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HbA1c Variation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05189938
Recruitment Status : Recruiting
First Posted : January 13, 2022
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care

Brief Summary:
To evaluate the relationship between glycated hemoglobin (HbA1c) and average glucose levels using continuous glucose monitoring.

Condition or disease Intervention/treatment
Diabetes Mellitus Diagnostic Test: HBA1c data and glucose levels

Detailed Description:
This is a non-pivotal , non-randomized, single-arm, multi-center, prospective, non-significant risk study to evaluate the relationship between glycated hemoglobin (HbA1c) and average glucose levels. Up to approximately 600 subjects will be enrolled who will have fourteen (14) study visits over the course of approximately six (6) months. During each visit the subject will have blood samples drawn for documentation of their HbA1c level. Subjects will also be required to wear Professional FreeStyle Libre Flash Glucose Monitoring System(s) to record blood glucose levels through the duration of the study. During Visits 1 and 14, Venous sample for CBC, biochemistry, haemoglobinopathy screen, hematology, liver function and iron panels will be collected.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HbA1c Variation Study
Actual Study Start Date : December 20, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Intervention Details:
  • Diagnostic Test: HBA1c data and glucose levels
    All subjects will wear the professional FreeStyle Libre Pro for glucose data and HbA1c data will be collected at different time points over the participation period.


Primary Outcome Measures :
  1. Establish a relationship between laboratory-derived HbA1c and average glucose levels [ Time Frame: six (6) months ]
    This is an observational data collection study, where the goal is to gather data to establish the relationship between laboratory-derived HbA1c and average glucose levels.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with type 1 or 2 diabetes.
Criteria

Inclusion Criteria:

  1. Subject must have type 1 or type 2 diabetes.
  2. Subject is at least 4 years old.
  3. Point-of-care (POC) HbA1C of 3.0%-15.5% (9 mmol/mol - 146 mmol/mol)
  4. Subject must be able to read and understand English.
  5. 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.
  6. Subject must be available to participate in all study visits.
  7. Subject must be willing and able to provide written signed and dated informed consent.
  8. Subjects age 4 - 17: Parent or guardian must be willing and able to provide written signed and dated informed consent.
  9. Subjects age 11 - 17 Subject must be willing and able to provide written signed and dated informed assent.

    Exclusion Criteria:

  10. Subject is currently undergoing dialysis or planning to receive dialysis during the course of the study
  11. History of blood transfusion in the last 3 months or planned blood transfusion during the course of the study.
  12. Subject is currently planning to undergo a major medical intervention expected to significantly alter red cell life span, i.e. chemotherapy, major surgery requiring blood transfusions, etc.
  13. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
  14. Subjects age 18 and older: Subject is known to be pregnant, attempting to conceive or is not willing and able to practice birth control during the study duration study (applicable to female subjects only). Subjects age 17 and younger: Subject is known to be pregnant at the time of study enrollment or is planning to become pregnant during the study (applicable to female subjects only).
  15. 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.
  16. Subject has a pacemaker or any other neurostimulators.
  17. 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.
  18. Subject is currently participating in another interventional clinical trial.
  19. Subject is unsuitable for participation due to any other cause as determined by the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05189938


Contacts
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Contact: Mohamed Nada, PhD 5107495416 ADC.Clinical@abbott.com

Locations
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United States, Montana
Billings Clinic Not yet recruiting
Billings, Montana, United States, 59101
Contact: Haleigh James, MD         
United States, Washington
Eastside Research Associates Recruiting
Redmond, Washington, United States, 98052
Contact: Kevin Hanson, MD         
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
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Study Director: Shridhara A Karinka, PhD Abbott Diabetes Care
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Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT05189938    
Other Study ID Numbers: ADC-US-RES-21212
First Posted: January 13, 2022    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abbott Diabetes Care:
Professional FreeStyle Libre Flash Glucose Monitoring System
HBA1C