Health TrialsbyHealthPanel

Continuous Glucose Monitor for Mayo Clinic Advanced Care at Home Patients

ConditionDiabetes Mellitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Continuous Glucose MonitoringExperimental treatment 1 intervention
Group B: Control Arm (Standard of Care)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Time in Range

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

Time frame
10 days
2

Mean daily glucose

Mean daily glucose level (mg/dl)

Time frame
10 days

Secondary outcomes

1

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)

Time frame
10 days
2

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

Measured in percentage

Time frame
10 days
3

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

Measured in grams per deciliter (g/dl)

Time frame
10 days
4

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

Measured in ml/min

Time frame
10 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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