HbA1c Variation Study

May 23, 2025 updated by: Abbott Diabetes Care
To evaluate the relationship between glycated hemoglobin (HbA1c) and average glucose levels using continuous glucose monitoring.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
488

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B9 5PU
        • University Hospital Birmingham
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • Derby, United Kingdom, DE22 3NE
        • Royal Derby Hospital
      • Edinburgh, United Kingdom, EH1 3EG
        • Edinburgh Royal Infirmary
      • Harrow, United Kingdom, HA1 3UJ
        • Northwick Park Hospital
      • Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary
      • Leeds, United Kingdom, LS9 7TF
        • St James University Hospital
      • Leicester, United Kingdom, LE1 5WW
        • Leicester General Hospital
      • Manchester, United Kingdom, M13 9WL
        • Manchester Royal Infirmary
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham Children's Hospital & Queen's Medical Centre
      • Reading, United Kingdom, RG1 5AN
        • Royal Berkshire Hospital
      • Sheffield, United Kingdom, S10 2SB
        • Northern General Hospital
      • Southall, United Kingdom, UB1 3HW
        • Ealing Hospital
      • Whitechapel, United Kingdom, E1 1FR
        • The Royal London Hospital
  • United States
    • Florida
      • Miami Gardens, Florida, United States, 33169
        • Excellence Research and Medical
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Clinical Research
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Albuquerque Neuroscience Inc.
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Anmed Health Internal Medicine Associates
    • Texas
      • Flower Mound, Texas, United States, 75028
        • Prime Revival Research Institute
    • Washington
      • Redmond, Washington, United States, 98052
        • Eastside Research Associates
      • Renton, Washington, United States, 98057
        • Rainier Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects with type 1 or 2 diabetes.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
six (6) months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Diabetes Care

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Shridhara A Karinka, PhD, Abbott Diabetes Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ADC-US-RES-21212

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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