Diabetes Mellitus, Type 1NCT02283411
Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring Systems
A study testing Abbott Sensor Based Glucose Monitoring System in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Abbott Diabetes Care at 6 sites in United States.
Trial summary
The purpose of the study is to evaluate the safety and effectiveness of the Abbott Sensor Based Glucose Monitoring System Personal (System-P) and Abbott Sensor Based Glucose Monitoring System Professional (System-Pro) when used as an adjunct to blood glucose testing over a 14-day wear period in adult subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- Abbott Sensor Based Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be at least 18 years of age.
- Subject must have a diagnosis of type 1 or type 2 diabetes mellitus.
- Use one of the following for their diabetes management:
- intensive insulin therapy (insulin therapy through an insulin pump and/or multiple daily insulin injections) or
- non-intensive insulin therapy (Basal insulin, injectable non-insulin anti-diabetic agents such as a pramlintide or GLP-1 agonists, NPH insulin either alone or in combination with regular insulin or fast acting insulin analogue, or oral medication)
- Intensive-insulin using (IIT) subjects only - During one of the in-clinic sessions, subject is willing to have their blood glucose levels manipulated into high and low glucose levels. Insulin-to-carbohydrate ratio and insulin sensitivity formula must be documented prior to having blood glucose levels manipulated. NIT subjects will only be observed during each in-clinic session.
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- For subjects that exercise routinely (at least 3 times per week), willing to exercise during at least one of the in-clinic sessions, if asked.
- Willing to perform a minimum of 8 finger sticks per day during the study.
- 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, 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 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 on dialysis.
- Subject has a history of untreated hypothyroidism, adrenal gland failure or insufficiency, celiac disease, renal failure, cystic fibrosis, unstable coronary heart disease, or serious psychiatric disorders.
- Subjects with a history of hypoglycemia unawareness, hypoglycemic seizures or unconsciousness.
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- Subjects who have experienced diabetes-related complications requiring assistance from another person in the last six months.
- 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 is anemic.
- Subject does not have a known insulin to carbohydrate ratio at the time of enrollment (IIT subjects only).
- 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:
- History of HIV, Hepatitis B or C
- 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 has an abnormal EKG, unless cleared for study participation by a cardiologist.
- Subject is unsuitable for participation due to any other cause as determined by the Investigator.
- Additional Criteria
- The following subjects may participate in the study but will be excluded from all glycemic and exercise challenges:
- Subject's taking medications known to mask symptoms or hypoglycemia, such as beta blockers;
- Subjects with any of the following: clinically significant history of cardiovascular or cerebrovascular disease, cardiac arrhythmia, neurological disorders such as seizures, CVA, or syncope, or hypokalemia.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Rocky Mountain Diabetes & Osteoporosis Center
Idaho Falls, Idaho, 83404
Rainier Clinical Research Center
Renton, Washington, 98057
Clinical Trials of Texas
San Antonio, Texas, 78229
William Sansum Diabetes Center
Santa Barbara, California, 93105
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
Official title: Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring System - Personal and Abbott Sensor Based Glucose Monitoring System - Professional
The purpose of the study is to evaluate the safety and effectiveness of the Abbott Sensor Based Glucose Monitoring System Personal (System-P) and Abbott Sensor Based Glucose Monitoring System Professional (System-Pro) when used as an adjunct to blood glucose testing over a 14-day wear period in adult subjects. The Abbott Sensor Based Glucose Monitoring System - Professional Sensors will be worn by adult subjects over a 14-day wear period.
The primary objective is to characterize the Systems performance with respect to Yellow Spring Instrument (YSI) reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate accuracy of the Abbott Sensor Based Glucose Monitoring Systems in reference to YSI.
Read more
Safety of the Abbott Sensor Based Glucose Monitoring Systems will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.
240 subjects will be enrolled and additional healthy subjects may also be enrolled in the study as training subjects.
Read the detailed description
Sensors are inserted into the back of the subject's upper arm for up to fourteen (14) days. The subjects are expected to perform capillary BG tests during the 14-day sensor wear. Three in clinic visits are scheduled during the 14-day sensor wear period. During each in-clinic visit, study staff performed IV blood draws to obtain venous blood for YSI reference glucose measurements.
