Diabetes MellitusNCT03607448
Freestyle Libre Flash Glucose Monitoring System
An observational study of Diabetes Mellitus, run by Abbott Diabetes Care at 5 sites in United States.
Trial summary
The purpose of this study is to characterize the Freestyle Libre Flash Glucose Monitoring System performance with respect to YSI reference venous plasma sample measurements. 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?
- Freestyle Libre Flash Glucose Monitoring System
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 153 participants
- Where
- 5 sitesUnited States
- Study dates
- 23 Jul 2018to 21 Nov 2018
- 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: Subjects with Type 1 or Type 2 diabetes requiring multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII).
Who may be able to join
- Subject must be at least 18 years of age.
- Subject must have type 1 or type 2 diabetes.
- Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily).
- Willing to perform a minimum of 8 finger sticks per day while wearing the sensor in the study.
- Subject must be able to read and understand English.
- Willing to have their blood sugar manipulated during in-clinic sessions.
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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.
- At the time of enrollment, subject must be available to participate in all study visits.
- Subject must be willing and able to provide written signed and dated informed consent.
- Additional criteria for hypoglycemia induction.
- Known insulin sensitivity factor.
Who cannot join
- Subject has a history of hypoglycemia unawareness.
- 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 has had an episode of severe hypoglycemia requiring intervention from a health care professional (i.e. EMT assistance, emergency room visit, or hospital admission) within the last three (3) months.
- Subject is currently participating in another clinical trial.
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- Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
- Subject has both hemoglobin (Hb) and hematocrit levels that are 10% or more below the normal ranges (For reference low end of the normal range for Hb for males is 14 g/dL and for females is 12 g/dL; low end of the normal hematocrit is 40% for men and 36% for women).
- 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. Such conditions include but are not limited to:
- History of HIV, Hepatitis B or C
- Subject has X-ray, MRI, CT or diathermy appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends.
- 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
AMCR
Escondido, California, 92025
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 94502
Rainier Clinical Research Center
Renton, Washington, 98057
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
Official title: Freestyle Libre Flash Glucose Monitoring System Accuracy Study
The purpose of this study is to characterize the Freestyle Libre Flash Glucose Monitoring System performance with respect to YSI reference venous plasma sample measurements.
Read the detailed description
Up to 200 subjects will be enrolled in this study at a total of 6 clinical research sites in the United States. Subjects will wear a total of two (2) sensors, one on the back of each upper arm. Each Sensor will have a paired Reader that will be given to the subject. All Readers will be masked during the study (i.e. subjects will not be able to view glucose results obtained from the Sensor on the Reader screen). Subjects will be asked to perform at least 8 capillary Blood Glucose (BG) tests per day using the primary Reader. Interstitial glucose readings from each Sensor will be obtained with the corresponding Readers immediately following each BG test. Subjects will be instructed to report any problems with the device. Subjects will make six (6) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Subjects will have three (3) in-clinic visits during which intravenous blood draws and YSI reference testing will occur.
- Conditions
- Diabetes Mellitus
- Being tested
- Freestyle Libre Flash Glucose Monitoring 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.
Freestyle Libre Flash Glucose Monitoring SystemDevice
Subjects will wear the Abbott Sensor based FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Mellitus Type 1 and Type 2 | Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and expected to perform at least 8 capillary BG test per day. Site Staff will determine when subject will undergo either a hypoglycemia induction or a hyperglycemia induction. Study staff will perform IV blood draw to obtain blood plasma for YSI sampling every 15 min when glucose as measured by YSI is above 70mg/dL and below 240 mg/dL. Receives: Device: Freestyle Libre Flash Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Performance
System Performance will be characterized with respect to YSI reference venous plasma measurements
Measured: approximately 45 days
Secondary outcomes (1)
System Related Adverse Device Effects
System will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants
Measured: Up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start23 Jul 2018
- Primary completion21 Nov 2018
- Study completion21 Nov 2018
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 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
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shridhara Karinka, PhD, Study director, Abbott Diabetes Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607448
- Sponsor's protocol ID
- ADC-US-VAL-18174
- Status last verified
- Nov 2018
- First submitted
- 27 Jul 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Alva S, Bailey T, Brazg R, Budiman ES, Castorino K, Christiansen MP, Forlenza G, Kipnes M, Liljenquist DR, Liu H. Accuracy of a 14-Day Factory-Calibrated Continuous Glucose Monitoring System With Advanced Algorithm in Pediatric and Adult Population With Diabetes. J Diabetes Sci Technol. 2022 Jan;16(1):70-77. doi: 10.1177/1932296820958754. Epub 2020 Sep 19.
