Last reviewed · How we verify

NCT03832907

Dexcom G6 Observational Study

Completed NA Results posted Last updated 5 August 2021
What this trial tests

NA trial testing Dexcom G6 CGM - Continues Glucose Monitoring sensor system in Diabetes in 101 participants. Completed in 31 March 2020.

Timeline
21 February 2019
Primary endpoint
31 March 2020
31 March 2020

Quick facts

Lead sponsorEmory University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment101
Start date21 February 2019
Primary completion31 March 2020
Estimated completion31 March 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Emory University

Who can join

18 and older, any sex, with 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.

Mean Daily Blood Glucose by POC Reading сompared to CGM Reading Primary · During hospital stay (3 days - up to 30 days)

Mean daily blood glucose will be calculated

POC
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System175.55± 42.37
CGM
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System175.84± 42.35
Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading Primary · During hospital stay (3 days - up to 30 days)

Number of clinical significant hypoglycemia (\<54 mg/dl) events will be calculated

POC
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System9
CGM
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System60
Number of Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading Primary · During hospital stay (3 days - up to 30 days)

Number of severe hyperglycemia (\>240 mg/dl) events will be recorded

POC
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System305
CGM
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System518
Mean Daily Blood Glucose by POC Reading Compared to CGM Reading Secondary · 10 days post discharge

Mean daily blood glucose will be calculated

POC
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System175.55± 42.37
CGM
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System173.13± 41.77
Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading Secondary · 10 days post discharge

Number of clinical significant hypoglycemia (\<54 mg/dl) events will be calculated

POC
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System9
CGM (arm)
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System29
Number of Clinical Significant Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading Secondary · 10 days post discharge

Number of severe hyperglycemia (\>240 mg/dl) events will be recorded

POC
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System305
CGM
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System399
Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading Secondary · During hospital stay (3 days - up to 30 days)

Number of nocturnal hypoglycemic events \< 70 mg/dl (between 22:00 and 06:00) will be recorded

POC
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System1
CGM abdomen
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System48
CGM arm
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System34
Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading Secondary · 10 days post discharge

Number of nocturnal hypoglycemic events \< 70 mg/dl(between 22:00 and 06:00) will be recorded

POC
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System1
CGM abdomen
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System22
CGM arm
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System9
Number of of Hypoglycemic Events < 70mg/dl in POC Group by POC Reading Compared to CGM Reading Secondary · During hospital stay (3 days - up to 30 days)

Number of of hypoglycemic events \< 70mg/dl will be recorded

POC
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System36
CGM abdomen
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System144
CGM arm
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System115
Number of Hypoglycemic Events < 70mg/dl by POC Reading Compared to CGM Reading Secondary · 10 days post discharge

Number of of hypoglycemic events \< 70mg/dl will be recorded

POC
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System10
CGM abdomen
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System100
CGM arm
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System48
Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading Secondary · During hospital stay (3 days - up to 30 days)

Time in hypoglycemia (minutes) during the day and night will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .

CGM abdomen)
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System119.08± 216.56
CGM arm
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System78.63± 135.33
Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading Secondary · 10 days post discharge

Time in hypoglycemia (minutes) during the day and night will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .

CGM abdomen
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System118.70± 217.83
CGM arm
GroupValue95% CI
Dexcom G6 CGM - Continues Glucose Monitoring Sensor System89.14± 140.16

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 month. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Serious: 0/101 (0%)
Deaths: 0/101
Other adverse events (1 terms — click to expand)

ReactionSystemDexcom G6 CGM - Continues …
Sensor site irritation/bleedingInjury, poisoning and procedural complications

Data from ClinicalTrials.gov NCT03832907 adverse events section.

Sponsor's own description

This is an exploratory prospective study primary aiming to evaluate differences between Point-of-care (POC) testing (standard of care) and Dexcom G6 CGM (Continues Glucose Monitoring sensor system) in 1) glycemic control measured by mean daily blood glucose and 2) identifying hypoglycemic and hyperglycemic events - in patients with type 1 and type 2 diabetes treated with basal bolus insulin regimen.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Accuracy of Dexcom G6 Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients With Diabetes.
    Davis GM, Spanakis EK, Migdal AL, Singh LG, et al · · 2021 · cited 102× · PMID 34099515 · DOI 10.2337/dc20-2856
  2. Remote Continuous Glucose Monitoring With a Computerized Insulin Infusion Protocol for Critically Ill Patients in a COVID-19 Medical ICU: Proof of Concept.
    Davis GM, Faulds E, Walker T, Vigliotti D, et al · · 2021 · cited 79× · PMID 33563655 · DOI 10.2337/dc20-2085
  3. Diabetes Technology in the Inpatient Setting for Management of Hyperglycemia.
    Davis GM, Galindo RJ, Migdal AL, Umpierrez GE. · · 2020 · cited 40× · PMID 31980123 · DOI 10.1016/j.ecl.2019.11.002
  4. A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient Management of Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial.
    Pasquel FJ, Lansang MC, Khowaja A, Urrutia MA, et al · · 2020 · cited 24× · PMID 32273271 · DOI 10.2337/dc19-1940

Verify or expand the search:

Other trials of Dexcom G6 CGM - Continues Glucose Monitoring sensor system

Trials testing the same drug.

Other recruiting trials for Diabetes

Currently open trials in the same condition.

Other Emory University 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/NCT03832907.

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