Type 1 Diabetes
Conditions
Keywords
Continuous Glucose Monitoring, Type 1 Diabetes Mellitus, Point of Care
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.
Interventions
DEVICEDexcom 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
DIAGNOSTIC_TESTCapillary 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.
Sponsors
DexCom, Inc.
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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 |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinically significant hypoglycemia | Through study completion (Day 10 or the length of admission) | Number of clinically significant hypoglycemic episodes: \<54 mg/dl |
Countries
United States
Contacts
Primary ContactGuillermo Umpierrez, MD
Outcome results
None listed