- Being tested
- Abbott Sensor Based Glucose Monitoring System
- 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.
Abbott Sensor Based Glucose Monitoring SystemDevice
Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Mellitus, Type 1 and Type 2 | Other | Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes. Receives: Device: Abbott Sensor Based Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Device Performance Was Evaluated in Terms of Point Accuracy of the Abbott Sensor Based Glucose Monitoring Systems in Reference to Yellow Spring Instrument (YSI).
Point accuracy of the system was evaluated as the proportion of System readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels <80 mg/dL. All 125 subjects wore both System-P and System-Pro Sensors and were included in the outcome measure. System P, the Personal System which is intended for single patient use and System Pro is intended for use by healthcare professionals (HCP). Each subject had up to 136 YSI samples collected during the study which were paired with sensor glucose readings measured at the same time. Point accuracy of the system was evaluated as the percentage of sensor glucose readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels <80 mg/dL.
Measured: 14 days
Safety of the Abbott Sensor Based Glucose Monitoring Systems Was Characterized by Adverse Device Effects and Serious Adverse Device Effects Experienced by Study Participants.
Safety of the Abbott Sensor Based Glucose Monitoring Systems, including adverse device effects and serious adverse device effects were assessed for all participants enrolled in the study.
Measured: Safety was evaluated throughout the subject's study participation.
Secondary outcomes (3)
The Trend Accuracy of the System P Device Performance Was Evaluated.
Trend accuracy of the device performance was assessed by comparing of the glucose rate of change results between the sensor glucose readings and YSI reference results for System P only.
Measured: 14 days
The Temporal System Accuracy at Different Glucose Rates of Change and Different Glucose Ranges (Hypoglycemic, Euglycemic, and Hyperglycemic Ranges) Was Evaluated.
The Continuous Glucose Error Grid Analysis (CG-EGA) in the Hypoglycemic range (YSI ≤ 70 mg/dL), in the Euglycemic range (70 < YSI ≤ 180 mg/dL) and in the Hyperglycemic range (YSI > 180 mg/dL) were evaluated.
Measured: 14 days
The Point Accuracy of the Device Performance Was Evaluated in Reference to Capillary Blood Glucose (BG).
Point accuracy of the system was evaluated as the proportion of System readings that are within ±20% of the capillary blood glucose (BG) value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for capillary blood glucose (BG) levels <80 mg/dL. All 125 subjects wore both System-P and System-Pro Sensors and were included in the outcome measure. System P, the Personal System which is intended for single patient use and System Pro is intended for use by healthcare professionals (HCP). Each subject had approximately112 capillary blood glucose (BG) samples collected during the study which were paired with sensor glucose readings measured at the same time. Point accuracy of the system was evaluated as the percentage of sensor glucose readings that are within ±20% of the BG value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for BG levels <80 mg/dL.
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 posted5 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Bode, MD, Principal investigator, Atlanta Diabetes AssociatesRonald Brazg, MD, Principal investigator, Rainier Clinical Research CenterKristin Castorino, DO, Principal investigator, Sansum Diabetes Research InstituteMark Christiansen, MD, Principal investigator, Diablo Clinical ResearchDouglas Denham, DO, Principal investigator, Clinical Trials of TexasDavid Liljenquist, MD, Principal investigator, Rocky Mountain Diabetes & Osteoporosis Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283411
- Sponsor's protocol ID
- ADC-US-VAL-14135
- Status last verified
- Jan 2018
- First submitted
- 31 Oct 2014
- Last updated
- 22 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Undecided to whether to make individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring System - Personal and Abbott Sensor Based Glucose Monitoring System - Professional
- ClinicalTrials.gov ID
- NCT02283411
- Acronym / sponsor ID
- ADC-US-VAL-14135
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Posted 22 Feb 2018
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 the study is to evaluate the safety and effectiveness of the Abbott Sensor Based Glucose Monitoring System Personal (System-P) and Abbott Sensor Based Glucose Monitoring System Professional (System-Pro) when used as an adjunct to blood glucose testing over a 14-day wear period in adult subjects. The Abbott Sensor Based Glucose Monitoring System - Professional Sensors will be worn by adult subjects over a 14-day wear period.
