Dexcom G6 Intervention Study

Emory University185 enrolled

Overview

The study will assess if Continuous Glucose Monitoring (CGM) represents a better tool to guide healthcare providers in adjusting insulin therapy, by providing a more complete 24-hour assessment of glucose values compared to Point of Care (POC) testing, during hospitalization and after hospital discharge in general medicine and surgery patients with Type 2 Diabetes (T2D) and Type 1 Diabetes (T1D).

Diabetes is reported in 20-34% of hospitalized adult patients in general medicine and surgery units and there is a large body of literature showing a strong association between diabetes and increased hospital mortality and morbidity. Clinical guidelines have recommended the use of basal bolus insulin regimens as the preferred management approach of non-intensive care unit (ICU) patients with diabetes, as it has been shown to be effective in improving glycemic control and reducing hospital complications. However, hypoglycemia is a common adverse event of insulin therapy, with incidence rates ranging between 12% and 35% in randomized studies in non-ICU settings. The development of hypoglycemia, like hyperglycemia, has been associated with higher rates of hospital complications, higher health care resource utilization, and hospital mortality. Bedside point-of-care (POC) capillary glucose monitoring is the standard of care to assess glycemic control in the hospital. Diabetes guidelines recommend bedside capillary POC testing before meals and at bedtime to assess glycemic control and to adjust insulin therapy in the hospital. In contrast to POC testing, continuous glucose monitoring (CGM) measures interstitial glucose every 5-15 minutes, thus providing a more complete glycemic profile during 24-hours compared to standard POC glucose testing. The study will assess if CGM represents a better tool to guide healthcare providers in adjusting insulin therapy by providing a more complete 24-hour assessment of glucose values compared to POC testing, during hospitalization and after hospital discharge in general medicine and surgery patients with T2D and T1D. Participants will be randomized to have the standard of care POC testing plus wear a sham CGM or to wear a real-time Dexcom G6 CGM, which provide BG readings every 5 minutes for up to 10 days during hospitalization. At the point of hospital discharge, participants with poorly controlled diabetes will be invited to participate in an open label outpatient study where they will wear a Dexcom G6 CGM or sham device for 10 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

185

Conditions

Diabetes Mellitus

Interventions

Dexcom G6 CGM - Continues Glucose Monitoring sensor systemDEVICE

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 up to 10 days using the Dexcom Studio software to download the Dexcom receiver data.

POC BG - Point-of-Care Blood Glucose monitoringDIAGNOSTIC_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 up to 10 days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Males and females ≥ 18 years admitted to a general medicine or surgical services. 2. History of T1D or T2D receiving insulin therapy during hospital admission. 3. Subjects must have a randomization BG \<400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate \< 18 milliequivalents per litre (mEq/L), potential of hydrogen (pH) \< 7.30, or positive serum or urinary ketones). 4. Patients with expected hospital length-of-stay of 2 or more day 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. Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, end-stage renal disease (dialysis), or anasarca (massive peripheral edema). 4. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 5. Female subjects who are pregnant or breast-feeding at time of enrollment into the study. 6. Coronavirus Disease 2019 (COVID-19) infection

Locations (3)

Emory University Hospital

Atlanta, Georgia, United States

Grady Health System

Atlanta, Georgia, United States

Univeristy of Maryland

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Mean Daily Blood Glucose (BG) Concentration While Hospitalized

A random (non-fasting) blood glucose measurement of 140 mg/dL or less is considered normal, while a measurement of 200 mg/dL or more indicates diabetes.