HbA1c Variation Study

Sponsor
Abbott Diabetes Care (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05189938
Collaborator
(none)
600
11
11.4
54.5
4.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: HBA1c data and glucose levels

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

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
HbA1c Variation Study
Actual Study Start Date :
Dec 20, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Establish a relationship between laboratory-derived HbA1c and average glucose levels [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
  1. Subject is currently undergoing dialysis or planning to receive dialysis during the course of the study

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

  3. 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.

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

  5. 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).

  6. 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.

  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 the Investigator.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Billings Clinic Billings Montana United States 59101
2 Eastside Research Associates Redmond Washington United States 98052
3 Royal Derby Hospital Derby United Kingdom DE22 3NE
4 Edinburgh Royal Infirmary Edinburgh United Kingdom EH1 3EG
5 Hull Royal Infirmary Hull United Kingdom HU3 2JZ
6 St James University Hospital Leeds United Kingdom LS9 7TF
7 Leicester General Hospital Leicester United Kingdom LE1 5WW
8 Manchester Royal Infirmary Manchester United Kingdom M13 9WL
9 Royal Berkshire Hospital Reading United Kingdom RG1 5AN
10 Northern General Hospital Sheffield United Kingdom S10 2SB
11 The Royal London Hospital Whitechapel United Kingdom E1 1FR

Sponsors and Collaborators

  • Abbott Diabetes Care

Investigators

  • Study Director: Shridhara A Karinka, PhD, Abbott Diabetes Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Diabetes Care
ClinicalTrials.gov Identifier:
NCT05189938
Other Study ID Numbers:
  • ADC-US-RES-21212
First Posted:
Jan 13, 2022
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Abbott Diabetes Care

Study Results

No Results Posted as of Aug 25, 2022