Type 2 Diabetes MellitusGLYCEM1C-LVADNCT05933161
A Study of Glycemic Control in Left Ventricular Assist
An observational study of Type 2 Diabetes Mellitus and Hyperglycemia, run by Mayo Clinic at 1 site in United States.
Trial summary
The study is being conducted to understand if the hemoglobin A1c, a measurement of control of blood sugars over a 3-month time, is valid in patients with Left Ventricular Assist Devices (LVADs) in place. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hyperglycemia, Hypoglycemia
- What is being tested?
- Freestyle Libre 3 Continuous Glucose Monitor (CGM)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2023to Jul 2027
- Phase
- Observational
- 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
Study population: Subjects diagnosed with Type 2 Diabetes Mellitus who have a Left Ventricular Assist Device (LVAD) will be recruited from the LVAD clinic at Mayo Clinic in Rochester, MN.
Who may be able to join
- Prior implantation of contemporary, centrifugal flow LVAD (HeartWare or HeartMate 3) at any time after 2010
- Diagnosis of type II diabetes mellitus
- Any antihyperglycemic regimen
- Greater than 3 months out from LVAD implantation
- Capable of utilizing smartphone device for LibreLink app for uploading glycemic data
- Patients may be enrolled who have preexisting CGM in place.
Who cannot join
- Type I diabetics
- Unable to return at 3 month evaluation
- Unwillingness to participate
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 Rochester
Rochester, Minnesota, 55905
Sarah Schettle, PA-C, (507) 293-1375, Schettle.Sarah@mayo.edu
Andrew Rosenbaum, MD, (507) 284-0783, Rosenbaum.Andrew@mayo.edu
About this study
Official title: GLYcemic Control Evaluation by Continuous Glucose Monitor Compared With a1C in Left Ventricular Assist Device-supported Patients (GLYCEM1C-LVAD)
The study is being conducted to understand if the hemoglobin A1c, a measurement of control of blood sugars over a 3-month time, is valid in patients with Left Ventricular Assist Devices (LVADs) in place. To understand whether it is an adequate measurement, the investigators will compare the A1c to results from a continuous glucose monitor (CGM) measurement of blood sugars. By monitoring blood sugars continuously, the investigators will also assess whether they can get better control of blood sugars with a CGM, including avoiding low blood sugars.
- Conditions
- Type 2 Diabetes Mellitus, Hyperglycemia, Hypoglycemia
- Being tested
- Freestyle Libre 3 Continuous Glucose Monitor (CGM)
- Keywords
- Left Ventricular Assist Device (LVAD)
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freestyle Libre 3 Continuous Glucose Monitor (CGM)Device
Subjects will be provided a Freestyle Libre 3 CGM for monitoring of blood glucose levels throughout participation in the study (approximately 3 months). CGM data will be uploaded to the LibreLink app on a weekly basis for review of glucose control and consultation with a diabetes-trained provider for any values outside of normal ranges. Adjustments to diet and medication therapy (antihyperglycemic therapy) will be made during consultations to improve episodes of hypoglycemia or severe hyperglycemia that were observed.
| Study group | Role | What they receive |
|---|---|---|
| Left Ventricular Assist Device (LVAD) supported Type 2 Diabetes Mellitus (T2DM) Subjects | Subjects diagnosed with T2DM who have a LVAD will be provided a Freestyle Libre 3 CGM. Receives: Device: Freestyle Libre 3 Continuous Glucose Monitor (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average glucose values based on continuous glucose monitoring
Average level of blood sugar reported in mg/dL obtained via the Freestyle Libre 3 CGM over a 3 month period.
Measured: 3 months
Estimated average glucose (eAG) values based on hemoglobin-A1c lab values
Estimated average level of blood sugar reported in mg/dL based on conversion of hemoglobin-A1c lab values (eAG=28.7*A1C - 46.7) collected at the 3-month visit.
Measured: 3 months
Estimated average glucose (eAG) values based on fructosamine lab values
Estimated average level of blood sugar reported in mg/dL based on conversion of fructosamine lab values (eAG= 28.7*(0.017 x fructosamine + 1.61) - 46.7) collected at the 3-month visit.
Measured: 3 months
Secondary outcomes (2)
Number of adjustments of antihyperglycemic agents
Number of adjustments made to diet and medication therapy based on consultation from a trained diabetes specialist to improve episodes of hypoglycemia or severe hyperglycemia following review of glucose levels obtained via the Freestyle Libre 3 CGM.
