Diabetes MellitusNCT05189938
HbA1c Variation Study
An observational study of Diabetes Mellitus, run by Abbott Diabetes Care at 22 sites in 2 countries.
Trial summary
To evaluate the relationship between glycated hemoglobin (HbA1c) and average glucose levels using continuous glucose monitoring. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- HBA1c data and glucose levels
- How many people
- 488 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 20 Dec 2021to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with type 1 or 2 diabetes.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United Kingdom14 sites
University Hospital Birmingham
Birmingham, B9 5PU
Bradford Royal Infirmary
Bradford, BD9 6RJ
Royal Derby Hospital
Derby, DE22 3NE
Edinburgh Royal Infirmary
Edinburgh, EH1 3EG
Northwick Park Hospital
Harrow, HA1 3UJ
Hull Royal Infirmary
Hull, HU3 2JZ
St James University Hospital
Leeds, LS9 7TF
Leicester General Hospital
Leicester, LE1 5WW
Manchester Royal Infirmary
Manchester, M13 9WL
Nottingham Children's Hospital & Queen's Medical Centre
Nottingham, NG7 2UH
Royal Berkshire Hospital
Reading, RG1 5AN
Northern General Hospital
Sheffield, S10 2SB
Ealing Hospital
Southall, UB1 3HW
The Royal London Hospital
Whitechapel, E1 1FR
United States8 sites
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, 87109
Anmed Health Internal Medicine Associates
Anderson, South Carolina, 29621
Billings Clinic
Billings, Montana, 59101
Prime Revival Research Institute
Flower Mound, Texas, 75028
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
Excellence Research and Medical
Miami Gardens, Florida, 33169
Eastside Research Associates
Redmond, Washington, 98052
Rainier Clinical Research Center
Renton, Washington, 98057
About this study
To evaluate the relationship between glycated hemoglobin (HbA1c) and average glucose levels using continuous glucose monitoring.
Read the 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
- Being tested
- HBA1c data and glucose levels
- Keywords
- Professional FreeStyle Libre Flash Glucose Monitoring System, HBA1C
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBA1c data and glucose levelsDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six (6) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start20 Dec 2021
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shridhara A Karinka, PhD, Study director, Abbott Diabetes Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189938
- Sponsor's protocol ID
- ADC-US-RES-21212
- Status last verified
- May 2025
- First submitted
- 20 Dec 2021
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HbA1c Variation Study
- ClinicalTrials.gov ID
- NCT05189938
- Acronym / sponsor ID
- ADC-US-RES-21212
- Conditions
- Diabetes Mellitus
- Keywords
- Professional FreeStyle Libre Flash Glucose Monitoring System, HBA1C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with type 1 or 2 diabetes.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBA1c data and glucose levelsAll 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. | Diagnostic test | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shridhara A Karinka, PhD study director
Abbott Diabetes Care
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Abbott Diabetes Care at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish a relationship between laboratory-derived HbA1c and average glucose levels (time frame: six (6) months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.