A Study Comparing Dexcom Continuous Glucose Monitoring to Point of Care Glucose Testing for the Management of Hospital and Post-Discharge Subjects With Type 1 Diabetes

NCT06752928 | Recruiting DMC FDA Device

• 1 other identifier: STUDY00008724
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare inpatient glycemic control by measuring the percentage of time in the range of 70-180 mg/dl and the frequency of hypoglycemia between Dexcom G7 Continuous Glucose Monitoring (CGM) and Point of Care (POC) Blood Glucose Testing in poorly controlled subjects with Type 1 Diabetes Mellitus. The main question it aims to answer is:

• Whether there is a difference between POC testing (standard of care) and Real-time CGM in glycemic control and hypoglycemic events during hospitalization:

Conditions

Type 1 Diabetes

Keywords

Continuous Glucose Monitoring; Type 1 Diabetes Mellitus; Point of Care

Outcome Measures

Primary Outcomes (2)

• Glycemic control

  The total difference in blood sugar levels between the POC testing (standard of care) group and the rtCGM group throughout the hospitalization

  Through study completion (Day 10 or the length of admission)

• Clinically significant hypoglycemia <54 mg/dl

  The difference between blood sugar levels in POC testing (standard of care) group and rtCGM group during hospitalization

  Through study completion (Day 10 or the length of admission)

Secondary Outcomes (10)

• Time above range

  Through study completion (Day 10 or the length of admission)

• Time below range

  Through study completion (Day 10 or the length of admission)

• Glycemic Variability [% Coefficient of Variation (%CV)

  Through study completion (Day 10 or the length of admission)

• Hypoglycemic events

  Through study completion (Day 10 or the length of admission)

• Hyperglycemic events

  Through study completion (Day 10 or the length of admission)

Other Outcomes (1)

• Clinically significant hypoglycemia

  Through study completion (Day 10 or the length of admission)

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Severe hyperglycemia will be managed by primary care professionals (Hospitalist Service) with intravenous or subcutaneous insulin therapy. Subjects will be invited to participate in the study after the resolution of severe hyperglycemia (BG \< 400 mg/dl). Glucose monitoring by POC testing will be performed before meals and at bedtime. Results will be uploaded to the electronic medical record (EMR) system. The research team, together with the Primary care (PCP) team, will adjust daily insulin orders based on POC readings (standard of care). In addition, subjects will wear a 'blinded' CGM (no results will be visualized by patients, nursing staff, medicine, or research teams) during hospitalization for up to 10 days.

Diagnostic Test: Capillary Blood glucose Testing (POC)

Dexcom CGM

EXPERIMENTAL

Severe hyperglycemia will be managed by primary care professionals (Hospitalist Service) intravenously with subcutaneous insulin therapy. Subjects will be invited to participate in the study after the resolution of severe hyperglycemia (BG \< 400 mg/dl). Subjects will wear a real-time Dexcom G7 CGM for up to 10 days. Insulin therapy will be titrated based on daily CGM reports, including mean glucose, glycemic excursions, hypoglycemia, and severe hyperglycemia \> 180 and \>250 mg/dl values. Participants will wear a Dexcom rtCGM for up to 10 days during hospitalization.

Device: Dexcom G7 rtCGM

Interventions

Dexcom G7 rtCGM DEVICE

The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 CGM System or G7) is a glucose monitoring system that continuously measures glucose in the interstitial fluid. It aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments

Dexcom CGM

Capillary Blood glucose Testing (POC) DIAGNOSTIC_TEST

POC glucose meters measure whole blood and convert the results to plasma glucose concentrations, which is the standardized form used in clinical practice.

Also known as: POCT (point of care therapy)

Standard of Care

Eligibility Criteria

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

You may qualify if:

• Known history of T1D treated with insulin therapy (human regular or rapid-acting analogs or ultra-rapid analogs \[lispro, aspart, glulisine, fast-acting insulin aspart, insulin lispro\]), intermediate-acting (NPH and premixed formulations) or long-acting basal (glargine, detemir, degludec) formulations.
• Admission diagnosis of T1D with poorly controlled diabetes (blood glucose \> 180 mg/dl, HbA1c \> 7%), including diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar state (HHS).
• Expected length of hospital stay \> three days at the time of randomization

You may not qualify if:

• Patients admitted to the ICU
• Subjects using CGM technology before admission
• Subjects with type 2 diabetes
• Treatment with systemic immunosuppressive agents
• Cystic fibrosis
• Prisoners
• Patients expected to require MRI procedures during hospitalization.
• Female subjects who are pregnant or breastfeeding at enrollment into the study.
• Subjects not willing to wear a CGM device
• Subjects with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension) and end-stage kidney disease (eGFR\< 30 ml/min), or terminal illness.
• Subjects with a history of cognitive impairment, dementia, or mental condition rendering the subject unable to understand the nature and consequences of the study

Sponsors & Collaborators

• Emory University: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Guillermo Umpierrez, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillermo Umpierrez, MD

CONTACT

404-778-1665; geumpie@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Research design Adult subjects with T1D admitted to non-ICU medicine and surgery units and receiving insulin therapy will be randomized to either standard POC testing or Dexcom G7 CGM to guide insulin dose adjustments, with the POC group wearing a blinded CGM and the CGM group having insulin adjustments based on daily glucose profiles.

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 31, 2024
• Study Start: May 12, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)