PubMed 32954812
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Freestyle Libre Flash Glucose Monitoring System Accuracy Study
- ClinicalTrials.gov ID
- NCT03607448
- Acronym / sponsor ID
- ADC-US-VAL-18174
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 31 Jul 2018 (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 purpose of this study is to characterize the Freestyle Libre Flash Glucose Monitoring System performance with respect to YSI reference venous plasma sample measurements.
Detailed description
Up to 200 subjects will be enrolled in this study at a total of 6 clinical research sites in the United States. Subjects will wear a total of two (2) sensors, one on the back of each upper arm. Each Sensor will have a paired Reader that will be given to the subject. All Readers will be masked during the study (i.e. subjects will not be able to view glucose results obtained from the Sensor on the Reader screen). Subjects will be asked to perform at least 8 capillary Blood Glucose (BG) tests per day using the primary Reader. Interstitial glucose readings from each Sensor will be obtained with the corresponding Readers immediately following each BG test. Subjects will be instructed to report any problems with the device. Subjects will make six (6) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Subjects will have three (3) in-clinic visits during which intravenous blood draws and YSI reference testing will occur.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes Mellitus Type 1 and Type 2 | – | Device: Freestyle Libre Flash Glucose Monitoring SystemSubjects will wear the Abbott Sensor Based Glucose Monitoring Systems and expected to perform at least 8 capillary BG test per day. Site Staff will determine when subject will undergo either a hypoglycemia induction or a hyperglycemia induction. Study staff will perform IV blood draw to obtain blood plasma for YSI sampling every 15 min when glucose as measured by YSI is above 70mg/dL and below 240 mg/dL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with Type 1 or Type 2 diabetes requiring multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII).
Key inclusion criteria (11 listed)
- Subject must be at least 18 years of age.
- Subject must have type 1 or type 2 diabetes.
- Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily).
- Willing to perform a minimum of 8 finger sticks per day while wearing the sensor in the study.
- Subject must be able to read and understand English.
Key exclusion criteria (12 listed)
- Subject has a history of hypoglycemia unawareness.
- 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 has had an episode of severe hypoglycemia requiring intervention from a health care professional (i.e. EMT assistance, emergency room visit, or hospital admission) within the last three (3) months.
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 Flash Glucose Monitoring SystemSubjects will wear the Abbott Sensor based FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes | Device | Diabetes Mellitus Type 1 and Type 2 |
Primary outcome
System Performance
Time frame: approximately 45 days
System Performance will be characterized with respect to YSI reference venous plasma measurements
1 secondary outcome
System Related Adverse Device Effects
Time frame: Up to 45 days
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 29 Nov 2018.
- Derived from this study: PubMed 32954812Alva S, Bailey T, Brazg R, Budiman ES, Castorino K, Christiansen MP, Forlenza G, Kipnes M, Liljenquist DR, Liu H. Accuracy of a 14-Day Factory-Calibrated Continuous Glucose Monitoring System With Advanced Algorithm in Pediatric and Adult Population With Diabetes. J Diabetes Sci Technol. 2022 Jan;16(1):70-77. doi: 10.1177/1932296820958754. Epub 2020 Sep 19.
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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 Karinka, PhD study director
Abbott Diabetes Care
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 12 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 29 Nov 2018. 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?
System Performance (time frame: approximately 45 days). 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 NCT03607448, 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 29 Nov 2018.