Trial Outcomes & Findings for Real-life Data From Diabetic Patients on Closed-loop Pumps (NCT NCT05418699)
NCT ID: NCT05418699
Last Updated: 2026-03-12
Results Overview
Hemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6%
Recruitment status
COMPLETED
Target enrollment
410 participants
Primary outcome timeframe
At 3 months
Results posted on
2026-03-12
Participant Flow
Participant milestones
| Measure |
Type I Diabetic Patient
Patients with a confirmed diagnosis of type 1 diabetes mellitus (T1DM) who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Overall Study
STARTED
|
410
|
|
Overall Study
3 Months
|
410
|
|
Overall Study
6 Months
|
406
|
|
Overall Study
12 Months
|
401
|
|
Overall Study
COMPLETED
|
391
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Type I Diabetic Patient
Patients with a confirmed diagnosis of type 1 diabetes mellitus (T1DM) who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Overall Study
Discontinue of the closed-loop system
|
11
|
|
Overall Study
Lost to Follow-up
|
8
|
Baseline Characteristics
Real-life Data From Diabetic Patients on Closed-loop Pumps
Baseline characteristics by cohort
| Measure |
Type I Diabetic Patient
n=410 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
344 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
56 Participants
n=9 Participants
|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 16 • n=9 Participants
|
|
Sex: Female, Male
Female
|
238 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
172 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
410 Participants
n=9 Participants
|
|
Region of Enrollment
France
|
410 participants
n=9 Participants
|
|
Body mass index
|
27 kg^m2
STANDARD_DEVIATION 5.8 • n=9 Participants
|
|
HbA1c level
|
7.5 percentage of HBA1c
STANDARD_DEVIATION 0.9 • n=9 Participants
|
|
Time in range
|
64 percentage of time spent in range
STANDARD_DEVIATION 13.2 • n=9 Participants
|
|
Time below range
|
3 percentage of time spent below range
STANDARD_DEVIATION 3.5 • n=9 Participants
|
|
Time above range
|
31 percentage of time spent above range
STANDARD_DEVIATION 13.6 • n=9 Participants
|
|
Coefficient of variation
|
35 percentage of coefficient of variation
STANDARD_DEVIATION 5.5 • n=9 Participants
|
PRIMARY outcome
Timeframe: At 3 monthsHemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6%
Outcome measures
| Measure |
Type I Diabetic Patient
n=410 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
HbA1c Level
|
6.9 percentage of HBA1c
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: At 6 monthsHemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6%
Outcome measures
| Measure |
Type I Diabetic Patient
n=406 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
HbA1c Level
|
7.0 percentage of HBA1c
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: At 12 monthsHemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6%
Outcome measures
| Measure |
Type I Diabetic Patient
n=401 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
HbA1c Level
|
7.0 percentage of HBA1c
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: At 3 monthsPercentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days
Outcome measures
| Measure |
Type I Diabetic Patient
n=410 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Time in Range
|
75 percentage of time spent in range
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: At 6 monthsPercentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days
Outcome measures
| Measure |
Type I Diabetic Patient
n=406 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Time in Range
|
74 percentage of time spent in range
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: At 12 monthsPercentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days
Outcome measures
| Measure |
Type I Diabetic Patient
n=401 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Time in Range
|
74 percentage of time spent in range
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: At 3 monthsPercentage of time with glucose values below 70 mg/dL in the last 14 days
Outcome measures
| Measure |
Type I Diabetic Patient
n=410 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Time Below Range
|
2 percentage of time spent below range
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: At 6 monthsPercentage of time with glucose values below 70 mg/dL in the last 14 days
Outcome measures
| Measure |
Type I Diabetic Patient
n=406 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Time Below Range
|
2 percentage of time spent below range
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: At 12 monthsPercentage of time with glucose values below 70 mg/dL in the last 14 days
Outcome measures
| Measure |
Type I Diabetic Patient
n=401 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Time Below Range
|
2 percentage of time spent below range
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: At 3 monthsPercentage of time with glucose values above 180 mg/dL in the last 14 days
Outcome measures
| Measure |
Type I Diabetic Patient
n=410 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Time Above Range
|
22 percentage of time spent above range
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: At 6 monthsPercentage of time with glucose values above 180 mg/dL in the last 14 days
Outcome measures
| Measure |
Type I Diabetic Patient
n=406 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Time Above Range
|
22 percentage of time spent above range
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: At 12 monthsPercentage of time with glucose values above 180 mg/dL in the last 14 days
Outcome measures
| Measure |
Type I Diabetic Patient
n=401 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Time Above Range
|
23 percentage of time spent above range
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: At 3 monthsRatio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)
Outcome measures
| Measure |
Type I Diabetic Patient
n=410 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Coefficient of Variation
|
33 percentage of coefficient of variation
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: At 6 monthsRatio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)
Outcome measures
| Measure |
Type I Diabetic Patient
n=406 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Coefficient of Variation
|
33 percentage of coefficient of variation
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: At 12 monthsRatio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)
Outcome measures
| Measure |
Type I Diabetic Patient
n=401 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Coefficient of Variation
|
33 percentage of coefficient of variation
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: at 18 monthsHemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6%
Outcome measures
| Measure |
Type I Diabetic Patient
n=391 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
HbA1c Level
|
7.1 percentage of HBA1c
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: at 18 monthsPercentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days
Outcome measures
| Measure |
Type I Diabetic Patient
n=391 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Time in Range
|
73 percentage of HBA1c
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: at 18 monthsPercentage of time with glucose values below 70 mg/dL in the last 14 days
Outcome measures
| Measure |
Type I Diabetic Patient
n=391 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Time Below Range
|
2 percentage of time spent below range
Standard Error 1.6
|
SECONDARY outcome
Timeframe: at 18 monthsPercentage of time with glucose values above 180 mg/dL in the last 14 days
Outcome measures
| Measure |
Type I Diabetic Patient
n=391 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Time Above Range
|
24 percentage of time spent above range
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: at 18 monthsRatio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)
Outcome measures
| Measure |
Type I Diabetic Patient
n=391 Participants
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Coefficient of Variation
|
33 percentage of coefficient of variation
Standard Deviation 6.5
|
Adverse Events
Type I Diabetic Patient
Serious events: 26 serious events
Other events: 184 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Type I Diabetic Patient
n=410 participants at risk
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Endocrine disorders
Severe hypoglycemia
|
2.0%
8/410 • Number of events 15 • 18 months
|
|
Endocrine disorders
Ketoacidaemia
|
2.0%
8/410 • Number of events 9 • 18 months
|
|
Endocrine disorders
Hospitalisation
|
4.4%
18/410 • Number of events 20 • 18 months
|
Other adverse events
| Measure |
Type I Diabetic Patient
n=410 participants at risk
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
|
|---|---|
|
Endocrine disorders
Medical device change
|
3.9%
16/410 • Number of events 16 • 18 months
|
|
Endocrine disorders
Device end of service
|
8.3%
34/410 • Number of events 34 • 18 months
|
|
Endocrine disorders
Device defective
|
21.7%
89/410 • Number of events 410 • 18 months
|
Additional Information
Dr. Didier Gouet
Groupe Hospitalier de la Rochelle Ré Aunis
Phone: +335 46 45 51 31
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place