Trial Outcomes & Findings for Qingdao: Insulin Pump Follow-Up Program (NCT NCT02655666)
NCT ID: NCT02655666
Last Updated: 2019-07-11
Results Overview
The change of A1C from baseline to end of study (1 year) will be presented
TERMINATED
16 participants
Change in A1C from baseline to end of study (1 year)
2019-07-11
Participant Flow
Participant milestones
| Measure |
Medtronic MiniMed Paradigm® REAL-Time System
Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Medtronic MiniMed Paradigm® REAL-Time System
Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
|
|---|---|
|
Overall Study
Sponsor stopped this clinical research.
|
12
|
Baseline Characteristics
Qingdao: Insulin Pump Follow-Up Program
Baseline characteristics by cohort
| Measure |
Medtronic MiniMed Paradigm® REAL-Time System
n=16 Participants
Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
|
|---|---|
|
Age, Continuous
|
11.3 years
STANDARD_DEVIATION 2.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change in A1C from baseline to end of study (1 year)Population: Subject completed the study.
The change of A1C from baseline to end of study (1 year) will be presented
Outcome measures
| Measure |
Medtronic MiniMed Paradigm® REAL-Time System
n=4 Participants
Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
|
|---|---|
|
Change in Glycosylated Hemoglobin (A1C)
|
0.9 percent Glycosylated Hemoglobin
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).Population: Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).
The average glucose value of all available glucose value of each subject for each evaluation period is calculated, and we present the mean and std of the individual average glucose value for each evaluation period.
Outcome measures
| Measure |
Medtronic MiniMed Paradigm® REAL-Time System
n=16 Participants
Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
|
|---|---|
|
Average Glucose Values Based on Continuous Glucose Monitoring Data
Month 12
|
8.0 mmol/L
Standard Deviation 0.39
|
|
Average Glucose Values Based on Continuous Glucose Monitoring Data
Baseline
|
9.8 mmol/L
Standard Deviation 2.87
|
|
Average Glucose Values Based on Continuous Glucose Monitoring Data
Month 6
|
10.4 mmol/L
Standard Deviation 3.01
|
|
Average Glucose Values Based on Continuous Glucose Monitoring Data
Month 9
|
9.5 mmol/L
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: Data is collected 7 days following the end of each period (At end of month 3, no glucose data is collected.).Population: Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).
The standard deviation of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual standard deviation for each evaluation period.
Outcome measures
| Measure |
Medtronic MiniMed Paradigm® REAL-Time System
n=16 Participants
Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
|
|---|---|
|
Standard Deviation of Glucose Value Based on Continuous Glucose Monitoring Data
Baseline
|
3.5 mmol/L
Standard Deviation 0.91
|
|
Standard Deviation of Glucose Value Based on Continuous Glucose Monitoring Data
Month 6
|
3.0 mmol/L
Standard Deviation 0.67
|
|
Standard Deviation of Glucose Value Based on Continuous Glucose Monitoring Data
Month 9
|
3.0 mmol/L
Standard Deviation 1.28
|
|
Standard Deviation of Glucose Value Based on Continuous Glucose Monitoring Data
Month 12
|
2.0 mmol/L
Standard Deviation 1.37
|
SECONDARY outcome
Timeframe: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).Population: Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).
The coefficient of variation of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual coefficient of variation for each evaluation period.
Outcome measures
| Measure |
Medtronic MiniMed Paradigm® REAL-Time System
n=16 Participants
Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
|
|---|---|
|
Coefficient of Variation of Glucose Value Per Each Subject Based on Continuous Glucose Monitoring Data
Baseline
|
36.3 percentage
Standard Deviation 6.49
|
|
Coefficient of Variation of Glucose Value Per Each Subject Based on Continuous Glucose Monitoring Data
Month 6
|
30.5 percentage
Standard Deviation 8.43
|
|
Coefficient of Variation of Glucose Value Per Each Subject Based on Continuous Glucose Monitoring Data
Month 9
|
31.0 percentage
Standard Deviation 7.33
|
|
Coefficient of Variation of Glucose Value Per Each Subject Based on Continuous Glucose Monitoring Data
Month 12
|
24.3 percentage
Standard Deviation 16.45
|
SECONDARY outcome
Timeframe: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).Population: Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).
Mean Amplitude of Glycemic Excursion (which is often used to characterize glycemic variability, to know the detail of calculation, please refer to "Glucose Variability, © 2013 by the American Diabetes Association." ) of each subject for each evaluation period is calculated, and then we present the mean and std of the individual Mean Amplitude of Glycemic Excursion for each evaluation period.
Outcome measures
| Measure |
Medtronic MiniMed Paradigm® REAL-Time System
n=16 Participants
Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
|
|---|---|
|
Mean Amplitude of Glycemic Excursion Based on Continuous Glucose Monitoring Data
Baseline
|
6.9 mmol/L
Standard Deviation 2.51
|
|
Mean Amplitude of Glycemic Excursion Based on Continuous Glucose Monitoring Data
Month 6
|
6.8 mmol/L
Standard Deviation 1.79
|
|
Mean Amplitude of Glycemic Excursion Based on Continuous Glucose Monitoring Data
Month 9
|
6.7 mmol/L
Standard Deviation 3.22
|
|
Mean Amplitude of Glycemic Excursion Based on Continuous Glucose Monitoring Data
Month 12
|
5.5 mmol/L
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).Population: Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).
Number of events in the hypoglycemic range (SG≤3.9mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual number of events for each evaluation period.
