Trial Outcomes & Findings for Insulin Delivery Using Microneedles in Type 1 Diabetes (NCT NCT00837512)

NCT ID: NCT00837512

Last Updated: 2014-01-08

Results Overview

Average time to peak insulin concentration

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 16 participants
• Primary outcome timeframe: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours
• Results posted on: 2014-01-08

Participant Flow

Subjects were recruited from our outpatient clinic setting within the Emory Children's Center

In the event that the potential subject was on Humalog they switched to Novolog 48 hours prior to first visit.

Participant milestones

Measure	First: Microneedle Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers	First: Subcutaneous Insulin Catheter Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
First Intervention (6hrs) - RANDOMIZED STARTED	8	8
First Intervention (6hrs) - RANDOMIZED COMPLETED	8	8
First Intervention (6hrs) - RANDOMIZED NOT COMPLETED	0	0
Both Arms: Washout (7-28 Days) STARTED	8	8
Both Arms: Washout (7-28 Days) COMPLETED	8	8
Both Arms: Washout (7-28 Days) NOT COMPLETED	0	0
2nd Intervention (6 Hrs) - RANDOMIZED STARTED	8	8
2nd Intervention (6 Hrs) - RANDOMIZED COMPLETED	8	8
2nd Intervention (6 Hrs) - RANDOMIZED NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Insulin Delivery Using Microneedles in Type 1 Diabetes

Baseline characteristics by cohort

Measure	Entire Study Population n=16 Participants Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
Age, Categorical <=18 years	16 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	14.61 years STANDARD_DEVIATION 2.19 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants
Microneedle Female	7 Participants n=5 Participants
Microneedle Male	9 Participants n=5 Participants
Subcutaneous insulin catheter Female	7 participants n=5 Participants
Subcutaneous insulin catheter Male	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours

Average time to peak insulin concentration

Outcome measures

Measure	Microneedle n=12 Participants Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers	Subcutaneous Insulin Catheter n=12 Participants Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
Onset Time (Tmax)	30 Minutes Standard Deviation 2	52 Minutes Standard Deviation 4

Adverse Events

Microneedle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Subcutaneous Insulin Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Eric Felner

Emory University School of Medicine

Phone: 404-727-7651

Email: efelner@emory.edu

Results disclosure agreements

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