Type 2 Diabetes MellitusNCT02336945
Glucose Variability Pilot Study for the Abbott Sensor Based Glucose Monitoring System-Professional
An observational study of Type 2 Diabetes Mellitus, run by Abbott Diabetes Care at 7 sites in United States.
Trial summary
This is a multi-center, prospective, non-pivotal, single arm, non-significant risk evaluation the Abbott Sensor Based Glucose Monitoring System - Pro across different stages of T2 diabetes management. This is a non-significant risk study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Abbott Sensor Based Glucose Monitoring System-Professional
- Type of treatment
- Medical device
- How many people
- 146 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2015to Jul 2015
- 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 2 diabetes who meet one of the therapy groups
Who may be able to join
- Subject must be at least 18 years of age.
- Subject must have diagnosis of type 2 diabetes prior to enrollment.
- Subject must have been on current treatment regimen for at least 6 months prior to enrollment and must remain on therapy regimen for the duration of the study (subjects diagnosed within last 6 months must be on no medication both prior to and throughout the study to enroll).
- HbA1c greater than or equal to 6.0% or less than or equal to 12.0% as demonstrated by lab HbA1c result obtained within the last 6 months.
- Subjects with HbA1c <7.5% will be excluded from the study if the subject's intended therapy group for enrollment requires an HbA1c ≥7.5%.
- For therapy groups enrolling 12 subjects with HbA1c of <7.5% and 12 subjects with HbA1c of ≥7.5%, subjects with an HbA1c level within each respective range will be excluded from the study once the enrollment goal of that HbA1c range has been met.
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- If no HbA1c taken within the last six months is available, a new laboratory HbA1c value must be obtained prior to Sensor application.
- 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
- In the investigators opinion, the subject must be compliant with their diabetes management plan and must be able to adhere to medication regimen throughout study.
- 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 has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Subject is pregnant, is attempting to conceive or is not willing and able to practice birth control during the study duration (applicable to female subjects only).
- Subject has skin lesions, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
- Subject currently is participating in another clinical trial.
- Subject has X-ray, MRI or CT 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.
- HbA1c of less than 6.0% or greater than 12.0% as demonstrated by lab HbA1c result obtained within the last 6 months.
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- Enrollment goal of Subject's intended therapy group has been met.
- Subject is unsuitable for participation due to any other cause as determined by the Investigator.
- Subject is currently on one of the following treatments or treatment combinations:
- Metformin + Sulfonylurea + DPP-4 Inhibitor
- Sulfonylurea + DPP-4 Inhibitor
- Metformin + Sulfonylurea + GLP-1 Receptor Agonist
- Sulfonylurea + GLP-1 Receptor Agonist
- Metformin + Sulfonylurea + SGLT-2
- Sulfonylurea + SGLT-2
- Metformin + SGLT-2 + Insulin
- SGLT-2 + Insulin
- NPH Insulin (with exception of NPH insulin present in premix formulations)
- Rapid acting insulin (with exception of rapid acting insulin present in premix formulations)
- Four (4) or more diabetes therapies
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Unger Primary Care Medical Center & Catalina Research Institute
Chino, California, 91710
Henry Ford Medical Center
Detroit, Michigan, 48202
Duke Southern Regional AHEC
Fayetteville, North Carolina, 28304
St. Luke's Endocrinology and Diabetes
Kansas City, Missouri, 64111
Dr. Deanna Cheung
Long Beach, California, 90807
Diabetes America- Pearland
Pearland, Texas, 77584
University of California San Diego Veterns Affairs Medical Center
San Diego, California, 92161
About this study
This is a multi-center, prospective, non-pivotal, single arm, non-significant risk evaluation the Abbott Sensor Based Glucose Monitoring System - Pro across different stages of T2 diabetes management. This is a non-significant risk study.
Read the detailed description
Subjects will wear two Sensors, one applied to the back of each upper arm, for a period of 14 days. Subjects will wear the Sensor while going about their normal daily activities during the home use period. Subjects will not be able to see any glucose data. The devices will be removed at the completion of the final study visit.
