Recruiting

Dexcom G7 vs. POC

Sponsor:

Emory University

Code:

NCT06752928

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dexcom G7 rtCGM

Capillary Blood glucose Testing (POC)

Study Details

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

Study ID

NCT06752928

Start date

May 12, 2025

Status verified date

Jul, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Standard of Care

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.

experimental: Dexcom CGM

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.

Interventions

Dexcom G7 rtCGM

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

Capillary Blood glucose Testing (POC)

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

Primary outcome measure

  • Glycemic control [ Time Frame: Through study completion (Day 10 or the length of admission) ]
  • Clinically significant hypoglycemia <54 mg/dl [ Time Frame: Through study completion (Day 10 or the length of admission) ]

Central Contacts and Locations

Central contacts

Guillermo Umpierrez, MD

404-778-1665geumpie@emory.edu

Locations

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Guillermo Umpierrez, MD

404-778-1665geumpie@emory.edu

More Information

Sponsor

Emory University

Last update posted

Oct 8, 2025

Last verified

Jul, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-10-08.