Clinical trial NCT03877068: Dexcom G6 Intervention Study
Official title: Management of Inpatient Hyperglycemia by Continuous Glucose Monitoring in Insulin-treated Patients With Diabetes: Dexcom G6 Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Glycemic control
Bedside point-of-care capillary glucose monitoring
Dexcom
Continuous glucose monitoring
Hyperglycemia
Inpatient
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Daily Blood Glucose (BG) Concentration While Hospitalized
timeFrame: During hospitalization (up to 10 days)
measure: Percent of Time With BG Between 70-180 mg/dL While Hospitalized
timeFrame: During hospitalization (up to 10 days)
measure: Number of Clinically Significant Hypoglycemia Events While Hospitalized
timeFrame: During hospitalization (up to 10 days)
Secondary outcomes:
measure: Number of Hypoglycemia Events While Hospitalized
timeFrame: During hospitalization (up to 10 days)
measure: Number of Nocturnal Hypoglycemia Events While Hospitalized
timeFrame: During hospitalization (up to 10 days)
measure: Percent of Time With Hypoglycemia While Hospitalized
timeFrame: During hospitalization (up to 10 days)
measure: Percent of Time With Hyperglycemia While Hospitalized
timeFrame: During hospitalization (up to 10 days)
measure: Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) While Hospitalized
timeFrame: During hospitalization (up to 10 days)
measure: Differences in BG by CGM Devices Placed in the Abdomen and Upper Extremity While Hospitalized
timeFrame: During hospitalization (up to 10 days)
measure: Number of Sensor Changes During Hospitalization
timeFrame: During hospitalization (up to 10 days)
measure: Mean Daily BG Concentration After Discharge
timeFrame: After hospital discharge (up to 10 days)
measure: Percent of Time With BG Between 70-180 mg/dL After Discharge
timeFrame: After hospital discharge (up to 10 days)
measure: Number of Clinically Significant Hypoglycemia Events After Discharge
timeFrame: After hospital discharge (up to 10 days)
measure: Number of Hypoglycemia Events After Discharge
timeFrame: After hospital discharge (up to 10 days)
measure: Count of Participants With Hypoglycemia After Discharge
timeFrame: After hospital discharge (up to 10 days)
measure: Percent of Time With Hyperglycemia After Discharge
timeFrame: After hospital discharge (up to 10 days)
measure: Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) After Discharge
timeFrame: After hospital discharge (up to 10 days)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Baltimore
country: United States
facility: Univeristy of Maryland
state: Maryland
Study officials:
affiliation: Emory University
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spanakis EK, Urrutia A, Galindo RJ, Vellanki P, Migdal AL, Davis G, Fayfman M, Idrees T, Pasquel FJ, Coronado WZ, Albury B, Moreno E, Singh LG, Marcano I, Lizama S, Gothong C, Munir K, Chesney C, Maguire R, Scott WH, Perez-Guzman MC, Cardona S, Peng L, Umpierrez GE. Continuous Glucose Monitoring-Guided Insulin Administration in Hospitalized Patients With Diabetes: A Randomized Clinical Trial. Diabetes Care. 2022 Oct 1;45(10):2369-2375. doi: 10.2337/dc22-0716.
citation: Spanakis EK, Singh LG, Siddiqui T, Sorkin JD, Notas G, Magee MF, Fink JC, Zhan M, Umpierrez GE. Association of glucose variability at the last day of hospitalization with 30-day readmission in adults with diabetes. BMJ Open Diabetes Res Care. 2020 May;8(1):e000990. doi: 10.1136/bmjdrc-2019-000990.