Trial Outcomes & Findings for Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy (NCT NCT01921322)
NCT ID: NCT01921322
Last Updated: 2017-07-06
Results Overview
length of time to achieve target glucose range using Self-Monitoring Blood Glucose (SMBG), as reference method, with the 722 Paradigm Real-Time insulin pump versus Multiple Daily Injection
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
Up to 14 days in hospital
Results posted on
2017-07-06
Participant Flow
Participant milestones
| Measure |
Pump
Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
|
Multiple Daily Injections
Multiple daily insulin injections used for treatment
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
61
|
|
Overall Study
COMPLETED
|
42
|
44
|
|
Overall Study
NOT COMPLETED
|
15
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy
Baseline characteristics by cohort
| Measure |
Pump
n=40 Participants
Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
|
Multiple Daily Injections
n=41 Participants
Multiple daily insulin injections used for treatment
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 10.2 • n=99 Participants
|
49 years
STANDARD_DEVIATION 9.6 • n=107 Participants
|
50 years
STANDARD_DEVIATION 9.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
40 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Height (cm)
|
167 cm
STANDARD_DEVIATION 8.1 • n=99 Participants
|
168 cm
STANDARD_DEVIATION 7.6 • n=107 Participants
|
167 cm
STANDARD_DEVIATION 7.8 • n=206 Participants
|
|
Weight (kg)
|
71 kg
STANDARD_DEVIATION 11.9 • n=99 Participants
|
72 kg
STANDARD_DEVIATION 10.7 • n=107 Participants
|
71 kg
STANDARD_DEVIATION 11.2 • n=206 Participants
|
|
BMI (kg/m2)
|
25 kg/m2
STANDARD_DEVIATION 3.1 • n=99 Participants
|
25 kg/m2
STANDARD_DEVIATION 3.3 • n=107 Participants
|
25 kg/m2
STANDARD_DEVIATION 3.1 • n=206 Participants
|
|
A1C (%)
|
10 %
STANDARD_DEVIATION 1.6 • n=99 Participants
|
10 %
STANDARD_DEVIATION 1.2 • n=107 Participants
|
10 %
STANDARD_DEVIATION 1.4 • n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 14 days in hospitalPopulation: subjects included in final analysis
length of time to achieve target glucose range using Self-Monitoring Blood Glucose (SMBG), as reference method, with the 722 Paradigm Real-Time insulin pump versus Multiple Daily Injection
Outcome measures
| Measure |
Pump
n=40 Participants
Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
|
Multiple Daily Injections
n=41 Participants
Multiple daily insulin injections used for treatment
|
|---|---|---|
|
Time to Target
|
3.7 days
Standard Deviation 1.1
|
6.3 days
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Up to 14 days in hospitalPopulation: subjects incluced in final analysis
Glycemic variability (mean amplitude glycemic excursion) using CGM as reference method
Outcome measures
| Measure |
Pump
n=40 Participants
Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
|
Multiple Daily Injections
n=41 Participants
Multiple daily insulin injections used for treatment
|
|---|---|---|
|
Glycemic Variability
|
3.55 mmol/L
Standard Deviation 1.89
|
3.44 mmol/L
Standard Deviation 1.85
|
Adverse Events
Pump
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Multiple Daily Injections
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pump
n=57 participants at risk
Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
|
Multiple Daily Injections
n=61 participants at risk
Multiple daily insulin injections used for treatment
|
|---|---|---|
|
General disorders
bleeding
|
1.8%
1/57 • Number of events 1 • up to 14 days in hospital
|
0.00%
0/61 • up to 14 days in hospital
|
|
Immune system disorders
allergic reaction
|
0.00%
0/57 • up to 14 days in hospital
|
1.6%
1/61 • Number of events 1 • up to 14 days in hospital
|
|
Infections and infestations
infection
|
0.00%
0/57 • up to 14 days in hospital
|
1.6%
1/61 • Number of events 1 • up to 14 days in hospital
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place