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Recruiting NCT05880810

Continuous Glucose Monitor for Mayo Clinic Advanced Care at Home Patients

No phase Interventional Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Continuous Glucose Monitor Dexcom G6 PRO.
Who it may be relevant to
Registry conditions: Diabetes Mellitus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Time in Range [Time frame: 10 days]
  • Mean daily glucose [Time frame: 10 days]
Secondary outcome measures (6)
  • Frequency of hypoglycemia episodes [Time frame: 10 days]
  • Mean absolute relative difference (MARD) variation with Oxygen saturation. [Time frame: 10 days]
  • Mean absolute relative difference (MARD) variation with Daily hemoglobin. [Time frame: 10 days]
  • Mean absolute relative difference (MARD) variation with Glomerular filtration rate (GFR) [Time frame: 10 days]
  • Mean absolute relative difference (MARD) variation with Arterial blood pressure [Time frame: 10 days]
  • Percentage of subjects to continue use of continuous glucose monitor [Time frame: 40 days]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Florida — Jacksonville

Identifiers

NCT: NCT05880810 · 23-000733

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