Trial Outcomes & Findings for Use of the FreeStyle Navigator Continuous Glucose Monitoring System to Enhance Education and Glycaemic Control (NCT NCT01214824)

NCT ID: NCT01214824

Last Updated: 2013-07-02

Results Overview

HbA1c at baseline HbA1c at 6 months Change in HbA1c(%)(6 months - baseline)

Recruitment status

COMPLETED

Study phase

Target enrollment

32 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2013-07-02

Participant Flow

Participants with type 1 or type 2 diabetes on Multiple Daily Injection(MDI)of insulin(3 or more injections per day)with an HbA1c of 8% or more for their last two tests were recruited at five sites across the United Kingdom. The target enrolment was 50 subjects, with the aim of completing the study with 40 subjects for statistical analysis.

Participant milestones

Participant milestones
Measure	Intervention Group Participants using the FreeStyle Navigator System Intermittently. At the start and end of the study subjects wore the FreeStyle Navigator masked (without seeing continuous glucose results) for 5 days (1 sensor wear). During the study subjects used the FreeStyle Navigator fully functional (unmasked) for 2 periods. The first unmasked phase was for 2 weeks (3 sensor wears) following the baseline masked wear. The second unmasked phase was a 5 day wear at 3 months. After each unmasked phase the HCP reviewed results with the subject and changes to insulin regimen were recommended as required. For the remainder of the study a standard blood glucose meter was used for diabetes management.
Overall Study STARTED	32
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of the FreeStyle Navigator Continuous Glucose Monitoring System to Enhance Education and Glycaemic Control

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=32 Participants Participants using the FreeStyle Navigator System Intermittently
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	42.5 years n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Body Mass Index (BMI)	26.3 kg/m^2 n=5 Participants
Weight	73.7 Kg n=5 Participants
Years since diagnosis	17.6 Years n=5 Participants
Daily Total Insulin Dosage-Basal	24.9 Units n=5 Participants
Daily Total Insulin Dosage-Bolus	28.0 Units n=5 Participants
Number of injections per day	4.1 Injections n=5 Participants
Number of blood glucose measurements per day	4.5 Tests n=5 Participants
HbA1c	9.3 % n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Intention to treat analysis

HbA1c at baseline HbA1c at 6 months Change in HbA1c(%)(6 months - baseline)

Outcome measures

Outcome measures
Measure	Intervention Group n=32 Participants Participants using the FreeStyle Navigator System Intermittently
Change in HbA1C From Baseline to 6 Months Baseline	9.3 HbA1c % Standard Deviation 1.3 • Interval -0.8 to 0.0
Change in HbA1C From Baseline to 6 Months 6 months	9.1 HbA1c % Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Intention to treat analysis

Number of subjects with a HbA1c reduction greater than or equal to 0.5% and 95% confidence interval from visit 1 (baseline) to visit 7 (6 months).

Outcome measures

Outcome measures
Measure	Intervention Group n=32 Participants Participants using the FreeStyle Navigator System Intermittently
Number of Subjects Who Had Reduction in HbA1c of > or = 0.5%	14 participants

SECONDARY outcome

Timeframe: Baseline & 6 months

Population: Analysis per protocol

Proportion of time (hours per day) in hypoglycaemia (\<3.9 mmol/L) for the masked phase. There were two masked phases in the study, one 5 day wear at baseline and one 5 day wear at 6 months. During masked wear subject were not able to see continuous glucose data from the device.

Outcome measures

Outcome measures
Measure	Intervention Group n=28 Participants Participants using the FreeStyle Navigator System Intermittently
Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked Time in hypoglycaemia (<3.9mmol/L)-masked phase 1	0.93 Hours per day Standard Deviation 0.84
Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked Time in hypoglycaemia (<3.9mmol/L)-masked phase 2	1.06 Hours per day Standard Deviation 1.02

SECONDARY outcome

Timeframe: 2 weeks following baseline & 3 months

Population: Analysis per protocol 31 participants analysed in the unmasked phase 1 28 participants analysed in the unmasked phase 2

Proportion of time (hours per day) in hypoglycaemia (\<3.9mmol/L) for the unmasked phase

Outcome measures

Outcome measures
Measure	Intervention Group n=31 Participants Participants using the FreeStyle Navigator System Intermittently
Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked Time in hypoglycaemia(3.9mmol/L)unmasked phase 1	0.60 Hours per day Standard Deviation 0.47
Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked Time in hypoglycaemia(3.9mmol/L)unmasked phase 2	0.49 Hours per day Standard Deviation 0.55

Adverse Events

Intervention Group

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intervention Group n=32 participants at risk Participants using the FreeStyle Navigator System Intermittently
General disorders Right iliac fossa pain	3.1% 1/32 • Number of events 1
Skin and subcutaneous tissue disorders Unresolving Paronychia	3.1% 1/32 • Number of events 1
Infections and infestations Viral Meningitis	3.1% 1/32 • Number of events 1

Other adverse events

Other adverse events
Measure	Intervention Group n=32 participants at risk Participants using the FreeStyle Navigator System Intermittently
Infections and infestations Infection	3.1% 1/32 • Number of events 1
Musculoskeletal and connective tissue disorders Abdominal pain (muscle strain)	3.1% 1/32 • Number of events 1
Musculoskeletal and connective tissue disorders Broken toe	3.1% 1/32 • Number of events 1

Additional Information

Director Global Clinical and EMEA Regulatory Affairs

Abbott Diabetes Care

Phone: 01993863164

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60