Dexcom G6 Intervention Study

NCT03877068 | Completed Results DMC FDA Device

• 1 other identifier: IRB00107703
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 3

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).

Conditions

Diabetes Mellitus

Keywords

Glycemic control; Bedside point-of-care capillary glucose monitoring; Dexcom; Continuous glucose monitoring; Hyperglycemia; Inpatient

Outcome Measures

Primary Outcomes (3)

• 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.

  During hospitalization (up to 10 days)

• Percent of Time With BG Between 70-180 mg/dL While Hospitalized

  Glycemic control is measured by the percent of time with BG in the range of 70-180 mg/dL.

  During hospitalization (up to 10 days)

• Number of Clinically Significant Hypoglycemia Events While Hospitalized

  The mean number of clinically significant hypoglycemia events, defined as BG \<54 mg/dl (3.0mmol/L), per participant is presented here.

  During hospitalization (up to 10 days)

Secondary Outcomes (14)

• Number of Hypoglycemia Events While Hospitalized

  During hospitalization (up to 10 days)

• Number of Nocturnal Hypoglycemia Events While Hospitalized

  During hospitalization (up to 10 days)

• Percent of Time With Hypoglycemia While Hospitalized

  During hospitalization (up to 10 days)

• Percent of Time With Hyperglycemia While Hospitalized

  During hospitalization (up to 10 days)

• Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) While Hospitalized

  During hospitalization (up to 10 days)

Study Arms (2)

Dexcom G6 CGM - Continues Glucose Monitoring sensor system

EXPERIMENTAL

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.

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

POC BG - Point-of-Care Blood Glucose monitoring

ACTIVE COMPARATOR

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.

Diagnostic Test: POC BG - Point-of-Care Blood Glucose monitoring

Interventions

Dexcom G6 CGM - Continues Glucose Monitoring sensor system 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 up to 10 days using the Dexcom Studio software to download the Dexcom receiver data.

Dexcom G6 CGM - Continues Glucose Monitoring sensor system

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

Also known as: Standard of Care capillary glucose test

Dexcom G6 CGM - Continues Glucose Monitoring sensor system; POC BG - Point-of-Care Blood Glucose monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥ 18 years admitted to a general medicine or surgical services.
• History of T1D or T2D receiving insulin therapy during hospital admission.
• 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).
• Patients with expected hospital length-of-stay of 2 or more day

You may not qualify if:

• Patients with acute illness admitted to the ICU or expected to require admission to the ICU.
• Patients expected to require MRI procedures during hospitalization.
• Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, end-stage renal disease (dialysis), or anasarca (massive peripheral edema).
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• Female subjects who are pregnant or breast-feeding at time of enrollment into the study.
• Coronavirus Disease 2019 (COVID-19) infection

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Grady Health System

Atlanta, Georgia, 30322, United States

Location

Univeristy of Maryland

Baltimore, Maryland, 21201, United States

Location

Related Publications (2)

• 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.

  PMID: 35984478 DERIVED

• 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.

  PMID: 32398351 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Guillermo E. Umpierrez, MD
• Organization: Emory University

geumpie@emory.edu

404-778-1665

Study Officials

• Guillermo Umpierrez, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 15, 2019
• Study Start: June 26, 2019
• Primary Completion: February 27, 2021
• Study Completion: February 27, 2021
• Last Updated: October 24, 2023
• Results First Posted: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available for sharing beginning 6 months after publication and ending 5 years after publication.
• Access Criteria: Individual participant data will be made available for sharing with researchers who provide a methodologically sound proposals should email proposals to geumpie@emory.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (3)