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NCT03966911

Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics

Completed NA Results posted Last updated 7 June 2021
What this trial tests

NA trial testing Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter in Type 1 Diabetes Mellitus in 335 participants. Completed in 13 May 2020.

Timeline
14 June 2019
Primary endpoint
13 May 2020
13 May 2020

Quick facts

Lead sponsorMedtronic MiniMed, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment335
Start date14 June 2019
Primary completion13 May 2020
Estimated completion13 May 2020
Sites15 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Medtronic MiniMed, Inc.

Who can join

Adults 2 to 80, any sex, with Type 1 Diabetes Mellitus or Type2 Diabetes Mellitus. 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.

Percentage of Readings Within 20% Agreement Primary · 7 days (170 hours)

Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™\*) reference value (within 20 mg/dL if sensor values \< 80 mg/dL), across all participants and all Frequent Sample Testing (FST) days. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI.

GroupValue95% CI
Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3) on the Arm88.0086.05 – 89.95
Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3) on the Abdomen87.9686.13 – 89.80
Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3) on the Arm84.5982.02 – 87.17
Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3) on the Buttock81.0577.58 – 84.53

Adverse events — posted to ClinicalTrials.gov

Time frame: Throughout the course of the study, up to 91 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3)
Serious: 2/169 (1%)
Deaths: 0/169
Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3)
Serious: 2/142 (1%)
Deaths: 0/142

Serious adverse events (4 terms)

ReactionSystemAdult Subjects (Age 18-80)…Pediatric Subjects (Age 2-…
ProstatomegalyReproductive system and breast disorders——
HypoglycaemiaMetabolism and nutrition disorders——
Diabetic ketoacidosisMetabolism and nutrition disorders——
HyperglycaemiaMetabolism and nutrition disorders——
Other adverse events (46 terms — click to expand)

ReactionSystemAdult Subjects (Age 18-80)…Pediatric Subjects (Age 2-…
NasopharyngitisInfections and infestations——
HeadacheNervous system disorders——
HyperglycaemiaMetabolism and nutrition disorders——
Medical device site haemorrhageGeneral disorders——
Upper respiratory tract infectionInfections and infestations——
SyncopeNervous system disorders——
Dermatitis contactSkin and subcutaneous tissue disorders——
Gastroenteritis viralInfections and infestations——
Medical device site painGeneral disorders——
Road traffic accidentInjury, poisoning and procedural complications——
Viral upper respiratory tract infectionInfections and infestations——
VomitingGastrointestinal disorders——
ArthralgiaMusculoskeletal and connective tissue disorders——
Arthropod biteInjury, poisoning and procedural complications——
AsthmaRespiratory, thoracic and mediastinal disorders——
Attention deficit/hyperactivity disorderPsychiatric disorders——
Back painMusculoskeletal and connective tissue disorders——
ContusionInjury, poisoning and procedural complications——
Dermatitis allergicSkin and subcutaneous tissue disorders——
Ear infectionInfections and infestations——
EpistaxisRespiratory, thoracic and mediastinal disorders——
FolliculitisInfections and infestations——
Foot fractureInjury, poisoning and procedural complications——
Fungal skin infectionInfections and infestations——
GastroenteritisInfections and infestations——
Hot flushVascular disorders——
HypertriglyceridaemiaMetabolism and nutrition disorders——
InfluenzaInfections and infestations——
Infusion site painGeneral disorders——
Insulin resistanceMetabolism and nutrition disorders——
Medical device site bruiseGeneral disorders——
Medical device site infectionInfections and infestations——
Muscle strainInjury, poisoning and procedural complications——
NauseaGastrointestinal disorders——
NephrolithiasisRenal and urinary disorders——
Oral herpesInfections and infestations——
PharyngitisInfections and infestations——
Pharyngitis streptococcalInfections and infestations——
PneumoniaInfections and infestations——
PresyncopeNervous system disorders——

Most-reported serious reactions: Prostatomegaly, Hypoglycaemia, Diabetic ketoacidosis, Hyperglycaemia.

Data from ClinicalTrials.gov NCT03966911 adverse events section.

Sponsor's own description

The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).

Publications & conference data

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

Verify or expand the search:

Other recruiting trials for Type 1 Diabetes Mellitus

Currently open trials in the same condition.

Other Medtronic MiniMed, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03966911.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing