Diabetes Mellitus, Type 2NCT05168306
T2 FSL2 Weight Loss
An observational study of Diabetes Mellitus, Type 2, run by Abbott Diabetes Care at 1 site in United States.
Trial summary
To compare the impact of the FreeStyle Libre (FSL) 2 Flash Glucose Monitoring System to the current Diabetes Monitoring standard of care (SOC) on weight reduction in subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- FreeStyle Libre 2 Flash Glucose Monitoring System
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2021to 19 Jul 2023
- Phase
- Observational
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have been diagnosed with type 2 diabetes
Who may be able to join
- Subject must be at least 30 years of age and no more than 70 years of age at the time of enrollment.
- Subject must have laboratory-based HbA1c measurement of between 8.0% and 10.0%.
- Subject has 25% or more time spent above 180 mg/dL between the hours of 6am and 10pm during the screening phase.
- Subject has a Body Mass Index (BMI) of 30 or greater.
- Subject must have had a diagnosis of type 2 diabetes.
- Subject must be able to read and understand English and/or Spanish.
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- 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 is willing to make diet and lifestyle changes in response to education and glucose data
- 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 unable to perform mild physical activity (i.e. walking, stationary bike, etc.) for a minimum of 20 minutes per day.
- Subject has used an unblinded continuous glucose monitor in the three (3) months prior to enrollment.
- Subject is currently on any form of insulin therapy.
- Subject is currently on a low carbohydrate diet.
- Subject is currently using a commercial structured-meal weight loss program (i.e. Nutrisystem)
- Subject is currently taking sulfonylurea-based medications.
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- Subject has experienced weight loss or gain of 5% or more of their total weight within the past 90 days.
- Subject is currently taking prescription weight loss drugs, including, but not limited to, bupropion-naltrexone (Contrave), liraglutide (Saxenda), orlistat (Xenical), phentermine-topiramate (Qsymia) and semaglutide (Wegovy).
- Subject is currently taking over-the-counter medications or supplements purported to aid in weight loss.
- Subject is currently taking intramuscular or intravenous corticosteroids.
- Subject has previously undergone or is planning on undergoing gastric bypass, gastric banding or gastric sleeve surgery in the next six (6) months.
- Subject is currently taking atypical antipsychotic medications.
- Subject has a condition that can lead to development of secondary diabetes (including but not limited to cystic fibrosis, hemochromatosis, chronic pancreatitis, polycystic ovary syndrome (PCOS), Cushing's syndrome, having undergone a pancreatectomy).
- Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration (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. Such conditions include, but are not limited to extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, redness, infection or edema.
- Subject is currently undergoing or is anticipated to undergo treatment for cancer (including but not limited to oral and/or intravenous chemotherapy, radiation treatment, surgery, bone marrow transplant).
- Subject has untreated mental illness and/or opiate addiction.
- Subject has concomitant medical condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the subject or study staff.
- Subject is currently undergoing dialysis and/or has end stage renal disease.
- Subject is currently participating in another interventional clinical trial.
- Subject is unsuitable for participation due to any other cause as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rainier Clinical Research Center
Renton, Washington, 98057
About this study
Official title: Evaluation of the Impact of the FreeStyle Libre 2 Flash Glucose Monitoring System, Compared to the Current Standard of Care (SOC), on Weight Reduction in Subjects With Type 2 Diabetes.
To compare the impact of the FreeStyle Libre (FSL) 2 Flash Glucose Monitoring System to the current Diabetes Monitoring standard of care (SOC) on weight reduction in subjects with type 2 diabetes.
Read the detailed description
This is a non-pivotal, randomized, two-arm, multi-center, prospective, non-significant risk study to evaluate the impact of the FreeStyle Libre 2 Flash Glucose Monitoring System compared to the current Diabetes Monitoring standard of care (SOC) on weight reduction in subjects with type 2 diabetes.
Subjects who have been diagnosed with type 2 diabetes will be randomized to use FreeStyle Libre 2 sensor (intervention arm) or their current standard of care (control arm) to manage their diabetes for a period of 6 months. Subjects will be asked to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at baseline (visit 1) and during visit 6. Subjects will also complete a separate subject questionnaire during visit 6.
