Pre DiabetesPREMAPNCT06921902
Glycemic Metrics and Patterns in People With and Without Prediabetes
An observational study of Pre Diabetes, run by Abbott Diabetes Care at 1 site in United States.
Trial summary
The FreeStyle Libre 3 Continuous Glucose Monitoring (FSL3) System is used to characterize the glycemic profiles of people with and without a prediabetes diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre Diabetes
- What is being tested?
- FreeStyle Libre 3
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2025to Dec 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be stratified into groups, including male and female sex, race, age and Body Mass Index. Approximately 25 evaluable subjects will be enrolled into each group.
Who may be able to join
- Subject must be at least 18 years of age.
- Subject must be willing and able to provide written signed and dated informed consent.
Who cannot join
- Subject has a diagnosis of type 1 diabetes, type 2 diabetes, or gestational diabetes.
- Subject is known to be currently practicing a low-carbohydrate or ketogenic diet at the time of enrollment.
- Subject is known to be pregnant at the time of enrollment.
- Subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethyl alcohol used to disinfect skin.
- Subject is currently on any form of treatment indicated for the treatment of diabetes.
- Subject is currently on any form of medication indicated for weight loss.
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
Diabetes and Obesity Care
Bend, Oregon, 97702
Eden Miller, D.O.
About this study
Official title: Observation and Identification of Glycemic Metrics and Patterns in People With and Without Prediabetes (PREMAP)
The FreeStyle Libre 3 Continuous Glucose Monitoring (FSL3) System is used to characterize the glycemic profiles of people with and without a prediabetes diagnosis.
Read the detailed description
This is a non-pivotal, non-randomized, multi-center, prospective, non-significant risk to evaluate the glycemic profiles of people with and without a prediabetes diagnosis using continuous glucose monitoring. Up to 2000 subjects will be enrolled in up to 20 sites. Approximately 50% of evaluable subjects will have a prediabetes diagnosis.
- Conditions
- Pre Diabetes
- Being tested
- FreeStyle Libre 3
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle Libre 3Device
Also called FreeStyle Libre 3 Monitoring System
Abbott Sensor Based Glucose Monitoring System (FreeStyle Libre 3 System)
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the glycemic profiles of people with and without a prediabetes diagnosis.
This is a data collection study.
Measured: up to 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start28 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre DiabetesStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shridhara Karinka, PhD, Study chair, Abbott Diabetes Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921902
- Sponsor's protocol ID
- ADC-US-RES-23243
- Acronym
- PREMAP
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2025
- Last updated
- 9 Apr 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 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation and Identification of Glycemic Metrics and Patterns in People With and Without Prediabetes (PREMAP)
- ClinicalTrials.gov ID
- NCT06921902
- Acronym / sponsor ID
- PREMAP / ADC-US-RES-23243
- Conditions
- Pre Diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Apr 2025 (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 FreeStyle Libre 3 Continuous Glucose Monitoring (FSL3) System is used to characterize the glycemic profiles of people with and without a prediabetes diagnosis.
Detailed description
This is a non-pivotal, non-randomized, multi-center, prospective, non-significant risk to evaluate the glycemic profiles of people with and without a prediabetes diagnosis using continuous glucose monitoring. Up to 2000 subjects will be enrolled in up to 20 sites. Approximately 50% of evaluable subjects will have a prediabetes diagnosis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be stratified into groups, including male and female sex, race, age and Body Mass Index. Approximately 25 evaluable subjects will be enrolled into each group.
Key inclusion criteria (2 listed)
- Subject must be at least 18 years of age.
- Subject must be willing and able to provide written signed and dated informed consent.
Key exclusion criteria (6 listed)
- Subject has a diagnosis of type 1 diabetes, type 2 diabetes, or gestational diabetes.
- Subject is known to be currently practicing a low-carbohydrate or ketogenic diet at the time of enrollment.
- Subject is known to be pregnant at the time of enrollment.
- Subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethyl alcohol used to disinfect skin.
- Subject is currently on any form of treatment indicated for the treatment of diabetes.
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 3Also: FreeStyle Libre 3 Monitoring SystemAbbott Sensor Based Glucose Monitoring System (FreeStyle Libre 3 System) | Device | – |
Primary outcome
Characterize the glycemic profiles of people with and without a prediabetes diagnosis.
Time frame: up to 50 days
This is a data collection study.
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 9 Apr 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.
Shridhara Karinka, PhD study chair
Abbott Diabetes Care
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 Pre Diabetes, run by Abbott Diabetes Care 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 2 inclusion and 6 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 9 Apr 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 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?
Characterize the glycemic profiles of people with and without a prediabetes diagnosis. (time frame: up to 50 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 9 Apr 2026.