Data obtained from the Reader and reports generated by the system will not be used by the subject or the research team members to determine treatment. Subjects must adhere to their diabetes clinical management plan established prior to the study.
No additional medical care will be provided to study subjects following study completion other than care related to the follow up and treatment of adverse events.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Abbott Sensor Based Glucose Monitoring System-Professional
- 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.
Abbott Sensor Based Glucose Monitoring System-ProfessionalDevice
Also called FreeStyle Libre Pro
Subjects will wear 2 glucose sensors while going about daily activities and adhering to establish diabetes treatment plan. This is not a treatment study.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes | Subjects with type 2 diabetes who meet one of the therapy conditions Receives: Device: Abbott Sensor Based Glucose Monitoring System-Professional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose variability as measured by AGP Interquartile Range, (IQR) obtained via System-Pro Sensor.
Measured: 2 weeks
Secondary outcomes (1)
Assessment of ambulatory glucose profiles (AGPs) generated by the Software
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336945
- Sponsor's protocol ID
- ADC-US-RES-14137
- Status last verified
- Aug 2015
- First submitted
- 9 Jan 2015
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Variability Pilot Study for the Abbott Sensor Based Glucose Monitoring System-Professional
- ClinicalTrials.gov ID
- NCT02336945
- Acronym / sponsor ID
- ADC-US-RES-14137
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Jan 2015 (estimated)
- 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.
This is a multi-center, prospective, non-pivotal, single arm, non-significant risk evaluation the Abbott Sensor Based Glucose Monitoring System - Pro across different stages of T2 diabetes management. This is a non-significant risk study.
Detailed description
Subjects will wear two Sensors, one applied to the back of each upper arm, for a period of 14 days. Subjects will wear the Sensor while going about their normal daily activities during the home use period. Subjects will not be able to see any glucose data. The devices will be removed at the completion of the final study visit.
Data obtained from the Reader and reports generated by the system will not be used by the subject or the research team members to determine treatment. Subjects must adhere to their diabetes clinical management plan established prior to the study.
No additional medical care will be provided to study subjects following study completion other than care related to the follow up and treatment of adverse events.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes | – | Device: Abbott Sensor Based Glucose Monitoring System-ProfessionalSubjects with type 2 diabetes who meet one of the therapy conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with type 2 diabetes who meet one of the therapy groups
Key inclusion criteria (12 listed)
- Subject must be at least 18 years of age.
- Subject must have diagnosis of type 2 diabetes prior to enrollment.
- Subject must have been on current treatment regimen for at least 6 months prior to enrollment and must remain on therapy regimen for the duration of the study (subjects diagnosed within last 6 months must be on no medication both prior to and throughout the study to enroll).
- HbA1c greater than or equal to 6.0% or less than or equal to 12.0% as demonstrated by lab HbA1c result obtained within the last 6 months.
- Subject must be able to read and understand English.
Key exclusion criteria (20 listed)
- Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Subject is pregnant, is attempting to conceive or is not willing and able to practice birth control during the study duration (applicable to female subjects only).
- Subject has skin lesions, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
- Subject currently is participating in another clinical trial.
- Subject has X-ray, MRI or CT 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.
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 |
|---|---|---|
| Abbott Sensor Based Glucose Monitoring System-ProfessionalAlso: FreeStyle Libre ProSubjects will wear 2 glucose sensors while going about daily activities and adhering to establish diabetes treatment plan. This is not a treatment study. | Device | Type 2 diabetes |
Primary outcome
Glucose variability as measured by AGP Interquartile Range, (IQR) obtained via System-Pro Sensor.
Time frame: 2 weeks
1 secondary outcome
Assessment of ambulatory glucose profiles (AGPs) generated by the Software
Time frame: 2 weeks
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 24 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by Abbott Diabetes Care at 7 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 12 inclusion and 20 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 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Glucose variability as measured by AGP Interquartile Range, (IQR) obtained via System-Pro Sensor. (time frame: 2 weeks). 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 24 Jan 2017.