)	11.81 % of time Interval 10.72 to 12.9

SECONDARY outcome

Timeframe: 0-6 months

To evaluate the change from baseline in satisfaction score based on the Diabetes Treatment Satisfaction Questionnaire change (DTSQc)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-6 months

To evaluate the change in quality of life based on the Diabetes Quality of life questionnaire (DQoL)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-6 months

To evaluate the change from baseline in the fear of hypoglycemic events based on the Hypoglycemia Fear Survey (HFS)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-6 months

To evaluate the treatment satisfaction score based on the Diabetes Treatment Satisfaction Questionnaire status (DTSQs)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-6 months

To evaluate the change in glycemic parameters: mean time of sensor glucose values below 70mg/dL

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-6 months

To evaluate the change in glycemic parameters: mean time of sensor glucose values below 54mg/dL

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-6 months

To evaluate the change in glycemic parameters: mean time of sensor glucose values above 180mg/dL

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-6 months

To evaluate the change in glycemic parameters: mean time of sensor glucose values above above 250mg/dL

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-6 months

To evaluate the change in glycosylated haemoglobin (HbA1c), between baseline and 6 months.

Outcome measures

Outcome measures
Measure	MiniMed™ 780G System n=264 Participants 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.
HbA1c	-0.52 Hba1c % Standard Deviation 0.719

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MiniMed™ 780G System n=256 Participants 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.
Time in Range of 70-180 mg/dL (TIR)	11.09 % of time Interval 10.37 to 11.82

SECONDARY outcome

Timeframe: 0-12 months

To evaluate the change in glycosylated haemoglobin (HbA1c), between baseline and 12 months.

Outcome measures

Outcome measures
Measure	MiniMed™ 780G System n=251 Participants 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.
HbA1c	-0.42 Hba1c % Standard Deviation 0.754

Adverse Events

MiniMed™ 780G System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Fabio Di Piazza

Medtronic Diabetes

Phone: +393456172157

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place