HbA1c Variation Study
1 other identifier
observational
488
2 countries
22
Brief Summary
To evaluate the relationship between glycated hemoglobin (HbA1c) and average glucose levels using continuous glucose monitoring.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Typical duration for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2021
CompletedStudy Start
First participant enrolled
December 20, 2021
CompletedFirst Posted
Study publicly available on registry
January 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedMay 25, 2025
May 1, 2025
2 years
December 20, 2021
May 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Establish a relationship between laboratory-derived HbA1c and average glucose levels
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.
six (6) months
Interventions
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.
Eligibility Criteria
Subjects with type 1 or 2 diabetes.
You may qualify if:
- Subject must have type 1 or type 2 diabetes.
- Subject is at least 4 years old.
- Point-of-care (POC) HbA1C of 3.0%-15.5% (9 mmol/mol - 146 mmol/mol)
- 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.
- Subjects age 4 - 17: Parent or guardian must be willing and able to provide written signed and dated informed consent.
- Subjects age 11 - 17 Subject must be willing and able to provide written signed and dated informed assent.
You may not qualify if:
- Subject is currently undergoing dialysis or planning to receive dialysis during the course of the study
- History of blood transfusion in the last 3 months or planned blood transfusion during the course of the study.
- 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.
- Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- 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).
- 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 has a pacemaker or any other neurostimulators.
- 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.
- Subject is currently participating in another interventional clinical trial.
- Subject is unsuitable for participation due to any other cause as determined by the Investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Excellence Research and Medical
Miami Gardens, Florida, 33169, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404, United States
Billings Clinic
Billings, Montana, 59101, United States
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, 87109, United States
Anmed Health Internal Medicine Associates
Anderson, South Carolina, 29621, United States
Prime Revival Research Institute
Flower Mound, Texas, 75028, United States
Eastside Research Associates
Redmond, Washington, 98052, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
University Hospital Birmingham
Birmingham, B9 5PU, United Kingdom
Bradford Royal Infirmary
Bradford, BD9 6RJ, United Kingdom
Royal Derby Hospital
Derby, DE22 3NE, United Kingdom
Edinburgh Royal Infirmary
Edinburgh, EH1 3EG, United Kingdom
Northwick Park Hospital
Harrow, HA1 3UJ, United Kingdom
Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
St James University Hospital
Leeds, LS9 7TF, United Kingdom
Leicester General Hospital
Leicester, LE1 5WW, United Kingdom
Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
Nottingham Children's Hospital & Queen's Medical Centre
Nottingham, NG7 2UH, United Kingdom
Royal Berkshire Hospital
Reading, RG1 5AN, United Kingdom
Northern General Hospital
Sheffield, S10 2SB, United Kingdom
Ealing Hospital
Southall, UB1 3HW, United Kingdom
The Royal London Hospital
Whitechapel, E1 1FR, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shridhara A Karinka, PhD
Abbott Diabetes Care
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2021
First Posted
January 13, 2022
Study Start
December 20, 2021
Primary Completion
December 30, 2023
Study Completion
December 30, 2023
Last Updated
May 25, 2025
Record last verified: 2025-05