Diabetes MellitusNCT04604093
Effect of the FreeStyle Libre 2 Flash Glucose Monitoring System on Hyperglycemia in People With T2 Diabetes
An observational study of Diabetes Mellitus, run by Abbott Diabetes Care at 5 sites in United States.
Trial summary
A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre 2 Flash Glucose Monitoring System to the current standard of care (SMBG, self-monitoring of blood glucose) on reducing time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled… 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?
- SMBG Meter and FreeStyle Libre 2 System
- Type of treatment
- Medical device
- How many people
- 358 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Oct 2020to 30 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects with type 2 diabetes diagnosis currently on oral anti-diabetes medication(s).
Who may be able to join
- Subject must be at least 18 years of age.
- Subject must have HbA1c of > 7.5% at screening
- Subject has 35% or more time spent above 180 mg/dL during the screening phase.
- Subject must have had a diagnosis of type 2 diabetes for at least six (6) months prior to enrollment.
- Subject has been prescribed at least one capillary blood test every day for self-management of blood glucose (SMBG) to manage their diabetes.
- Subject must be on at least one (1) oral anti-diabetes medication.
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- Subject must be able to read and understand English.
- 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 currently on any form of insulin therapy.
- Subject has used an unblinded continuous glucose monitor (CGM) in the 3 months prior to enrollment.
- 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. 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 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.
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- 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Billings Clinic
Billings, Montana, 59101
Valley Research
Fresno, California, 93720
Palm Research Center
Las Vegas, Nevada, 89148
CEDE (Center of Excellence in Diabetes and Endocrinology)
Sacramento, California, 95821
Metabolic Research Institute
West Palm Beach, Florida, 33401
About this study
Official title: Use of the FreeStyle Libre 2 Flash Glucose Monitoring System to Reduce Hyperglycemia in People With T2 Diabetes
A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre 2 Flash Glucose Monitoring System to the current standard of care (SMBG, self-monitoring of blood glucose) 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
Up to approximately 350 subjects will be enrolled to obtain a minimum of 130 randomized subjects, with a minimum of approximately 65 subjects per arm. At least 50% of randomized subjects will be age 65 and older. Subjects will be randomized to use either the FreeStyle Libre 2 Flash Glucose Monitoring System or traditional SMBG to manage their diabetes. The subsequent impact of FreeStyle Libre 2 versus SMBG on reducing the amount of time spent above 180 mg/dL will be assessed.
Safety of the FreeStyle Libre 2 Flash Glucose Monitoring System and SMBG will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.
- Conditions
- Diabetes Mellitus
- Being tested
- SMBG Meter, FreeStyle Libre 2 System
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMBG MeterDevice
Self Monitoring Blood Glucose Meter
FreeStyle Libre 2 SystemDevice
The Abbott's FreeStyle Libre 2 Flash Glucose Monitoring System
| Study group | Role | What they receive |
|---|---|---|
| SMBG, self-monitoring of blood glucose | Subjects will be randomized to continue use traditional SMBG, self-monitoring of blood glucose, to manage their diabetes. Receives: Device: SMBG Meter | |
| FreeStyle Libre 2 | Subjects will be randomized to use the FreeStyle Libre 2 Flash Glucose Monitoring System to manage their diabetes. Receives: Device: FreeStyle Libre 2 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on time above 180 mg/dL in subjects with type 2 diabetes
To assess the impact of the FreeStyle Libre 2 Flash Glucose Monitoring System on time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen when compared to the current standard of care (SMBG, self-monitoring of blood glucose).
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 posted27 Oct 2020
- Study start20 Oct 2020
- Primary completion28 Feb 2023
- Study completion30 Mar 2023
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
- 358 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 Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604093
- Sponsor's protocol ID
- ADC-US-RES-20193
- Status last verified
- Jul 2023
- First submitted
- 21 Oct 2020
- Last updated
- 21 Jul 2023
- 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 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the FreeStyle Libre 2 Flash Glucose Monitoring System to Reduce Hyperglycemia in People With T2 Diabetes
- ClinicalTrials.gov ID
- NCT04604093
- Acronym / sponsor ID
- ADC-US-RES-20193
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 27 Oct 2020 (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 2 Flash Glucose Monitoring System to the current standard of care (SMBG, self-monitoring of blood glucose) 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
Up to approximately 350 subjects will be enrolled to obtain a minimum of 130 randomized subjects, with a minimum of approximately 65 subjects per arm. At least 50% of randomized subjects will be age 65 and older. Subjects will be randomized to use either the FreeStyle Libre 2 Flash Glucose Monitoring System or traditional SMBG to manage their diabetes. The subsequent impact of FreeStyle Libre 2 versus SMBG on reducing the amount of time spent above 180 mg/dL will be assessed.
Safety of the FreeStyle Libre 2 Flash Glucose Monitoring System and SMBG will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMBG, self-monitoring of blood glucose | – | Device: SMBG MeterSubjects will be randomized to continue use traditional SMBG, self-monitoring of blood glucose, to manage their diabetes. |
| FreeStyle Libre 2 | – | Device: FreeStyle Libre 2 SystemSubjects will be randomized to use the FreeStyle Libre 2 Flash Glucose Monitoring System 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
- Adult subjects with type 2 diabetes diagnosis currently on oral anti-diabetes medication(s).
Key inclusion criteria (11 listed)
- Subject must be at least 18 years of age.
- Subject must have HbA1c of > 7.5% at screening
- Subject has 35% or more time spent above 180 mg/dL during the screening phase.
- Subject must have had a diagnosis of type 2 diabetes for at least six (6) months prior to enrollment.
- Subject has been prescribed at least one capillary blood test every day for self-management of blood glucose (SMBG) to manage their diabetes.
Key exclusion criteria (9 listed)
- Subject is currently on any form of insulin therapy.
- Subject has used an unblinded continuous glucose monitor (CGM) in the 3 months prior to enrollment.
- 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. 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.
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 |
|---|---|---|
| SMBG MeterSelf Monitoring Blood Glucose Meter | Device | SMBG, self-monitoring of blood glucose |
| FreeStyle Libre 2 SystemThe Abbott's FreeStyle Libre 2 Flash Glucose Monitoring System | Device | FreeStyle Libre 2 |
Primary outcome
Impact on time above 180 mg/dL in subjects with type 2 diabetes
Time frame: Six (6) months
To assess the impact of the FreeStyle Libre 2 Flash Glucose Monitoring System on time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen when compared to the current standard of care (SMBG, self-monitoring of blood glucose).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- 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
5 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 5 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 11 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: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in subjects with type 2 diabetes (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 21 Jul 2023.