Outcome measures
| Measure |
Medtronic MiniMed Paradigm® REAL-Time System
n=16 Participants
Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
|
|---|---|
|
Number of Events in the Hypoglycemic Range
Baseline SG≤3.9mmol/L
|
0.5 events
Standard Deviation 0.60
|
|
Number of Events in the Hypoglycemic Range
Month 6 SG≤3.9mmol/L
|
0.3 events
Standard Deviation 0.54
|
|
Number of Events in the Hypoglycemic Range
Month 9 SG≤3.9mmol/L
|
0.1 events
Standard Deviation 0.21
|
|
Number of Events in the Hypoglycemic Range
Month 12 SG≤3.9mmol/L
|
0.2 events
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).Population: Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).
Number of Events in the Hyperglycemic Range (SG≥10.0 mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual number of events for each evaluation period.
Outcome measures
| Measure |
Medtronic MiniMed Paradigm® REAL-Time System
n=16 Participants
Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
|
|---|---|
|
Number of Events in the Hyperglycemic Range
Baseline SG≥10.0 mmol/L
|
1.4 events
Standard Deviation 0.73
|
|
Number of Events in the Hyperglycemic Range
Month 6 SG≥10.0 mmol/L
|
1.4 events
Standard Deviation 0.46
|
|
Number of Events in the Hyperglycemic Range
Month 9 SG≥10.0 mmol/L/L
|
1.8 events
Standard Deviation 0.83
|
|
Number of Events in the Hyperglycemic Range
Month 12 SG≥10.0 mmol/L
|
1.1 events
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).Population: Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).
Area under Curve in the hypoglycemic range (SG≤3.9mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual Area under Curve for each evaluation period.
Outcome measures
| Measure |
Medtronic MiniMed Paradigm® REAL-Time System
n=16 Participants
Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
|
|---|---|
|
Area Under Curve in the Hypoglycemic Range
Baseline SG≤3.9 mmol/L
|
0.03 mmol/L*min
Standard Deviation 0.04
|
|
Area Under Curve in the Hypoglycemic Range
Month 6 SG≤3.9 mmol/L
|
0.01 mmol/L*min
Standard Deviation 0.03
|
|
Area Under Curve in the Hypoglycemic Range
Month 9 SG≤3.9 mmol/L
|
0.00 mmol/L*min
Standard Deviation 0.01
|
|
Area Under Curve in the Hypoglycemic Range
Month 12 SG≤3.9 mmol/L
|
0.00 mmol/L*min
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).Population: Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).
Area under Curve in the hyperglycemic range (SG≥10.0 mmol/L) based on all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual Area under Curve for each evaluation period.
Outcome measures
| Measure |
Medtronic MiniMed Paradigm® REAL-Time System
n=16 Participants
Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
|
|---|---|
|
Area Under Curve in the Hyperglycemic Range
Baseline SG≥10.0 mmol/L
|
1.80 mmol/L*min
Standard Deviation 1.55
|
|
Area Under Curve in the Hyperglycemic Range
Month 6 SG≥10.0 mmol/L
|
1.94 mmol/L*min
Standard Deviation 1.85
|
|
Area Under Curve in the Hyperglycemic Range
Month 9 SG≥10.0 mmol/L
|
1.30 mmol/L*min
Standard Deviation 1.36
|
|
Area Under Curve in the Hyperglycemic Range
Month 12 SG≥10.0 mmol/L
|
0.32 mmol/L*min
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).Population: Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).
Percentage of time in the hypoglycemic range (SG ≤ 3.9 mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual percetage of time in that range for each evaluation period.
Outcome measures
| Measure |
Medtronic MiniMed Paradigm® REAL-Time System
n=16 Participants
Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
|
|---|---|
|
Percentage of Time in the Hypoglycemic Range
Baseline SG ≤ 3.9 mmol/L
|
5.4 percentage of time
Standard Deviation 6.87
|
|
Percentage of Time in the Hypoglycemic Range
Month 6 SG ≤ 3.9 mmol/L
|
1.8 percentage of time
Standard Deviation 4.31
|
|
Percentage of Time in the Hypoglycemic Range
Month 9 SG ≤ 3.9 mmol/L
|
0.6 percentage of time
Standard Deviation 1.26
|
|
Percentage of Time in the Hypoglycemic Range
Month 12 SG ≤ 3.9 mmol/L
|
0.6 percentage of time
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).Population: Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).
Percentage of time in the hyperglycemic range (SG≥10.0 mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual percentage of time in that range for each evaluation period.
Outcome measures
| Measure |
Medtronic MiniMed Paradigm® REAL-Time System
n=16 Participants
Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
|
|---|---|
|
Percentage of Time in the Hyperglycemic Range
Baseline SG ≥ 10.0 mmol/L
|
44.1 percentage of time
Standard Deviation 29.38
|
|
Percentage of Time in the Hyperglycemic Range
Month 6 SG ≥ 10.0 mmol/L
|
47.5 percentage of time
Standard Deviation 32.87
|
|
Percentage of Time in the Hyperglycemic Range
Month 9 SG ≥ 10.0 mmol/L
|
36.6 percentage of time
Standard Deviation 24.50
|
|
Percentage of Time in the Hyperglycemic Range
Month 12 SG ≥ 10.0 mmol/L
|
16.0 percentage of time
Standard Deviation 14.77
|
Adverse Events
Medtronic MiniMed Paradigm® REAL-Time System
Serious adverse events
| Measure |
Medtronic MiniMed Paradigm® REAL-Time System
n=16 participants at risk
Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
|
|---|---|
|
Metabolism and nutrition disorders
Severe Hyperglycemia
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
hyperglycemia
|
6.2%
1/16 • Number of events 1 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60