Trial Outcomes & Findings for Post Approval Study of the TS Feature With the 530G Pump System Supplemented With Commercial Patient Data (NCT NCT02003898)
NCT ID: NCT02003898
Last Updated: 2019-03-05
Results Overview
Comparison of A1C measurement from baseline to end of study in the CEP266 study population. The overall mean change in A1C from baseline will be estimated and compared by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided) with the CEP 266 study population.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
372 participants
Primary outcome timeframe
1 year
Results posted on
2019-03-05
Participant Flow
Participant milestones
| Measure |
Medtronic MiniMed 530G Insulin Pump
All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.
Medtronic MiniMed 530G Insulin Pump
|
|---|---|
|
Overall Study
STARTED
|
372
|
|
Overall Study
COMPLETED
|
305
|
|
Overall Study
NOT COMPLETED
|
67
|
Reasons for withdrawal
| Measure |
Medtronic MiniMed 530G Insulin Pump
All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.
Medtronic MiniMed 530G Insulin Pump
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Lost to Follow-up
|
12
|
|
Overall Study
Withdrawal by Subject
|
52
|
Baseline Characteristics
Post Approval Study of the TS Feature With the 530G Pump System Supplemented With Commercial Patient Data
Baseline characteristics by cohort
| Measure |
Medtronic MiniMed 530G Insulin Pump
n=372 Participants
All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.
Medtronic MiniMed 530G Insulin Pump
|
|---|---|
|
Age, Continuous
|
45.5 Years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
201 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
171 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
351 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
372 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Among the 372 enrolled subjects, 298 had both baseline and end of study A1c.
Comparison of A1C measurement from baseline to end of study in the CEP266 study population. The overall mean change in A1C from baseline will be estimated and compared by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided) with the CEP 266 study population.
Outcome measures
| Measure |
Medtronic MiniMed 530G Insulin Pump
n=298 Participants
All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.
Medtronic MiniMed 530G Insulin Pump
|
|---|---|
|
Mean Change in A1C From Baseline to 1 Year
|
0.034 percentage
Interval -0.03 to 0.098
|
SECONDARY outcome
Timeframe: 1 yearMean Change in A1C From Baseline to 1 Year, for subjects with baseline A1c below 7%.
Outcome measures
| Measure |
Medtronic MiniMed 530G Insulin Pump
n=83 Participants
All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.
Medtronic MiniMed 530G Insulin Pump
|
|---|---|
|
Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7%
|
0.32 percentage
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: 1 yearMean Change in A1C From Baseline to 1 Year, for subjects with Baseline A1c of 7% to 9%
Outcome measures
| Measure |
Medtronic MiniMed 530G Insulin Pump
n=187 Participants
All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.
Medtronic MiniMed 530G Insulin Pump
|
|---|---|
|
Mean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9%
|
-0.04 percentage
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: 1 yearMean Change in A1C From Baseline to 1 year, for subjects with Baseline A1c \> 9%
Outcome measures
| Measure |
Medtronic MiniMed 530G Insulin Pump
n=28 Participants
All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.
Medtronic MiniMed 530G Insulin Pump
|
|---|---|
|
Mean Change in A1C From Baseline to 1 Year, Baseline A1c > 9%
|
-0.39 percentage
Standard Deviation 0.96
|
Adverse Events
Medtronic MiniMed 530G Insulin Pump
Serious events: 19 serious events
Other events: 37 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Medtronic MiniMed 530G Insulin Pump
n=372 participants at risk
All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.
Medtronic MiniMed 530G Insulin Pump
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Nervous system disorders
Altered state of consciousness
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
General disorders
Chest pain
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
General disorders
Death
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
1.3%
5/372 • Number of events 5 • 1 year
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.1%
4/372 • Number of events 4 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mixed hepatocellular cholangiocarcinoma
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.27%
1/372 • Number of events 4 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
0.27%
1/372 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Medtronic MiniMed 530G Insulin Pump
n=372 participants at risk
All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.
Medtronic MiniMed 530G Insulin Pump
|
|---|---|
|
Infections and infestations
Abscess limb
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Infections and infestations
Cellulitis
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Contusion
|
0.54%
2/372 • Number of events 3 • 1 year
|
|
Nervous system disorders
Convulsion
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Infections and infestations
Dermatophytosis
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.7%
10/372 • Number of events 13 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.1%
4/372 • Number of events 4 • 1 year
|
|
General disorders
Infusion site erythema
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Infections and infestations
Infusion site infection
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Ketonuria
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
General disorders
Medical device site reaction
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
General disorders
Puncture site haemorrhage
|
2.4%
9/372 • Number of events 14 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Scar
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Nervous system disorders
Sciatica
|
0.27%
1/372 • Number of events 1 • 1 year
|
|
Infections and infestations
Skin infection
|
0.54%
2/372 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.54%
2/372 • Number of events 2 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60