Diabetes MellitusNCT06668935
Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring
An observational study of Diabetes Mellitus, run by Abbott Diabetes Care at 8 sites in United States.
Trial summary
This study is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) will help prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1/GIP) agonists. 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?
- To utilize the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) to help prolong the length of time people with diabetes maintain adherence to GLP-1 and dual GIP/GLP-1 agonists
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- 8 sitesUnited States
- Study dates
- 24 Oct 2024to Dec 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 with type 2 diabetes who are newly beginning GLP-1 or dual GLP-1/GIP drug therapy will be randomized to use either the FSL3 or their existing Standard of Care (SOC) to manage their diabetes.
Who may be able to join
- Subject must be at least 18 years of age.
- Subject must be able to read and understand English.
- Subject must have a type 2 diabetes diagnosis.
- In the investigator's opinion, subject must meet the criteria for beginning use of GLP-1 or GIP/GLP-1 medications for management of their diabetes.
- Subject is beginning use of GLP-1 / GIP/GLP-1 medication for management of their diabetes.
- Subject must be willing to allow venous samples to be obtained to test HbA1c.
Show all 10Show fewer
- Subject must be willing to either continue using their existing standard of care device or must be willing to use the FreeStyle Libre 3 Continuous Glucose Monitoring System to manage their diabetes throughout the duration of the study.
- In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
- Subject must be available to participate in all study visits.
- Subject must be willing and able to provide written signed and dated informed consent.
Who cannot join
- Subject is a member of the Study Staff.
- Subject has a diagnosis of type 1 or gestational diabetes.
- Subject is currently using or has previously used GLP-1 or GIP/GLP-1 drugs for any reason.
- Subject is currently using a Continuous Glucose Monitor (CGM) as their standard of care device to manage their diabetes.
- Subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethyl alcohol used to disinfect skin.
- Subject is taking any type of rapid-acting insulin, including Neutral Protamine Hagedorn (NPH) and premix insulin.
Show all 9Show fewer
- Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff.
- Subject currently is participating in another clinical trial.
- Subject is unsuitable for participation due to any other cause as determined by the Investigator
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
M3 Wake Research, Inc
Dallas, Texas, 75246
Carlos Arause-Pacheco, MD, 469-297-3074, carauzpacheco@wakeresearch.com
Alexus Washington, 469-297-3074, amwashington@wakeresearch.com
- Recruiting
Cross Creek Medical Clinic, PA
Fayetteville, North Carolina, 28304
Nitinchandra Desai, MD, 910-437-5130, dr.desai@crosscreekmedical.com
Melissa Thompson, 910-437-5130, melissa@crosscreekmedical.com
- Recruiting
Care United Research
Forney, Texas, 75126
Jennifer Jasso-Burkemper, MS, 972-564-0044, jennifer.jasso@careunitedresearch.com
Shilpi Mittal, MD, MD, 972-564-0044, shilpi.mittal@careunitedresearch.com
- Recruiting
Medication Management
Greensboro, North Carolina, 27405
James Franklin, MD, 336-763-6968, James.Franklin@emailmm.com
Bryan Bray, Pharm D, 336-763-6968, Bryan.Bray@emailmm.com
- Recruiting
East Coast Institute for Research, LLC
Jacksonville, Florida, 32216
Rebecca Goldfaden, Pharm D, 904-854-1354, rg@eastcoastresearch.net
Wasim Deeb, MD
- Recruiting
Excellence Medical and Research
Miami Gardens, Florida, 33169
Alexander Martinez, OD, 786-320-5229, amartinez@emrclinic.com
Miguel Trujillo, DNP
- Recruiting
Helios Clinical Research
Paradise Valley, Arizona, 85253
Gerald Asin, MD, 480-591-7139, Gerald.Asin@heliosclinical.com
Debra Goldman, APRN, 480-591-7139, Debra.goldman@heliosclinical.com
- Recruiting
American Research Centers of Florida
Pembroke Pines, Florida, 33027
Mileydis Rivero, DNP, 954-237-3799, mrivero@americanresearchcenters.com
Luis Rodriguez, MD, 954-237-3801, lprado@americanresearchcenters.com
About this study
This study is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) will help prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1/GIP) agonists.
Read the detailed description
Subjects with type 2 diabetes who are newly beginning GLP-1 or GLP-1/GIP drug therapy will be randomized to use either FSL3 or their existing Standard of Care to manage their diabetes. Up to 800 subjects will be enrolled across the United States with 200 evaluable subjects in each group (intervention and control) for a total of 400 evaluable subjects. Subjects will be on the study approximately 210 days. Subjects will wear one sensor applied to the back of the upper arm and will have a paired smartphone that will be used to start the sensor and collect glucose readings.
