NCT03832907

Dexcom G6 Observational Study

Inpatient and Post-hospital Discharge Assessment of Glycemic Control by Capillary Point-of-care Glucose Testing and by Continuous Glucose Monitoring in Insulin-treated Patients With Type 1 and Type 2 Diabetes: Dexcom G6 Observational Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2019-02-21
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2019-02-06
• Last updated: 2021-08-05
• Results posted: 2021-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study