Diabetes MellitusNCT05880810
Continuous Glucose Monitor for Mayo Clinic Advanced Care at Home Patients
A study testing Continuous Glucose Monitor Dexcom G6 PRO in people with Diabetes Mellitus, run by Mayo Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Continuous Glucose Monitor Dexcom G6 PRO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Adrian Dumitrascu, MD, 904-953-2000, Dumitrascu.Adrian@mayo.edu
About this study
Official title: Continuous Glucose Monitor Use for Mayo Clinic Advanced Care at Home Patients With Diabetes Mellitus
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).
- Conditions
- Diabetes Mellitus
- Being tested
- Continuous Glucose Monitor Dexcom G6 PRO
- Keywords
- Advanced Care at Home Program (home hospital)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range
Percentage of time with continuous glucose monitor values within 70-180 mg/dl
Measured: 10 days
Mean daily glucose
Mean daily glucose level (mg/dl)
Measured: 10 days
Secondary outcomes (6)
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)
Measured: 10 days
Mean absolute relative difference (MARD) variation with Oxygen saturation.
Measured in percentage
Measured: 10 days
Mean absolute relative difference (MARD) variation with Daily hemoglobin.
Measured in grams per deciliter (g/dl)
Measured: 10 days
Mean absolute relative difference (MARD) variation with Glomerular filtration rate (GFR)
Measured in ml/min
Measured: 10 days
Mean absolute relative difference (MARD) variation with Arterial blood pressure
Measured in millimeters of mercury (mmHg)
Measured: 10 days
Percentage of subjects to continue use of continuous glucose monitor
Percentage of subjects will using continuous glucose monitor at 40 days post enrollment
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 May 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian G. Dumitrascu, Mayo Clinic
- Investigators
- Adrian Dumitrascu, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880810
- Sponsor's protocol ID
- 23-000733
- Status last verified
- Jun 2026
- First submitted
- 16 May 2023
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitor Use for Mayo Clinic Advanced Care at Home Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05880810
- Acronym / sponsor ID
- 23-000733
- Conditions
- Diabetes Mellitus
- Keywords
- Advanced Care at Home Program (home hospital)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitoring | Experimental | Device: Continuous Glucose Monitor Dexcom G6 PROSubjects 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose Monitor Dexcom G6 PROConnected to a smart phone that transmits continuous glucose monitoring data in real time to Advanced Care at Home Command Center for monitoring. | Device | Continuous Glucose Monitoring |
Primary outcome
Time in Range
Time frame: 10 days
Percentage of time with continuous glucose monitor values within 70-180 mg/dl
Mean daily glucose
Time frame: 10 days
Mean daily glucose level (mg/dl)
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adrian Dumitrascu, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitor Dexcom G6 PRO in people with Diabetes Mellitus, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Range (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.