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

Not Applicable

Not yet recruiting

• Conditions: Type 1 Diabetes

• Registration Number: NCT06752928
• Lead Sponsor: Emory University

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:

Detailed Description

The CDC reports that 1.6 million U.S. adults (5.7%) have type 1 diabetes (T1D), with hospitalization rates three times higher than the general population, primarily due to diabetes-related complications such as ketoacidosis and cardiovascular disease. A study at Emory University found that hospitalized T1D patients are younger, experience longer stays and more admissions, and face worse glycemic control and higher rates of hypoglycemia compared to type 2 diabetes (T2D) patients.

Point-of-care (POC) capillary glucose testing is the standard for monitoring hospitalized diabetes patients, but continuous glucose monitoring (CGM) offers more detailed glycemic profiles. Research, including trials using Dexcom CGM systems, has demonstrated CGM's superior ability to detect hypo- and hyperglycemia, reduce hypoglycemic events, and improve insulin therapy adjustments in T2D patients. However, no randomized controlled studies have evaluated the best glucose monitoring system for hospitalized T1D patients.

The proposed study aims to compare POC testing with Dexcom G7 CGM for guiding insulin therapy in hospitalized T1D patients. Researchers hypothesize that CGM will better prevent hypoglycemia and improve glycemic management during hospital stays, addressing a critical gap in evidence regarding glucose control's impact on T1D hospital outcomes.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Study Start: 2025-02
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glycemic control	Through study completion (Day 10 or the length of admission)	The total difference in blood sugar levels between the POC testing (standard of care) group and the rtCGM group throughout the hospitalization
Clinically significant hypoglycemia <54 mg/dl	Through study completion (Day 10 or the length of admission)	The difference between blood sugar levels in POC testing (standard of care) group and rtCGM group during hospitalization

Secondary Outcome Measures

Name	Time	Method
Time above range	Through study completion (Day 10 or the length of admission)	% time above Target Above range (TAR). Differences between the both groups will be calculated. (TAR, \>250 mg/dl)
Time below range	Through study completion (Day 10 or the length of admission)	% time in Below Target range (TBR). Differences between the both groups will be calculated.; Differences between the both groups will be calculated. (TBR, \< 70 and 54 mg/dl)
Glycemic Variability [% Coefficient of Variation (%CV)	Through study completion (Day 10 or the length of admission)	% coefficient of variation will be measured during the intervention phase, compared to control, as measured by CGM.
Hypoglycemic events	Through study completion (Day 10 or the length of admission)	Number of hypoglycemia events \< 70 and 54 mg/dl
Hyperglycemic events	Through study completion (Day 10 or the length of admission)	Number of hypoglycemia events \>250 mg/dl
Nocturnal hypoglycemia	Through study completion (Day 10 or the length of admission)	Number of hypoglycemic events (\<70 and \<54 mg/dl) between 22:00 and 06:00
Prolonged hypoglycemia	Through study completion (Day 10 or the length of admission)	Number of events of Prolonged hypoglycemia \< 70 mg/dl for more than 2 hours by CGM
Hospital Complications	Through study completion (Day 10 or the length of admission)	Hospital complications include a composite of acute kidney injury (doubling of serum creatinine \>0.5 mg/dl from baseline), cardiovascular events, infections, and death
Recurrent hypoglycemia	Through study completion (Day 10 or the length of admission)	Number of recurrent hypoglycemic episodes (\< 70 mg/dl)
Recurrent hyperglycemia	Through study completion (Day 10 or the length of admission)	Number of recurrent hyperglycemic episodes (\>250 mg/dl)

Trial Locations

Locations (1)

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States