Dexcom G6 Observational Study

NCT03832907 | Completed Results DMC FDA Device

• 1 other identifier: IRB00107627
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes

Keywords

Glucose monitoring; POC BG; DexcomG6 CGM

Outcome Measures

Primary Outcomes (3)

• Mean Daily Blood Glucose by POC Reading сompared to CGM Reading

  Mean daily blood glucose will be calculated

  During hospital stay (3 days - up to 30 days)

• Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading

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

  During hospital stay (3 days - up to 30 days)

• Number of Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading

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

  During hospital stay (3 days - up to 30 days)

Secondary Outcomes (47)

• Mean Daily Blood Glucose by POC Reading Compared to CGM Reading

  10 days post discharge

• Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading

  10 days post discharge

• Number of Clinical Significant Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading

  10 days post discharge

• Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading

  During hospital stay (3 days - up to 30 days)

• Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading

  10 days post discharge

Study Arms (1)

Dexcom G6 CGM - Continues Glucose Monitoring sensor system

EXPERIMENTAL

The Dexcom G6 CGM is a commercially available factory-calibrated sensor system. The system measures interstitial glucose every 5-15 minutes, providing real-time and more complete glycemic profile during 24-hours compared to standard POC glucose testing, and replaces the need for finger sticking. Potential limitations include the need for removing the sensor before MRI or diathermy treatment, and the potential interference in patients with severe dehydration. In parallel, same participants will be monitored by the standard of care point-of-care (POC) capillary glucose tests. Diabetes guidelines recommend bedside capillary POC testing before meals and at bedtime to assess glycemic control and to adjust insulin therapy in the hospital.

Device: Dexcom G6 CGM - Continues Glucose Monitoring sensor system; Diagnostic Test: POC BG - Point-of-Care Blood Glucose monitoring

Interventions

Dexcom G6 CGM - Continues Glucose Monitoring sensor system DEVICE

A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.

Dexcom G6 CGM - Continues Glucose Monitoring sensor system

POC BG - Point-of-Care Blood Glucose monitoring DIAGNOSTIC_TEST

Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.

Also known as: Standard of Care capillary glucose test

Dexcom G6 CGM - Continues Glucose Monitoring sensor system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years admitted to a general medicine or surgical service.
• Known history of T1D or T2D receiving insulin therapy
• Subjects must have a randomization BG between 140 mg and 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate \< 18 mEq/L, pH \< 7.30, or positive serum or urinary ketones).
• Patients with expected hospital length-of-stay of 3 or more days

You may not qualify if:

• Patients with acute illness admitted to the ICU or expected to require admission to the ICU.
• Patients expected to require MRI procedures during hospitalization.
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• Female subjects who are pregnant or breast-feeding at time of enrollment into the study.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Umpierrez
• Organization: Emory University

geumpie@emory.edu

404-778-1665

Study Officials

• Guillermo Umpierrez, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 6, 2019
• Study Start: February 21, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: August 5, 2021
• Results First Posted: August 5, 2021

Record last verified: 2021-08

Locations

US (1)