Trial Outcomes & Findings for Navigator II Continuous Glucose Monitor Home Use Study (NCT NCT01455064)

Last Updated: 2013-07-22

Results Overview

Percentage of CGM results in the clinically accurate Zone A and percentage of CGM results in the clinically acceptable Zones A and B of the Clarke Error Grid versus blood glucose reference.

Recruitment status

COMPLETED

Target enrollment

31 participants

Primary outcome timeframe

15 days sensor wear

Results posted on

2013-07-22

Participant Flow

Participants were recruited from within the patient population of two US diabetes clinical centers.

Participant milestones

Participant milestones
Measure	Observational Group Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
Overall Study STARTED	31
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Navigator II Continuous Glucose Monitor Home Use Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Observational Group n=31 Participants Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
Age, Customized	48.4 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Weight	90.4 kilograms n=5 Participants
Height	1.70 meters n=5 Participants
Years since diagnosis	19.6 years n=5 Participants
Daily total insulin dosage	72.8 units n=5 Participants
Total number of injections per day	3.6 injections (N subjects = 18) n=5 Participants

PRIMARY outcome

Timeframe: 15 days sensor wear

Population: One subject was withdrawn due to a mild reaction to the sensor adhesive. This subject's data was included in the study up to the point of withdrawal.

Percentage of CGM results in the clinically accurate Zone A and percentage of CGM results in the clinically acceptable Zones A and B of the Clarke Error Grid versus blood glucose reference.

Outcome measures

Outcome measures
Measure	Observational Group n=2843 Results Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
Clarke Error Grid Analysis Percentage of results in Clarke Error Zone A	83.0 Percentage of Results
Clarke Error Grid Analysis Percentage_Results in Clarke Error Zones A&B	97.7 Percentage of Results

Adverse Events

Observational Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Observational Group n=31 participants at risk Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
Endocrine disorders Severe hypoglycemia	3.2% 1/31 • Number of events 1
Skin and subcutaneous tissue disorders Scabbing	6.5% 2/31 • Number of events 2
Skin and subcutaneous tissue disorders Pruritus	3.2% 1/31 • Number of events 1
Skin and subcutaneous tissue disorders Erythema	3.2% 1/31 • Number of events 1
General disorders Laryngitis	3.2% 1/31 • Number of events 1
Infections and infestations Ear infection in right ear	3.2% 1/31 • Number of events 1

Additional Information

Shridhara A. Karinka, Ph.D., Director of Clinical Affairs

Abbott Diabetes Care

Phone: 510-749-6393

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60