NCT04020822

Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices

Completed NA Results posted Last updated 16 September 2020

What this trial tests

NA trial testing Guardian Sensor (3) in Type 1 Diabetes in 19 participants. Completed in 27 August 2019.

Timeline

29 July 2019

Primary endpoint
27 August 2019

27 August 2019

Quick facts

Lead sponsor	Medtronic MiniMed, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	19
Start date	29 July 2019
Primary completion	27 August 2019
Estimated completion	27 August 2019
Sites	2 locations across United States

Drugs / interventions tested

• Guardian Sensor (3)

Conditions studied

• Type 1 Diabetes — all drugs for Type 1 Diabetes →
• Type 2 Diabetes — all drugs for Type 2 Diabetes →

Sponsor

Medtronic MiniMed, Inc.

Who can join

Adults 18 to 75, any sex, with Type 1 Diabetes or Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Accuracy of Sensor Glucose Before and After Acetaminophen Administration Primary · Assessed up to 11 days, frequent sample testing recordings from the three-hour period leading to and after Acetaminophen ingestion on days 3, 5, and 6 reported

Accuracy (mean absolute relative difference) between the primary sensor values and meter BG values during the hour leading to and two hours after ingestion of acetaminophen. Primary sensor will be assigned to sensor number one (inserted in arm). Mean Absolute Relative Difference = Mean of ((absolute difference of meter and sensor blood glucose values / meter glucose values) \* 100). Note that the results reported below for one hour leading to and two hours after acetaminophen ingestion were pooled together across multiple testing days (days 3, 5, and 6).

(-1, 0] hour of Acetaminophen Ingestion

Group	Value	95% CI
Subjects Wearing Guardian Sensor (3)s	9.46	± 4.63

(0, 1] hour of Acetaminophen Ingestion

Group	Value	95% CI
Subjects Wearing Guardian Sensor (3)s	12.02	± 6.53

(1, 2] hour of Acetaminophen Ingestion

Group	Value	95% CI
Subjects Wearing Guardian Sensor (3)s	16.98	± 10.96

Sponsor's own description

The purpose of Phase 3 Group is to evaluate the impact of acetaminophen on the performance of Guardian Sensor (3) during 11 days of wear (approximately 264 hours) in subjects with insulin requiring diabetes,18-75 years of age.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.