Type 1 DiabetesNCT02073058
Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System
An observational study of Type 1 Diabetes and Type 2 Diabetes, run by Abbott Diabetes Care at 4 sites in United States.
Trial summary
The purpose of this study is to demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring (GM) System interstitial glucose results against Reader capillary Blood Glucose (BG) reference using the Consensus Error Grid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- No treatment
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2014to May 2014
- 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 who require multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII). No more than 20 subjects will have HbA1c > 8.5%, and no more than 20 subjects will have HbA1c < 7% based on the subject screening.
Who may be able to join
- Subject must be at least 18 years of age.
- Subject must have type 1 or type 2 diabetes for at least 2 years prior to enrollment.
- Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily) for at least 6 months prior to enrollment.
- 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 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, attempting to conceive or 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 donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
- Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff. Such conditions include but are not limited to:
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- History of HIV, Hepatitis B or C
- Subject has a known medical condition that, in the opinion of the investigator, may increase the risk of bleeding.
- 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.
- Subject is unsuitable for participation due to any other cause as determined by the Investigator.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
AMCR Institute
Escondido, California, 92026
Rainier Clinical Research Center
Renton, Washington, 98057
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
The purpose of this study is to demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring (GM) System interstitial glucose results against Reader capillary Blood Glucose (BG) reference using the Consensus Error Grid. During the course of the wear duration, the subject is required to test fingerstick glucose measurement at least eight (8) times a day for capillary reference glucose measurements and three in-clinic visits of a maximum 13 hours each for venous reference glucose measurements. With every reference measurement, the subject or study staff will perform a measurement on the System.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- No treatment
- Keywords
- Subjects with Type 1 or Type 2 Diabetes Requiring Multiple daily Insulin Injection (MDI) or Continuous Subcutaneous Insulin Infusion (CSII)
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatmentDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical point accuracy as assessed by the Consensus Error Grid
Measured: 14 days
Secondary outcomes (3)
Safety endpoints that include signs and symptoms related to sensor application site
Measured: 14 days
Composite measure: Technical point accuracy (difference measures, Bland-Altman analysis, regression and percentage within ranges of the reference)
Measured: 14 days
Composite measure: Clinical point accuracy (Clarke Error Grid), trend accuracy (R-deviation, Rate Error Grid and Continuous Glucose Error Grid) and lag time, performance of notifications (sensitivity and false notifications) and questionnaire responses.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2014
- Study completionMay 2014
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 Type 1 DiabetesStudies 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Bailey, MD, Principal investigator, AMCR InstituteBruce Bode, MD, Principal investigator, Atlanta Diabetes AssociatesMark Christiansen, MD, Principal investigator, Diablo Clinical ResearchLeslie Klaff, MD, Principal investigator, Rainier Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073058
- Sponsor's protocol ID
- ADC-US-VAL-13128
- Status last verified
- May 2014
- First submitted
- 24 Feb 2014
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bailey T, Bode BW, Christiansen MP, Klaff LJ, Alva S. The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System. Diabetes Technol Ther. 2015 Nov;17(11):787-94. doi: 10.1089/dia.2014.0378. Epub 2015 Jul 14.
PubMed 26171659
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System
- ClinicalTrials.gov ID
- NCT02073058
- Acronym / sponsor ID
- ADC-US-VAL-13128
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Keywords
- Subjects with Type 1 or Type 2 Diabetes Requiring Multiple daily Insulin Injection (MDI) or Continuous Subcutaneous Insulin Infusion (CSII)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 27 Feb 2014 (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.
The purpose of this study is to demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring (GM) System interstitial glucose results against Reader capillary Blood Glucose (BG) reference using the Consensus Error Grid. During the course of the wear duration, the subject is required to test fingerstick glucose measurement at least eight (8) times a day for capillary reference glucose measurements and three in-clinic visits of a maximum 13 hours each for venous reference glucose measurements. With every reference measurement, the subject or study staff will perform a measurement on the System.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 who require multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII). No more than 20 subjects will have HbA1c > 8.5%, and no more than 20 subjects will have HbA1c < 7% based on the subject screening.
Key inclusion criteria (7 listed)
- Subject must be at least 18 years of age.
- Subject must have type 1 or type 2 diabetes for at least 2 years prior to enrollment.
- Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily) for at least 6 months prior to enrollment.
- 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.
Key exclusion criteria (10 listed)
- 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 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 donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
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 |
|---|---|---|
| No treatment | Device | – |
Primary outcome
Clinical point accuracy as assessed by the Consensus Error Grid
Time frame: 14 days
3 secondary outcomes
Safety endpoints that include signs and symptoms related to sensor application site
Time frame: 14 days
Composite measure: Technical point accuracy (difference measures, Bland-Altman analysis, regression and percentage within ranges of the reference)
Time frame: 14 days
Composite measure: Clinical point accuracy (Clarke Error Grid), trend accuracy (R-deviation, Rate Error Grid and Continuous Glucose Error Grid) and lag time, performance of notifications (sensitivity and false notifications) and questionnaire responses.
Time frame: 14 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 23 May 2014.
- Derived from this study: PubMed 26171659Bailey T, Bode BW, Christiansen MP, Klaff LJ, Alva S. The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System. Diabetes Technol Ther. 2015 Nov;17(11):787-94. doi: 10.1089/dia.2014.0378. Epub 2015 Jul 14.
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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.
Timothy Bailey, MD principal investigator
AMCR Institute
Bruce Bode, MD principal investigator
Atlanta Diabetes Associates
Mark Christiansen, MD principal investigator
Diablo Clinical Research
4 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 1 Diabetes and Type 2 Diabetes, 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 10 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 23 May 2014. 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?
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?
Clinical point accuracy as assessed by the Consensus Error Grid (time frame: 14 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 NCT02073058, 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 23 May 2014.