Trial Outcomes & Findings for Clinical Assessment of a Novel Microprobe Array Continuous Glucose Monitor for Type 1 Diabetes (NCT NCT01908530)

Results Overview

The study aims to assess safety of the use of microprobe array continuous glucose sensor with regards to skin inflammation.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

24 hours

Results posted on

2019-11-20

Participant Flow

Phase 4 did not go ahead

Participant milestones

Participant milestones
Measure	Microprobe Glucose Sensor Phase 1 The microprobe array continuous glucose sensor applied to healthy volunteers for 6h	Microprobe Glucose Sensor Phase 2 The microprobe array continuous glucose sensor applied to healthy volunteers for 24 h	Microprobe Glucose Sensor Phase 3 The microprobe array continuous glucose sensor applied to participants with type 1 diabetes
Overall Study STARTED	8	8	10
Overall Study COMPLETED	8	8	10
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Assessment of a Novel Microprobe Array Continuous Glucose Monitor for Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Microprobe Glucose Sensor Phase 1 n=8 Participants The microprobe array continuous glucose sensor applied to healthy volunteers for 6 h	Microprobe Glucose Sensor Phase 2 n=8 Participants The microprobe array continuous glucose sensor will be applied to healthy volunteers for 24 h	Microprobe Glucose Sensor Phase 3 n=10 Participants The microprobe array continuous glucose sensor applied to participants with type 1 diabetes	Total n=26 Participants Total of all reporting groups
Age, Continuous	34.6 years STANDARD_DEVIATION 6.9 • n=5 Participants	34.6 years STANDARD_DEVIATION 6.9 • n=7 Participants	38 years STANDARD_DEVIATION 16 • n=5 Participants	35.73 years STANDARD_DEVIATION 9.93 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	13 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	13 Participants n=4 Participants
Race/Ethnicity, Customized Race · Caucasian	3 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants	15 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Race · European	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized Race · Mixed Race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 24 hours

The study aims to assess safety of the use of microprobe array continuous glucose sensor with regards to skin inflammation.

Outcome measures

Outcome measures
Measure	Microprobe Glucose Sensor Phase 1 n=8 Participants The microprobe array continuous glucose sensor applied to healthy volunteers for 6 h	Microprobe Glucose Sensor Phase 2 n=8 Participants The microprobe array continuous glucose sensor applied to healthy volunteers for 24 h	Microprobe Glucose Sensor Phase 3 n=10 Participants The microprobe array continuous glucose sensor applied to participants with type 1 diabetes
Number of Participant Developed the Skin Inflammation	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Only for Phase 3 arm

Phase 3 of the study aim to assess efficacy of the device in people with type 1 diabetes. This will be done in comparison to venous blood glucose using YSI machine in a controlled environment over 24 hours (phase 3). it was originally planned to then compare this to ISF glucose in ambulatory situation over five days (phase 4) however phase 4 did not go ahead. Measured using mean absolute relative difference with respect to venous blood glucose

Outcome measures

Outcome measures
Measure	Microprobe Glucose Sensor Phase 1 The microprobe array continuous glucose sensor applied to healthy volunteers for 6 h	Microprobe Glucose Sensor Phase 2 The microprobe array continuous glucose sensor applied to healthy volunteers for 24 h	Microprobe Glucose Sensor Phase 3 n=10 Participants The microprobe array continuous glucose sensor applied to participants with type 1 diabetes
Difference to the Venous Blood Glucose MARD	—	—	4 percentage

SECONDARY outcome

Timeframe: 24 hours

Population: Data not collected

The study aims to assess safety of the device with regards to pain degree in comparison to venflon insertion and insertion of an existing continuous glucose monitor (Medtronic iPro2 CGM system, Northridge, California). This will be done at each phase of the four study phases.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

This done using Optical Coherence Tomography and Confocal Microscopy. Measure = variation in penetration depth of microprobe needles over 24 hours

Outcome measures

Outcome measures
Measure	Microprobe Glucose Sensor Phase 1 n=8 Participants The microprobe array continuous glucose sensor applied to healthy volunteers for 6 h	Microprobe Glucose Sensor Phase 2 n=8 Participants The microprobe array continuous glucose sensor applied to healthy volunteers for 24 h	Microprobe Glucose Sensor Phase 3 n=10 Participants The microprobe array continuous glucose sensor applied to participants with type 1 diabetes
Number of Participant Developed Skin Penetration	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 hours

Population: Data not collected

This is a secondary outcome for phases 1 \& 2.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Population: Data not collected

This is a secondary outcome for phases 1 and 2. It is a primary outcome for phase 3. Using MARD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Population: Data not collected

This is a secondary outcome for phases 3 and 4.

Outcome measures

Outcome data not reported

Adverse Events

Microprobe Glucose Sensor Phase 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Microprobe Glucose Sensor Phase 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Microprobe Glucose Sensor Phase 3

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

Prof Nick Oliver

Imperial College London

Phone: 07957163617

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place