Continuous Glucose Monitor for Mayo Clinic Advanced Care at Home Patients

Diabetes Mellitus Clinical Trial

Official title:

Continuous Glucose Monitor Use for Mayo Clinic Advanced Care at Home Patients With Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05880810
• Other study ID #: 23-000733
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Continuous 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in Range	Percentage of time with continuous glucose monitor values within 70-180 mg/dl	10 days
Primary	Mean daily glucose	Mean daily glucose level (mg/dl)	10 days
Secondary	Frequency of hypoglycemia episodes	Number of episodes with blood glucose below 70 mg/dl measured via point of care testing (POCT) and Continuous Glucose Monitor (CGM)	10 days
Secondary	Mean absolute relative difference (MARD) variation with Oxygen saturation.	Measured in percentage	10 days
Secondary	Mean absolute relative difference (MARD) variation with Daily hemoglobin.	Measured in grams per deciliter (g/dl)	10 days
Secondary	Mean absolute relative difference (MARD) variation with Glomerular filtration rate (GFR)	Measured in ml/min	10 days
Secondary	Mean absolute relative difference (MARD) variation with Arterial blood pressure	Measured in millimeters of mercury (mmHg)	10 days
Secondary	Percentage of subjects to continue use of continuous glucose monitor	Percentage of subjects will using continuous glucose monitor at 40 days post enrollment	40 days