- Conditions
- Diabetes Mellitus
- Being tested
- To utilize the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) to help prolong the length of time people with diabetes maintain adherence to GLP-1 and dual GIP/GLP-1 agonists
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To utilize the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) to help prolong the length of time people with diabetes maintain adherence to GLP-1 and dual GIP/GLP-1 agonistsDevice
All subjects will then begin use of their prescribed GLP-1 or combination GIP/GLP-1 medication in accordance with the HCP's instructions. Subjects will be titrated to their maximum tolerable dose per the medication's approved titration schedule and according to their HCP's standard of care between Visits 2 and 3.
| Study group | Role | What they receive |
|---|---|---|
| Randomization to FSL 3 or Standard of Care | Subjects with type 2 diabetes who are newly beginning GLP-1 or dual GLP-1/GIP drug therapy will be randomized to use either the FSL3 or their existing Standard of Care (SOC) to manage their diabetes. Receives: Device: To utilize the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) to help prolong the length of time people with diabetes maintain adherence to GLP-1 and dual GIP/GLP-1 agonists |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the length of time subjects in each group remain on a GLP-1 or GLP-1/GIP combination drug
The primary outcome is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) helps prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1) and dual gastric inhibitory polypeptide/glucagon-like peptide 1 (GIP/GLP-1) agonists.
Measured: 210 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start24 Oct 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 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.
- 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668935
- Sponsor's protocol ID
- ADC-US-RES-24254
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT06668935
- Acronym / sponsor ID
- ADC-US-RES-24254
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Nov 2024 (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.
This study is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) will help prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1/GIP) agonists.
Detailed description
Subjects with type 2 diabetes who are newly beginning GLP-1 or GLP-1/GIP drug therapy will be randomized to use either FSL3 or their existing Standard of Care to manage their diabetes. Up to 800 subjects will be enrolled across the United States with 200 evaluable subjects in each group (intervention and control) for a total of 400 evaluable subjects. Subjects will be on the study approximately 210 days. Subjects will wear one sensor applied to the back of the upper arm and will have a paired smartphone that will be used to start the sensor and collect glucose readings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Randomization to FSL 3 or Standard of Care | – | Device: To utilize the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) to help prolong the length of time people with diabetes maintain adherence to GLP-1 and dual GIP/GLP-1 agonistsSubjects with type 2 diabetes who are newly beginning GLP-1 or dual GLP-1/GIP drug therapy will be randomized to use either the FSL3 or their existing Standard of Care (SOC) to manage their diabetes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with type 2 diabetes who are newly beginning GLP-1 or dual GLP-1/GIP drug therapy will be randomized to use either the FSL3 or their existing Standard of Care (SOC) to manage their diabetes.
Key inclusion criteria (10 listed)
- Subject must be at least 18 years of age.
- Subject must be able to read and understand English.
- Subject must have a type 2 diabetes diagnosis.
- In the investigator's opinion, subject must meet the criteria for beginning use of GLP-1 or GIP/GLP-1 medications for management of their diabetes.
- Subject is beginning use of GLP-1 / GIP/GLP-1 medication for management of their diabetes.
Key exclusion criteria (9 listed)
- Subject is a member of the Study Staff.
- Subject has a diagnosis of type 1 or gestational diabetes.
- Subject is currently using or has previously used GLP-1 or GIP/GLP-1 drugs for any reason.
- Subject is currently using a Continuous Glucose Monitor (CGM) as their standard of care device to manage their diabetes.
- Subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethyl alcohol used to disinfect skin.
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 |
|---|---|---|
| To utilize the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) to help prolong the length of time people with diabetes maintain adherence to GLP-1 and dual GIP/GLP-1 agonistsAll subjects will then begin use of their prescribed GLP-1 or combination GIP/GLP-1 medication in accordance with the HCP's instructions. Subjects will be titrated to their maximum tolerable dose per the medication's approved titration schedule and according to their HCP's standard of care between Visits 2 and 3. | Device | Randomization to FSL 3 or Standard of Care |
Primary outcome
To assess the length of time subjects in each group remain on a GLP-1 or GLP-1/GIP combination drug
Time frame: 210 days
The primary outcome is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) helps prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1) and dual gastric inhibitory polypeptide/glucagon-like peptide 1 (GIP/GLP-1) agonists.
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 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Abbott Diabetes Care at 8 sites 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 10 inclusion and 9 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 Mohamed Mohamed Nada, PhD (5107495416, adc.clinical@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the length of time subjects in each group remain on a GLP-1 or GLP-1/GIP combination drug (time frame: 210 days). 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 27 Oct 2026.