Measured: 3 months
Number of hypoglycemic unawareness episodes
Number of hypoglycemia unawareness episodes defined as periods where subjects did not know that they had low blood sugar according to Freestyle Libre 3 CGM generated alerts.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start10 Nov 2023
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew N Rosenbaum, Mayo Clinic
- Investigators
- Andrew Rosenbaum, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933161
- Sponsor's protocol ID
- 22-011965
- Acronym
- GLYCEM1C-LVAD
- Status last verified
- May 2026
- First submitted
- 28 Jun 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLYcemic Control Evaluation by Continuous Glucose Monitor Compared With a1C in Left Ventricular Assist Device-supported Patients (GLYCEM1C-LVAD)
- ClinicalTrials.gov ID
- NCT05933161
- Acronym / sponsor ID
- GLYCEM1C-LVAD / 22-011965
- Conditions
- Type 2 Diabetes Mellitus, Hyperglycemia, Hypoglycemia
- Keywords
- Left Ventricular Assist Device (LVAD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 6 Jul 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 study is being conducted to understand if the hemoglobin A1c, a measurement of control of blood sugars over a 3-month time, is valid in patients with Left Ventricular Assist Devices (LVADs) in place. To understand whether it is an adequate measurement, the investigators will compare the A1c to results from a continuous glucose monitor (CGM) measurement of blood sugars. By monitoring blood sugars continuously, the investigators will also assess whether they can get better control of blood sugars with a CGM, including avoiding low blood sugars.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Left Ventricular Assist Device (LVAD) supported Type 2 Diabetes Mellitus (T2DM) Subjects | – | Device: Freestyle Libre 3 Continuous Glucose Monitor (CGM)Subjects diagnosed with T2DM who have a LVAD will be provided a Freestyle Libre 3 CGM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with Type 2 Diabetes Mellitus who have a Left Ventricular Assist Device (LVAD) will be recruited from the LVAD clinic at Mayo Clinic in Rochester, MN.
Key inclusion criteria (6 listed)
- Prior implantation of contemporary, centrifugal flow LVAD (HeartWare or HeartMate 3) at any time after 2010
- Diagnosis of type II diabetes mellitus
- Any antihyperglycemic regimen
- Greater than 3 months out from LVAD implantation
- Capable of utilizing smartphone device for LibreLink app for uploading glycemic data
Key exclusion criteria (3 listed)
- Type I diabetics
- Unable to return at 3 month evaluation
- Unwillingness to participate
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 |
|---|---|---|
| Freestyle Libre 3 Continuous Glucose Monitor (CGM)Subjects will be provided a Freestyle Libre 3 CGM for monitoring of blood glucose levels throughout participation in the study (approximately 3 months). CGM data will be uploaded to the LibreLink app on a weekly basis for review of glucose control and consultation with a diabetes-trained provider for any values outside of normal ranges. Adjustments to diet and medication therapy (antihyperglycemic therapy) will be made during consultations to improve episodes of hypoglycemia or severe hyperglycemia that were observed. | Device | Left Ventricular Assist Device (LVAD) supported Type 2 Diabetes Mellitus (T2DM) Subjects |
Primary outcome
Average glucose values based on continuous glucose monitoring
Time frame: 3 months
Average level of blood sugar reported in mg/dL obtained via the Freestyle Libre 3 CGM over a 3 month period.
Estimated average glucose (eAG) values based on hemoglobin-A1c lab values
Time frame: 3 months
Estimated average level of blood sugar reported in mg/dL based on conversion of hemoglobin-A1c lab values (eAG=28.7*A1C - 46.7) collected at the 3-month visit.
Estimated average glucose (eAG) values based on fructosamine lab values
Time frame: 3 months
Estimated average level of blood sugar reported in mg/dL based on conversion of fructosamine lab values (eAG= 28.7*(0.017 x fructosamine + 1.61) - 46.7) collected at the 3-month visit.
2 secondary outcomes
Number of adjustments of antihyperglycemic agents
Time frame: 3 months
Number of hypoglycemic unawareness episodes
Time frame: 3 months
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 8 May 2026.
- Individual participant dataSharing planned: No
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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.
Andrew Rosenbaum, 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?
An observational study of Type 2 Diabetes Mellitus and Hyperglycemia, 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 6 inclusion and 3 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 8 May 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?
Contact Sarah Schettle, PA-C ((507) 293-1375, Schettle.Sarah@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average glucose values based on continuous glucose monitoring (time frame: 3 months). The study lists 3 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 8 May 2026.