Trial Outcomes & Findings for CGM Precision and Glycaemic Variability (NCT NCT03842683)

NCT ID: NCT03842683

Last Updated: 2019-11-20

Results Overview

Continuous glucose monitoring (CGM) measurements are delayed compared to blood glucose. The CGM signal is time-shifted -1 minute at a time and the mean absolute difference between CGM and blood glucose measurements are calculated at each step. The lowest mean absolute difference depicts the optimal time shift in minutes. The resultant mean absolute relative difference is provided as outcome. Publication reference: https://doi.org/10.1177/1932296819848721

• Recruitment status: COMPLETED
• Target enrollment: 472 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2019-11-20

Participant Flow

Participant milestones

Measure	Continuous Glucose Monitoring Users User of continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII)
Overall Study STARTED	472
Overall Study COMPLETED	472
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	CGM Users n=472 Participants User of CGM and CSII
Age, Continuous	44 years STANDARD_DEVIATION 15 • n=472 Participants
Sex: Female, Male Female	203 Participants n=472 Participants
Sex: Female, Male Male	269 Participants n=472 Participants
BMI	26 kg/m^2 STANDARD_DEVIATION 4 • n=472 Participants
HbA1c	7.5 % of glycated hemoglobin STANDARD_DEVIATION 0.5 • n=472 Participants

PRIMARY outcome

Timeframe: 16 weeks

Continuous glucose monitoring (CGM) measurements are delayed compared to blood glucose. The CGM signal is time-shifted -1 minute at a time and the mean absolute difference between CGM and blood glucose measurements are calculated at each step. The lowest mean absolute difference depicts the optimal time shift in minutes. The resultant mean absolute relative difference is provided as outcome.

Publication reference: https://doi.org/10.1177/1932296819848721

Outcome measures

Measure	CGM Users n=472 Participants User of CGM and CSII
Optimal Time Shift of Continuous Glucose Monitoring Measurements	1.01 Percentage point change in MARD Interval 0.77 to 1.25

SECONDARY outcome

Timeframe: 16 weeks

Population: Nine people from the original study did not have sufficient CGM, insulin, or meal data for the calculation of features.

Area under the receiver operating characteristics curve (ROC-AUC) is a measure of the prediction capabilities of a prediction algorithm. Each point of the curve gives a sensitivity and a specificity of the prediction.

Publication reference: https://doi.org/10.1177/1932296819868727

Outcome measures

Measure	CGM Users n=463 Participants User of CGM and CSII
Area Under the Receiver Operating Characteristics Curve of the Hypoglycemia Prediction	0.79 probability Interval 0.74 to 0.85

Adverse Events

CGM Users

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. Morten Hasselstrøm Jensen

Steno Diabetes Center North Denmark

Phone: +4522226964

Email: mhj@hst.aau.dk

Results disclosure agreements

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