HbA1c Variation Study

Last updated: May 23, 2025
Sponsor: Abbott Diabetes Care
Overall Status: Completed

Phase

N/A

Condition

Diabetes Prevention

Diabetes And Hypertension

Treatment

HBA1c data and glucose levels

Clinical Study ID

NCT05189938
ADC-US-RES-21212
  • Ages > 4
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 instructionsprovided to him/her by the study site and perform all study tasks as specified bythe 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 informedconsent.

  8. Subjects age 4 - 17: Parent or guardian must be willing and able to provide writtensigned and dated informed consent.

  9. Subjects age 11 - 17 Subject must be willing and able to provide written signed anddated informed assent.

Exclusion

Exclusion Criteria:

  1. Subject is currently undergoing dialysis or planning to receive dialysis during thecourse of the study

  2. History of blood transfusion in the last 3 months or planned blood transfusionduring the course of the study.

  3. Subject is currently planning to undergo a major medical intervention expected tosignificantly alter red cell life span, i.e. chemotherapy, major surgery requiringblood transfusions, etc.

  4. Subject has known allergy to medical grade adhesive or isopropyl alcohol used todisinfect skin.

  5. Subjects age 18 and older: Subject is known to be pregnant, attempting to conceiveor 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 knownto be pregnant at the time of study enrollment or is planning to become pregnantduring the study (applicable to female subjects only).

  6. Subject has extensive skin changes/diseases at the proposed application sites thatcould interfere with device placement or the accuracy of interstitial glucosemeasurements. Such conditions include, but are not limited to extensive psoriasis,recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitisherpetiformis, skin lesions, redness, infection or edema.

  7. Subject has a pacemaker or any other neurostimulators.

  8. 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.

  9. Subject is currently participating in another interventional clinical trial.

  10. Subject is unsuitable for participation due to any other cause as determined by theInvestigator.

Study Design

Total Participants: 488
Treatment Group(s): 1
Primary Treatment: HBA1c data and glucose levels
Phase:
Study Start date:
December 20, 2021
Estimated Completion Date:
December 30, 2023

Study 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.

Connect with a study center

  • University Hospital Birmingham

    Birmingham, B9 5PU
    United Kingdom

    Site Not Available

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ
    United Kingdom

    Site Not Available

  • Royal Derby Hospital

    Derby, DE22 3NE
    United Kingdom

    Site Not Available

  • Edinburgh Royal Infirmary

    Edinburgh, EH1 3EG
    United Kingdom

    Site Not Available

  • Northwick Park Hospital

    Harrow, HA1 3UJ
    United Kingdom

    Site Not Available

  • Hull Royal Infirmary

    Hull, HU3 2JZ
    United Kingdom

    Site Not Available

  • St James University Hospital

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • Leicester General Hospital

    Leicester, LE1 5WW
    United Kingdom

    Site Not Available

  • Manchester Royal Infirmary

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Nottingham Children's Hospital & Queen's Medical Centre

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • Royal Berkshire Hospital

    Reading, RG1 5AN
    United Kingdom

    Site Not Available

  • Northern General Hospital

    Sheffield, S10 2SB
    United Kingdom

    Site Not Available

  • Ealing Hospital

    Southall, UB1 3HW
    United Kingdom

    Site Not Available

  • The Royal London Hospital

    Whitechapel, E1 1FR
    United Kingdom

    Site Not Available

  • Excellence Research and Medical

    Miami Gardens, Florida 33169
    United States

    Site Not Available

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Billings Clinic

    Billings, Montana 59101
    United States

    Site Not Available

  • Albuquerque Neuroscience Inc.

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Anmed Health Internal Medicine Associates

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Prime Revival Research Institute

    Flower Mound, Texas 75028
    United States

    Site Not Available

  • Eastside Research Associates

    Redmond, Washington 98052
    United States

    Site Not Available

  • Rainier Clinical Research Center

    Renton, Washington 98057
    United States

    Site Not Available

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