Dexcom G6 Intervention Study

Not Applicable

Completed

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

• Registration Number: NCT03877068
• Lead Sponsor: Emory University

Brief Summary

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).

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-15
• Study Start: 2019-06-26
• Primary Completion: 2021-02-27
• Study Completion: 2021-02-27
• Results First Submitted: 2022-03-25
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-21
• Last Update Submitted: 2023-10-21
• Results First Posted: 2023-10-24
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexcom G6 CGM - Continues Glucose Monitoring sensor system	Dexcom G6 CGM - Continues Glucose Monitoring sensor system	Patients will wear a real-time Dexcom G6 CGM, which provide BG readings every 5 minutes for up to 10 days. In addition, patients will undergo POC testing before meals and bedtime per hospital protocol. Insulin therapy will be titrated based on daily CGM printouts, which will include BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Patients will wear a CGM in the current approved insertion site, the abdomen, and in the upper arm.
Dexcom G6 CGM - Continues Glucose Monitoring sensor system	POC BG - Point-of-Care Blood Glucose monitoring	Patients will wear a real-time Dexcom G6 CGM, which provide BG readings every 5 minutes for up to 10 days. In addition, patients will undergo POC testing before meals and bedtime per hospital protocol. Insulin therapy will be titrated based on daily CGM printouts, which will include BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Patients will wear a CGM in the current approved insertion site, the abdomen, and in the upper arm.
POC BG - Point-of-Care Blood Glucose monitoring	POC BG - Point-of-Care Blood Glucose monitoring	Glucose monitoring by POC testing will be performed before meals and at bedtime. Results will be uploaded in the electronic medical record (EMR) system. The research team together with the PCP team will adjust daily insulin orders based on POC readings (standard of care). In addition, patients will wear a 'blinded' CGM where no results will be visualized by patients, nursing staff, primary care physician (PCP) or research teams.

Primary Outcome Measures

Name	Time	Method
Mean Daily Blood Glucose (BG) Concentration While Hospitalized	During hospitalization (up to 10 days)	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.
Percent of Time With BG Between 70-180 mg/dL While Hospitalized	During hospitalization (up to 10 days)	Glycemic control is measured by the percent of time with BG in the range of 70-180 mg/dL.
Number of Clinically Significant Hypoglycemia Events While Hospitalized	During hospitalization (up to 10 days)	The mean number of clinically significant hypoglycemia events, defined as BG \<54 mg/dl (3.0mmol/L), per participant is presented here.

Secondary Outcome Measures

Name	Time	Method
Percent of Time With Hyperglycemia While Hospitalized	During hospitalization (up to 10 days)	The percentage of time above the desired BG range, during the day and night while hospitalized was assessed.
Number of Hypoglycemia Events While Hospitalized	During hospitalization (up to 10 days)	The mean number of hypoglycemia events, defined as BG \< 70 (\<3.9 mmol/L), per participant during hospitalization is presented here.
Differences in BG by CGM Devices Placed in the Abdomen and Upper Extremity While Hospitalized	During hospitalization (up to 10 days)	The mean absolute relative difference (MARD) reflects accuracy of the CGM glucose reading compared to the reference POC reading. This is the current standard for assessing accuracy of glucometer readings. Lower MARD indicates smaller differences between the CGM and meter value; a higher MARD value indicates larger differences. A three way and direct head-to-head comparison of data from the abdomen, upper arm and POC BG will be compared.
Number of Clinically Significant Hypoglycemia Events After Discharge	After hospital discharge (up to 10 days)	The mean number of clinically significant hypoglycemia events, defined as BG \<54 mg/dl (3.0mmol/L), during the day and night after hospital discharge, per participant is presented here.
Number of Hypoglycemia Events After Discharge	After hospital discharge (up to 10 days)	The mean number of hypoglycemia events, defined as BG \< 70 (\<3.9 mmol/L), per participant after hospital discharge is presented here.
Number of Nocturnal Hypoglycemia Events While Hospitalized	During hospitalization (up to 10 days)	The mean number of events of nocturnal hypoglycemia per participant are presented here. Nocturnal hypoglycemia occurs between the hours of 12:00 midnight and 6:00 ante meridiem (AM). Hypoglycemia is defined as BG \< 70 mg/dL (\<3.9 mmol/L) and severe hypoglycemia is defined as BG \< 54 mg/dL (\<3.0 mmol/L).
Percent of Time With BG Between 70-180 mg/dL After Discharge	After hospital discharge (up to 10 days)	Glycemic control after hospital discharge is measured by the percent of time with BG in the range of 70-180 mg/dL.
Percent of Time With Hypoglycemia While Hospitalized	During hospitalization (up to 10 days)	The percentage of time spent with BG below the desired range, during the day and night of hospitalization was assessed. Hypoglycemia is defined as BG \< 70 mg/dL (\<3.9 mmol/L) and severe hypoglycemia is defined as BG \< 54 mg/dL (\<3.0 mmol/L).
Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) While Hospitalized	During hospitalization (up to 10 days)	Mean amplitude of glycemic excursions (MAGE), together with mean and standard deviation, is the parameter for assessing glycemic variability and is calculated based on the arithmetic mean of differences between consecutive peaks and nadirs of differences greater than one standard deviation of mean glycemia. It is designed to assess major glucose swings and exclude minor ones.
Number of Sensor Changes During Hospitalization	During hospitalization (up to 10 days)	Events related to sensor changes (blinded sensor for the POC group or real-time sensor for CGM group), such as removal for procedures or imaging, sensors failures, and sensors dislodgments were recorded.
Mean Daily BG Concentration After Discharge	After hospital discharge (up to 10 days)	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.
Count of Participants With Hypoglycemia After Discharge	After hospital discharge (up to 10 days)	Hypoglycemia is defined as BG \< 70 mg/dL (\<3.9 mmol/L) and severe hypoglycemia is defined as BG \< 54 mg/dL (\<3.0 mmol/L).
Percent of Time With Hyperglycemia After Discharge	After hospital discharge (up to 10 days)	The percentage of time above the desired BG range, during the day and night after hospital discharge was assessed.
Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) After Discharge	After hospital discharge (up to 10 days)	Mean amplitude of glycemic excursions (MAGE), together with mean and standard deviation, is the parameter for assessing glycemic variability and is calculated based on the arithmetic mean of differences between consecutive peaks and nadirs of differences greater than one standard of mean glycemia. It is designed to assess major glucose swings and exclude minor ones

Trial Locations

Locations (3)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Grady Health System; 🇺🇸 Atlanta, Georgia, United States

Univeristy of Maryland; 🇺🇸 Baltimore, Maryland, United States