HbA1c Variation Study

NCT ID: NCT05189938

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 488 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-20
• Study Completion Date: 2023-12-30

Brief Summary

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

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.

Conditions

Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Diabetes Care

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shridhara A Karinka, PhD

Role: STUDY_DIRECTOR

Abbott Diabetes Care

Locations

Excellence Research and Medical

Miami Gardens, Florida, United States

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Billings Clinic

Billings, Montana, United States

Albuquerque Neuroscience Inc.

Albuquerque, New Mexico, United States

Anmed Health Internal Medicine Associates

Anderson, South Carolina, United States

Prime Revival Research Institute

Flower Mound, Texas, United States

Eastside Research Associates

Redmond, Washington, United States

Rainier Clinical Research Center

Renton, Washington, United States

University Hospital Birmingham

Birmingham, , United Kingdom

Bradford Royal Infirmary

Bradford, , United Kingdom

Royal Derby Hospital

Derby, , United Kingdom

Edinburgh Royal Infirmary

Edinburgh, , United Kingdom

Northwick Park Hospital

Harrow, , United Kingdom

Hull Royal Infirmary

Hull, , United Kingdom

St James University Hospital

Leeds, , United Kingdom

Leicester General Hospital

Leicester, , United Kingdom

Manchester Royal Infirmary

Manchester, , United Kingdom

Nottingham Children's Hospital & Queen's Medical Centre

Nottingham, , United Kingdom

Royal Berkshire Hospital

Reading, , United Kingdom

Northern General Hospital

Sheffield, , United Kingdom

Ealing Hospital

Southall, , United Kingdom

The Royal London Hospital

Whitechapel, , United Kingdom

Countries

United States; United Kingdom

Other Identifiers

ADC-US-RES-21212

Identifier Type: -

Identifier Source: org_study_id