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Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring Systems

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care
ClinicalTrials.gov Identifier:
NCT02283411
First received: October 31, 2014
Last updated: July 13, 2016
Last verified: July 2016
  Purpose

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 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.


Condition Intervention
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Device: Abbott Sensor Based Glucose Monitoring System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring System - Personal and Abbott Sensor Based Glucose Monitoring System - Professional

Resource links provided by NLM:


Further study details as provided by Abbott Diabetes Care:

Primary Outcome Measures:
  • 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. [ Time Frame: 14 days ]
  • 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. [ Time Frame: Safety will be evaluated throughout the subject's study participation, an expected average of 30 days. ]

Secondary Outcome Measures:
  • The trend accuracy of the device performance will be evaluated [ Time Frame: 14 days ]
  • The temporal System accuracy at different glucose rates of change and different glucose ranges (hypoglycemic, euglycemic, and hyperglycemic ranges) will be evaluated. [ Time Frame: 14 days ]
  • The point accuracy of the device performance will be evaluated in reference to capillary BG. [ Time Frame: 14 days ]

Enrollment: 156
Study Start Date: November 2014
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Diabetes Mellitus, Type 1 and Type 2
Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes.
Device: Abbott Sensor Based Glucose Monitoring System
Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject must be at least 18 years of age.
  2. Subject must have a diagnosis of type 1 or type 2 diabetes mellitus.
  3. 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)
  4. 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.
  5. 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.
  6. Willing to perform a minimum of 8 finger sticks per day during the study.
  7. Subject must be able to read and understand English.
  8. 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.
  9. Subject must be available to participate in all study visits.
  10. Subject must be willing and able to provide written signed and dated informed consent.

Exclusion Criteria:

  1. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
  2. 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).
  3. 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.
  4. Subject is on dialysis.
  5. 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.
  6. Subjects with a history of hypoglycemia unawareness, hypoglycemic seizures or unconsciousness.
  7. Subjects who have experienced diabetes-related complications requiring assistance from another person in the last six months.
  8. Subject currently is participating in another clinical trial.
  9. Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
  10. Subject is anemic.
  11. Subject does not have a known insulin to carbohydrate ratio at the time of enrollment (IIT subjects only).
  12. 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

  13. 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.
  14. Subject has an abnormal EKG, unless cleared for study participation by a cardiologist.
  15. Subject is unsuitable for participation due to any other cause as determined by the Investigator.

    Additional Criteria

  16. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02283411

Locations
United States, California
William Sansum Diabetes Center
Santa Barbara, California, United States, 93105
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
United States, Idaho
Rocky Mountain Diabetes & Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
United States, Texas
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
United States, Washington
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
Principal Investigator: Bruce Bode, MD Atlanta Diabetes Associates
Principal Investigator: Ronald Brazg, MD Rainier Clinical Research Center
Principal Investigator: Kristin Castorino, DO William Sansum Diabetes Center
Principal Investigator: Mark Christiansen, MD Diablo Clinical Research
Principal Investigator: Douglas Denham, DO Clinical Trials of Texas
Principal Investigator: David Liljenquist, MD Rocky Mountain Diabetes & Osteoporosis Center
  More Information

Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT02283411     History of Changes
Other Study ID Numbers: ADC-US-VAL-14135
Study First Received: October 31, 2014
Last Updated: July 13, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided to whether to make individual participant data available.

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 21, 2017