Using continuous glucose monitors for diabetes management at home
Continuous Glucose Monitor Use for Mayo Clinic Advanced Care at Home Patients With Diabetes Mellitus
This study is testing if using a continuous glucose monitor at home can help people with diabetes manage their blood sugar better than regular blood sugar checks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT05880810 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of continuous glucose monitoring (CGM) using the Dexcom G6 PRO in patients with diabetes mellitus who are part of the Mayo Clinic Advanced Care at Home Program. Participants will receive diabetes education alongside CGM, and their glucose control will be compared to those receiving standard care with glucometer checks. The study focuses on patients who are on insulin therapy and are expected to stay in the program for at least 72 hours. The goal is to determine if CGM can improve diabetes management in a home care setting.
Who should consider this trial
Good fit: Ideal candidates include patients with type 1 or type 2 diabetes who are on insulin therapy and admitted to the Advanced Care at Home Program.
Not a fit: Patients actively treated for diabetic ketoacidosis, those with altered mental status, or those with severe comorbidities such as end-stage renal disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better diabetes control and improved patient outcomes for those managing their condition at home.
How similar studies have performed: Other studies have shown promising results with continuous glucose monitoring in diabetes management, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who are admitted to Advanced Care at Home (ACH) Program and supposed to remain in ACH for at least 72 hours. * Patients with previous diagnosis of DM type 1 or type 2. * Patients taking subcutaneous (SQ) insulin either via multidose injections or SQ insulin pump. * Capable of giving signed informed consent Exclusion Criteria: * Actively treated for diabetes ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS). * Participants taking acetaminophen more than 4g per day or more than 1gm every 6 hours. * Participants with altered mental status. * Participants diagnosed with dementia. * Patients with suicidal ideations or experiencing suicidal behavior. * Patients with liver cirrhosis. * Patients with End Stage Renal Disease on dialysis bot hemodialysis or peritoneal dialysis. * Participants with allergy to medical grade adhesive or medical tape. * Participants taking hydroxyurea. * Participants who are pregnant, wanting to become pregnant, or nursing during study period. * Patients with a planned MRI within the following 10 days after admission to ACH. * Participants currently using continuous glucose monitor (CGM) to dose insulin or check glucose level. * Participants with diabetes mellitus (DM) treated with diet alone. * Participants with DM treated with oral hypoglycemic medications. * Participants with DM treated with one SQ insulin injection daily. * Participants enrolled in other studies addressing CGM use. * Participants physically or emotionally incapable of handling a cell phone with a smart display. * Participants with hearing impaired to a degree that they are not able to hear a smart phone alert or alarm. * Patients lacking WIFI or Cellular coverage needed to connect the monitoring cell phone to Internet network.
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Adrian Dumitrascu, MD — Mayo Clinic
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.