Dexcom G6 Observational Study

NCT ID: NCT03832907

Last Updated: 2021-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-21
• Study Completion Date: 2020-03-31

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.

Detailed Description

Several studies have shown that the use of a device that can measure blood glucose levels every 5 minutes is more effective in identifying low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia) when compared to regular measurements with fingersticks [point of care (POC)].

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Dexcom G6 CGM - Continues Glucose Monitoring sensor system

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.

Group Type: EXPERIMENTAL

Dexcom G6 CGM - Continues Glucose Monitoring sensor system

Intervention Type: 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.

POC BG - Point-of-Care Blood Glucose monitoring

Intervention Type: 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.

Interventions

Dexcom G6 CGM - Continues Glucose Monitoring sensor system

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.

Intervention Type: DEVICE

POC BG - Point-of-Care Blood Glucose monitoring

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Standard of Care capillary glucose test

Eligibility Criteria

Inclusion Criteria

1. > 18 years admitted to a general medicine or surgical service.

2. Known history of T1D or T2D receiving insulin therapy

3. 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).

4. Patients with expected hospital length-of-stay of 3 or more days

Exclusion Criteria

1. Patients with acute illness admitted to the ICU or expected to require admission to the ICU.

2. Patients expected to require MRI procedures during hospitalization.

3. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

4. Female subjects who are pregnant or breast-feeding at time of enrollment into the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Umpierrez, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo Umpierrez, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00107627

Identifier Type: -

Identifier Source: org_study_id