Diabetes Mellitus, Type 2NCT04843527
Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People With T2 Diabetes
A study testing FreeStyle Libre System and FreeStyle Libre System plus food app in people with Diabetes Mellitus, Type 2, run by Abbott Diabetes Care at 4 sites in United States.
Trial summary
A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre Flash Glucose Monitoring System with and without a food logging smartphone application on reducing time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- FreeStyle Libre System and FreeStyle Libre System plus food app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Apr 2021to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subject must be at least 18 years of age.
- Subject has been diagnosed with type 2 diabetes.
- HbA1c greater than or equal to 7.5% and less than or equal to 12%
- Subject is on at least 1 diabetes medication in the classes of metformin, SGLT-2 inhibitors, GLP-1 agonists and DPP-4 inhibitors.
- Subject owns a compatible smartphone
- Subject agrees to a 3-month period of no diabetes medication changes.
- Subject is willing to make diet and lifestyle changes in response to education and glucose data
Who cannot join
- Subject is currently on insulin therapy or sulfonylurea-based medications.
- Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Subject is known to be pregnant at the time of study enrollment (applicable to female subjects only).
- Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Boston Medical Center
Boston, Massachusetts, 02118
Henry Ford Health System
Detroit, Michigan, 48202
HealthPartners Institute dba International Diabetes Center
Minneapolis, Minnesota, 55416
UMPC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People
A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre Flash Glucose Monitoring System with and without a food logging smartphone application on reducing time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen.
Read the detailed description
Approximately 350 subjects will be enrolled to obtain at least 84 randomized subjects,approximately 42 subjects per arm. Subjects will be randomized to use either the FreeStyle Libre Flash Glucose Monitoring System or FreeStyle Libre Flash Glucose Monitoring System with a food logging smartphone application to manage their diabetes.
The subsequent impact on reducing the amount of time spent above 180 mg/dL will be assessed.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- FreeStyle Libre System, FreeStyle Libre System plus food app
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle Libre SystemDevice
FreeStyle Libre Flash Glucose Monitoring System
FreeStyle Libre System plus food appDevice
FreeStyle Libre Flash Glucose Monitoring System and Smartphone Food Logging application
| Study group | Role | What they receive |
|---|---|---|
| FreeStyle Libre | Active comparator | Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System to manage their diabetes. Receives: Device: FreeStyle Libre System |
| FreeStyle Libre plus food logging | Active comparator | Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System and a food logging smartphone application to manage their diabetes. Receives: Device: FreeStyle Libre System plus food app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on time above 180 mg/dL
To assess the impact of the FreeStyle Libre Flash Glucose Monitoring System with and with food logging app on time above 180 mg/dL
Measured: Three (3) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start2 Apr 2021
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shridhara A Karinka, PhD, Study director, Abbott Diabetes Care Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843527
- Sponsor's protocol ID
- ADC-US-RES-19185
- Status last verified
- Jan 2024
- First submitted
- 9 Apr 2021
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Martens TW, Willis HJ, Bergenstal RM, Kruger DF, Karslioglu-French E, Steenkamp DW. A Randomized Controlled Trial Using Continuous Glucose Monitoring to Guide Food Choices and Diabetes Self-Care in People with Type 2 Diabetes not Taking Insulin. Diabetes Technol Ther. 2025 Apr;27(4):261-270. doi: 10.1089/dia.2024.0579. Epub 2025 Jan 6.
PubMed 39757879
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People
- ClinicalTrials.gov ID
- NCT04843527
- Acronym / sponsor ID
- ADC-US-RES-19185
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 13 Apr 2021 (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.
A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre Flash Glucose Monitoring System with and without a food logging smartphone application on reducing time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen.
Detailed description
Approximately 350 subjects will be enrolled to obtain at least 84 randomized subjects,approximately 42 subjects per arm. Subjects will be randomized to use either the FreeStyle Libre Flash Glucose Monitoring System or FreeStyle Libre Flash Glucose Monitoring System with a food logging smartphone application to manage their diabetes.
The subsequent impact on reducing the amount of time spent above 180 mg/dL will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FreeStyle Libre | Active comparator | Device: FreeStyle Libre SystemSubjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System to manage their diabetes. |
| FreeStyle Libre plus food logging | Active comparator | Device: FreeStyle Libre System plus food appSubjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System and a food logging smartphone application to manage their diabetes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must be at least 18 years of age.
- Subject has been diagnosed with type 2 diabetes.
- HbA1c greater than or equal to 7.5% and less than or equal to 12%
- Subject is on at least 1 diabetes medication in the classes of metformin, SGLT-2 inhibitors, GLP-1 agonists and DPP-4 inhibitors.
- Subject owns a compatible smartphone
Key exclusion criteria (4 listed)
- Subject is currently on insulin therapy or sulfonylurea-based medications.
- Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Subject is known to be pregnant at the time of study enrollment (applicable to female subjects only).
- Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
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 SystemFreeStyle Libre Flash Glucose Monitoring System | Device | FreeStyle Libre |
| FreeStyle Libre System plus food appFreeStyle Libre Flash Glucose Monitoring System and Smartphone Food Logging application | Device | FreeStyle Libre plus food logging |
Primary outcome
Impact on time above 180 mg/dL
Time frame: Three (3) months
To assess the impact of the FreeStyle Libre Flash Glucose Monitoring System with and with food logging app on time above 180 mg/dL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Derived from this study: PubMed 39757879Martens TW, Willis HJ, Bergenstal RM, Kruger DF, Karslioglu-French E, Steenkamp DW. A Randomized Controlled Trial Using Continuous Glucose Monitoring to Guide Food Choices and Diabetes Self-Care in People with Type 2 Diabetes not Taking Insulin. Diabetes Technol Ther. 2025 Apr;27(4):261-270. doi: 10.1089/dia.2024.0579. Epub 2025 Jan 6.
- 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. This study is not recruiting at the moment.
Shridhara A Karinka, PhD study director
Abbott Diabetes Care Inc
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeStyle Libre System and FreeStyle Libre System plus food app in people with Diabetes Mellitus, Type 2, run by Abbott Diabetes Care at 4 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on time above 180 mg/dL (time frame: Three (3) months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04843527, which also lists 1 linked publication.
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 30 Jan 2025.