Comparing Dexcom G7 continuous glucose monitoring versus fingerstick point-of-care testing for hospitalized and recently discharged people with type 1 diabetes.
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
This study will test whether using the Dexcom G7 continuous glucose monitor instead of routine fingerstick point-of-care checks helps hospitalized people with poorly controlled type 1 diabetes stay in the 70–180 mg/dL range longer and have fewer low blood sugars.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06752928 on ClinicalTrials.gov |
What this trial studies
Hospitalized adults with poorly controlled type 1 diabetes who expect to stay more than three days will be assigned to either real-time Dexcom G7 continuous glucose monitoring or standard point-of-care capillary glucose testing to guide insulin therapy. The study will track percent time-in-range (70–180 mg/dL) and the frequency of hypoglycemia during the inpatient stay and shortly after discharge. Key exclusions include ICU admission, prior home CGM use, pregnancy, MRI requirement during admission, systemic immunosuppression, and type 2 diabetes. Results aim to determine whether CGM provides a clearer glycemic picture and fewer low or high glucose events than routine fingerstick testing in this population.
Who should consider this trial
Good fit: Ideal candidates are adults with diagnosed type 1 diabetes on insulin who are hospitalized with poorly controlled glucose (blood glucose >180 mg/dL or HbA1c >7%), are not already using CGM, and are expected to remain in hospital more than three days outside of the ICU.
Not a fit: Patients in the ICU, people already using CGM before admission, those with type 2 diabetes, pregnant or breastfeeding patients, those needing MRI while admitted, or patients unwilling to wear a CGM are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, using Dexcom G7 CGM could increase time spent in the target glucose range and reduce hypoglycemic events during and after hospitalization for people with type 1 diabetes.
How similar studies have performed: Prior studies and trials in type 2 diabetes and non-randomized inpatient work with Dexcom systems have shown improved detection of hypo- and hyperglycemia and fewer low-glucose events, but randomized data specific to hospitalized type 1 diabetes are limited or lacking.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia
- Grady Memorial Hospital — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Guillermo Umpierrez, MD — Emory University
- Study coordinator: Guillermo Umpierrez, MD
- Email: geumpie@emory.edu
- Phone: 404-778-1665
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.