All subjects will wear a FreeStyle Libre Pro sensor for enrollment (Screening) purposes and to collect baseline glycemic data prior to randomization. In addition, all subjects in both the intervention and control arms will wear an FSL Pro at days 75 and 165 for collection of glycemic endpoint data.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- FreeStyle Libre 2 Flash Glucose Monitoring System
- Keywords
- FreeStyle Libre
- 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 2 Flash Glucose Monitoring SystemDevice
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention will be administered. Subjects randomized to the Standard of Care Arm will continue using their Current standard of care device to monitor and manage their diabetes | |
| Intervention | Subjects randomized to this Arm will use FreeStyle Libre 2 to monitor and manage their diabetes. Receives: Device: FreeStyle Libre 2 Flash Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in bodyweight from the control arm at 6 months
Subjects' bodyweight will be measured during Visits 1, 3, 5 and 7. At the end of the 6 months period the bodyweight change, if any, will be assessed between the two Arms of the study.
Measured: six (6) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start5 Dec 2021
- Primary completion30 Jan 2023
- Study completion19 Jul 2023
Why it stopped: Slow enrollment and Study no longer required
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168306
- Sponsor's protocol ID
- ADC-US-RES-21215
- Status last verified
- Jan 2023
- First submitted
- 20 Dec 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
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 the Impact of the FreeStyle Libre 2 Flash Glucose Monitoring System, Compared to the Current Standard of Care (SOC), on Weight Reduction in Subjects With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT05168306
- Acronym / sponsor ID
- ADC-US-RES-21215
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- FreeStyle Libre
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrollment and Study no longer required
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2021 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 23 Dec 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.
To compare the impact of the FreeStyle Libre (FSL) 2 Flash Glucose Monitoring System to the current Diabetes Monitoring standard of care (SOC) on weight reduction in subjects with type 2 diabetes.
Detailed description
This is a non-pivotal, randomized, two-arm, multi-center, prospective, non-significant risk study to evaluate the impact of the FreeStyle Libre 2 Flash Glucose Monitoring System compared to the current Diabetes Monitoring standard of care (SOC) on weight reduction in subjects with type 2 diabetes.
Subjects who have been diagnosed with type 2 diabetes will be randomized to use FreeStyle Libre 2 sensor (intervention arm) or their current standard of care (control arm) to manage their diabetes for a period of 6 months. Subjects will be asked to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at baseline (visit 1) and during visit 6. Subjects will also complete a separate subject questionnaire during visit 6.
All subjects will wear a FreeStyle Libre Pro sensor for enrollment (Screening) purposes and to collect baseline glycemic data prior to randomization. In addition, all subjects in both the intervention and control arms will wear an FSL Pro at days 75 and 165 for collection of glycemic endpoint data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | – | –No intervention will be administered. Subjects randomized to the Standard of Care Arm will continue using their Current standard of care device to monitor and manage their diabetes |
| Intervention | – | Device: FreeStyle Libre 2 Flash Glucose Monitoring SystemSubjects randomized to this Arm will use FreeStyle Libre 2 to monitor and manage their diabetes. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have been diagnosed with type 2 diabetes
Key inclusion criteria (10 listed)
- Subject must be at least 30 years of age and no more than 70 years of age at the time of enrollment.
- Subject must have laboratory-based HbA1c measurement of between 8.0% and 10.0%.
- Subject has 25% or more time spent above 180 mg/dL between the hours of 6am and 10pm during the screening phase.
- Subject has a Body Mass Index (BMI) of 30 or greater.
- Subject must have had a diagnosis of type 2 diabetes.
Key exclusion criteria (22 listed)
- Subject is unable to perform mild physical activity (i.e. walking, stationary bike, etc.) for a minimum of 20 minutes per day.
- Subject has used an unblinded continuous glucose monitor in the three (3) months prior to enrollment.
- Subject is currently on any form of insulin therapy.
- Subject is currently on a low carbohydrate diet.
- Subject is currently using a commercial structured-meal weight loss program (i.e. Nutrisystem)
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 2 Flash Glucose Monitoring SystemThe FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. | Device | Intervention |
Primary outcome
Difference in bodyweight from the control arm at 6 months
Time frame: six (6) months
Subjects' bodyweight will be measured during Visits 1, 3, 5 and 7. At the end of the 6 months period the bodyweight change, if any, will be assessed between the two Arms of the study.
Results and safety
The study was stopped early (reason given: Slow enrollment and Study no longer required). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- 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
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 Diabetes Mellitus, Type 2, 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 10 inclusion and 22 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: stopped early, 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 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?
The study was stopped early (reason given: Slow enrollment and Study no longer required). 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?
Difference in bodyweight from the control arm at 6 months (time frame: six (6) months). 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 30 Jan 2025; AzTrials last refreshed its copy on 28 Oct 2026.