The primary objective is to characterize the Systems performance with respect to Yellow Spring Instrument (YSI) reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate accuracy of the Abbott Sensor Based Glucose Monitoring Systems in reference to YSI.
Safety of the Abbott Sensor Based Glucose Monitoring Systems will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.
240 subjects will be enrolled and additional healthy subjects may also be enrolled in the study as training subjects.
Detailed description
Sensors are inserted into the back of the subject's upper arm for up to fourteen (14) days. The subjects are expected to perform capillary BG tests during the 14-day sensor wear. Three in clinic visits are scheduled during the 14-day sensor wear period. During each in-clinic visit, study staff performed IV blood draws to obtain venous blood for YSI reference glucose measurements.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes Mellitus, Type 1 and Type 2 | Other | Device: Abbott Sensor Based Glucose Monitoring SystemSubjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject must be at least 18 years of age.
- Subject must have a diagnosis of type 1 or type 2 diabetes mellitus.
- Use one of the following for their diabetes management:
- Intensive-insulin using (IIT) subjects only - During one of the in-clinic sessions, subject is willing to have their blood glucose levels manipulated into high and low glucose levels. Insulin-to-carbohydrate ratio and insulin sensitivity formula must be documented prior to having blood glucose levels manipulated. NIT subjects will only be observed during each in-clinic session.
- For subjects that exercise routinely (at least 3 times per week), willing to exercise during at least one of the in-clinic sessions, if asked.
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 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 on dialysis.
- Subject has a history of untreated hypothyroidism, adrenal gland failure or insufficiency, celiac disease, renal failure, cystic fibrosis, unstable coronary heart disease, or serious psychiatric disorders.
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 SystemSubjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes. | Device | Diabetes Mellitus, Type 1 and Type 2 |
Primary outcome
The Device Performance Was Evaluated in Terms of Point Accuracy of the Abbott Sensor Based Glucose Monitoring Systems in Reference to Yellow Spring Instrument (YSI).
Time frame: 14 days
Point accuracy of the system was evaluated as the proportion of System readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels <80 mg/dL. All 125 subjects wore both System-P and System-Pro Sensors and were included in the outcome measure. System P, the Personal System which is intended for single patient use and System Pro is intended for use by healthcare professionals (HCP). Each subject had up to 136 YSI samples collected during the study which were paired with sensor glucose readings measured at the same time. Point accuracy of the system was evaluated as the percentage of sensor glucose readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels <80 mg/dL.
Safety of the Abbott Sensor Based Glucose Monitoring Systems Was Characterized by Adverse Device Effects and Serious Adverse Device Effects Experienced by Study Participants.
Time frame: Safety was evaluated throughout the subject's study participation.
Safety of the Abbott Sensor Based Glucose Monitoring Systems, including adverse device effects and serious adverse device effects were assessed for all participants enrolled in the study.
3 secondary outcomes
The Trend Accuracy of the System P Device Performance Was Evaluated.
Time frame: 14 days
The Temporal System Accuracy at Different Glucose Rates of Change and Different Glucose Ranges (Hypoglycemic, Euglycemic, and Hyperglycemic Ranges) Was Evaluated.
Time frame: 14 days
The Point Accuracy of the Device Performance Was Evaluated in Reference to Capillary Blood Glucose (BG).
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Undecided to whether to make individual participant data available.
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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.
Bruce Bode, MD principal investigator
Atlanta Diabetes Associates
Ronald Brazg, MD principal investigator
Rainier Clinical Research Center
Kristin Castorino, DO principal investigator
Sansum Diabetes Research Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abbott Sensor Based Glucose Monitoring System in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Abbott Diabetes Care at 6 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 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Yes. Results are posted in the registry (first posted 22 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Device Performance Was Evaluated in Terms of Point Accuracy of the Abbott Sensor Based Glucose Monitoring Systems in Reference to Yellow Spring Instrument (YSI). (time frame: 14 days). The study lists 2 primary outcomes in all. 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 22 Feb 2018.