Clinical trial NCT06752928: 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
Official title: A Randomized Controlled Trial Comparing Dexcom Continuous Glucose Monitoring to Point of Care Glucose Testing for the Management of Hospital and Post-Discharge Subjects with Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Continuous Glucose Monitoring
Type 1 Diabetes Mellitus
Point of Care
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2024-12-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic control
timeFrame: Through study completion (Day 10 or the length of admission)
measure: Clinically significant hypoglycemia <54 mg/dl
timeFrame: Through study completion (Day 10 or the length of admission)
Secondary outcomes:
measure: Time above range
timeFrame: Through study completion (Day 10 or the length of admission)
measure: Time below range
timeFrame: Through study completion (Day 10 or the length of admission)
measure: Glycemic Variability [% Coefficient of Variation (%CV)
timeFrame: Through study completion (Day 10 or the length of admission)
measure: Hypoglycemic events
timeFrame: Through study completion (Day 10 or the length of admission)
measure: Hyperglycemic events
timeFrame: Through study completion (Day 10 or the length of admission)
measure: Nocturnal hypoglycemia
timeFrame: Through study completion (Day 10 or the length of admission)
measure: Prolonged hypoglycemia
timeFrame: Through study completion (Day 10 or the length of admission)
measure: Hospital Complications
timeFrame: Through study completion (Day 10 or the length of admission)
measure: Recurrent hypoglycemia
timeFrame: Through study completion (Day 10 or the length of admission)
measure: Recurrent hyperglycemia
timeFrame: Through study completion (Day 10 or the length of admission)
Other outcomes:
measure: Clinically significant hypoglycemia
timeFrame: Through study completion (Day 10 or the length of admission)
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References: