Trial Outcomes & Findings for Use of iPro™2 in Real Life Diabetes Management of Type 2 Patients in India (NCT NCT01995539)

NCT ID: NCT01995539

Last Updated: 2018-12-04

Results Overview

Descriptive analysis of change in A1C from baseline to end of 3-month study period

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 181 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2018-12-04

Participant Flow

Participant milestones

Measure	iPro2 Use All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
Overall Study STARTED	181
Overall Study COMPLETED	148
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Measure	iPro2 Use All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
Overall Study Screening Failure	1
Overall Study Withdrawal by Investigator	15
Overall Study Withdrawal by Subject	11
Overall Study Lost to Follow-up	5
Overall Study Subject missed visit 3,4, came in for V5	1

Baseline Characteristics

Use of iPro™2 in Real Life Diabetes Management of Type 2 Patients in India

Baseline characteristics by cohort

Measure	iPro2 Use n=181 Participants All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
Age, Continuous	54.1 Years STANDARD_DEVIATION 10.06 • n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants
Sex: Female, Male Male	111 Participants n=5 Participants
Region of Enrollment India	181 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: 181 subjects consented and screened; 1 subject screen failed; 148 subjects completed study; 32 subjects not completed study.

Descriptive analysis of change in A1C from baseline to end of 3-month study period

Outcome measures

Measure	iPro2 Use n=148 Participants All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
Change From Baseline in A1C at 3 Months	-0.6 percent Standard Deviation 1.11

SECONDARY outcome

Timeframe: 3 months

Evaluation of incidence of SADE during the study.

Outcome measures

Measure	iPro2 Use n=181 Participants All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
Number of Serious Adverse Device Effects (SADE).	0 events

Adverse Events

iPro2 Use

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	iPro2 Use n=181 participants at risk All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
Skin and subcutaneous tissue disorders Pricking sensation at insertion site	0.55% 1/181 • Number of events 1 • 3 Month
General disorders BLEEDING AT SENSOR INSERTION SITE	0.55% 1/181 • Number of events 1 • 3 Month
Skin and subcutaneous tissue disorders itching at sensor insertion site	1.1% 2/181 • Number of events 2 • 3 Month
General disorders Pain at insertion site area	1.1% 2/181 • Number of events 2 • 3 Month
Skin and subcutaneous tissue disorders Skin irritation at sensor insertion site	0.55% 1/181 • Number of events 1 • 3 Month

Additional Information

Suiying Huang, Statistician

Medtronic Minimed

Phone: 8184763319

Email: suiying.huang@medtronic.com

Results disclosure agreements

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

Restriction type: GT60