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Trial Outcomes & Findings for FreeStyle Libre in Pregnancy Study (NCT NCT02665455)

NCT ID: NCT02665455

Last Updated: 2017-12-05

Results Overview

Point accuracy of Sensor based glucose values versus fingerstick blood glucose determined as % within Consensus Error Grid zone A. Zone A is defined as the zone of "clinical accurate measurements with no effect on clinical action."

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

83 participants

Primary outcome timeframe

14 days

Results posted on

2017-12-05

Participant Flow

Eighty-three (83) participants were consented. Nine of the 83 participants withdrew from the study on or before Visit 1 and before the device was worn or used. All 74 participants that wore a sensor are included in the analysis.

Participant milestones

Participant milestones
Measure
Intervention
FreeStyle Libre Flash Glucose Monitoring System FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days. During these 14 days subjects will be asked to perform 4 blood glucose tests (pre-meals and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed.
Overall Study
STARTED
83
Overall Study
COMPLETED
74
Overall Study
NOT COMPLETED
9

Reasons for withdrawal

Reasons for withdrawal
Measure
Intervention
FreeStyle Libre Flash Glucose Monitoring System FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days. During these 14 days subjects will be asked to perform 4 blood glucose tests (pre-meals and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed.
Overall Study
Withdrawal by Subject
6
Overall Study
Lost to Follow-up
1
Overall Study
Adverse Event
1
Overall Study
Protocol Violation
1

Baseline Characteristics

FreeStyle Libre in Pregnancy Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention
n=83 Participants
FreeStyle Libre Flash Glucose Monitoring System FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days. During these 14 days subjects will be asked to perform 4 blood glucose tests (pre-meals and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
83 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
83 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Point accuracy of Sensor based glucose values versus fingerstick blood glucose determined as % within Consensus Error Grid zone A. Zone A is defined as the zone of "clinical accurate measurements with no effect on clinical action."

Outcome measures

Outcome measures
Measure
Intervention
n=74 Participants
FreeStyle Libre Flash Glucose Monitoring System FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days. During these 14 days subjects will be asked to perform 4 blood glucose tests (pre-meals and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed.
Point Accuracy Determined as % Within Consensus Error Grid Zone A
88.1 percentage of results
Interval 86.0 to 89.6

Adverse Events

Intervention

Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Intervention
n=83 participants at risk
FreeStyle Libre Flash Glucose Monitoring System FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days. During these 14 days subjects will be asked to perform 4 blood glucose tests (pre-meals and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed.
Pregnancy, puerperium and perinatal conditions
Pre eclampsia
2.4%
2/83 • Number of events 2
Gastrointestinal disorders
Vomiting & epigastric pain
1.2%
1/83 • Number of events 1
Pregnancy, puerperium and perinatal conditions
Decreased foetal movements
1.2%
1/83 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Jolyon Bugler, Snr Director Clinical Development & Regulatory Affairs

Abbott Diabetes Care

Phone: +44 1993 863094

Results disclosure agreements

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

Restriction type: GT60