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=5 Participants	49 years STANDARD_DEVIATION 9.6 • n=7 Participants	50 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	40 Participants n=5 Participants	41 Participants n=7 Participants	81 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Height (cm)	167 cm STANDARD_DEVIATION 8.1 • n=5 Participants	168 cm STANDARD_DEVIATION 7.6 • n=7 Participants	167 cm STANDARD_DEVIATION 7.8 • n=5 Participants
Weight (kg)	71 kg STANDARD_DEVIATION 11.9 • n=5 Participants	72 kg STANDARD_DEVIATION 10.7 • n=7 Participants	71 kg STANDARD_DEVIATION 11.2 • n=5 Participants
BMI (kg/m2)	25 kg/m2 STANDARD_DEVIATION 3.1 • n=5 Participants	25 kg/m2 STANDARD_DEVIATION 3.3 • n=7 Participants	25 kg/m2 STANDARD_DEVIATION 3.1 • n=5 Participants
A1C (%)	10 % STANDARD_DEVIATION 1.6 • n=5 Participants	10 % STANDARD_DEVIATION 1.2 • n=7 Participants	10 % STANDARD_DEVIATION 1.4 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 14 days in hospital

Population: 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 hospital

Population: 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

John Shin, PhD

Medtronic Diabetes

Phone: 818-576-4019

Email: john.shin@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place