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NCT Number: NCT05880810

Continuous Glucose Monitor for Mayo Clinic Advanced Care at Home Patients

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).

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location status: Recruiting

Location contact

Adrian Dumitrascu, MD

CONTACT

[email protected]

904-953-2000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous Glucose Monitor Dexcom G6 PRO

Device

Connected to a smart phone that transmits continuous glucose monitoring data in real time to Advanced Care at Home Command Center for monitoring.

Primary outcomes

  1. Time in Range

    Time frame: 10 days

    Percentage of time with continuous glucose monitor values within 70-180 mg/dl

  2. Mean daily glucose

    Time frame: 10 days

    Mean daily glucose level (mg/dl)

Secondary outcomes

  1. Frequency of hypoglycemia episodes

    Time frame: 10 days

    Number of episodes with blood glucose below 70 mg/dl measured via point of care testing (POCT) and Continuous Glucose Monitor (CGM)

  2. Mean absolute relative difference (MARD) variation with Oxygen saturation.

    Time frame: 10 days

    Measured in percentage

  3. Mean absolute relative difference (MARD) variation with Daily hemoglobin.

    Time frame: 10 days

    Measured in grams per deciliter (g/dl)

  4. Mean absolute relative difference (MARD) variation with Glomerular filtration rate (GFR)

    Time frame: 10 days

    Measured in ml/min

  5. Mean absolute relative difference (MARD) variation with Arterial blood pressure

    Time frame: 10 days

    Measured in millimeters of mercury (mmHg)

  6. Percentage of subjects to continue use of continuous glucose monitor

    Time frame: 40 days

    Percentage of subjects will using continuous glucose monitor at 40 days post enrollment

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 30, 2023
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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