Diabetes Mellitus
Conditions
Keywords
Advanced Care at Home Program (home hospital)
Brief summary
The purpose of this study is to measure differences in diabetes control with the use of continuous glucose monitor (CGM) and diabetes education compared with standard of care for glucose monitoring (glucometer checks) and diabetes education in participants with diabetes mellitus receiving therapy with insulin and being admitted to Mayo Clinic Advanced Care at Home Program (ACH).
Interventions
DEVICEContinuous Glucose Monitor Dexcom G6 PRO
Connected to a smart phone that transmits continuous glucose monitoring data in real time to Advanced Care at Home Command Center for monitoring.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range | 10 days | Percentage of time with continuous glucose monitor values within 70-180 mg/dl |
| Mean daily glucose | 10 days | Mean daily glucose level (mg/dl) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of hypoglycemia episodes | 10 days | Number of episodes with blood glucose below 70 mg/dl measured via point of care testing (POCT) and Continuous Glucose Monitor (CGM) |
| Mean absolute relative difference (MARD) variation with Oxygen saturation. | 10 days | Measured in percentage |
| Mean absolute relative difference (MARD) variation with Daily hemoglobin. | 10 days | Measured in grams per deciliter (g/dl) |
| Mean absolute relative difference (MARD) variation with Glomerular filtration rate (GFR) | 10 days | Measured in ml/min |
| Mean absolute relative difference (MARD) variation with Arterial blood pressure | 10 days | Measured in millimeters of mercury (mmHg) |
| Percentage of subjects to continue use of continuous glucose monitor | 40 days | Percentage of subjects will using continuous glucose monitor at 40 days post enrollment |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAdrian Dumitrascu, MD
Mayo Clinic
Outcome results
None listed