NCT05880810

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
12mo left

Started May 2024

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
May 2024May 2027

First Submitted

Initial submission to the registry

May 16, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

May 16, 2023

Last Update Submit

May 30, 2025

Conditions

Diabetes Mellitus

Keywords

Advanced Care at Home Program (home hospital)

Outcome Measures

Primary Outcomes (2)

  • Time in Range

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

    10 days

  • Mean daily glucose

    Mean daily glucose level (mg/dl)

    10 days

Secondary Outcomes (6)

  • Frequency of hypoglycemia episodes

    10 days

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

    10 days

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

    10 days

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

    10 days

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

    10 days

  • +1 more secondary outcomes

Study Arms (2)

Continuous Glucose Monitoring

EXPERIMENTAL

Subjects admitted to the Advanced Care at Home program (home hospital) will have the continuous glucose monitor sensor placed for up to 10 days to monitor and dose insulin.

Device: Continuous Glucose Monitor Dexcom G6 PRO

Control Arm (Standard of Care)

NO INTERVENTION

Subjects admitted to the Advanced Care at Home program (home hospital) will continue with standard of care glucose monitoring (capillary glucose levels checked via glucometer), insulin dosing, and DM treatment during the 10 day period.

Interventions

Continuous Glucose Monitor Dexcom G6 PRODEVICE

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

Continuous Glucose Monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Adrian Dumitrascu, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 16, 2023

First Posted

May 30, 2023

Study Start

May 1, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

June 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)