Status:
COMPLETED
HbA1c Variation Study
Lead Sponsor:
Abbott Diabetes Care
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
4+ years
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. U...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT05189938
Start Date
December 20 2021
End Date
December 30 2023
Last Update
May 25 2025
Active Locations (22)
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1
Excellence Research and Medical
Miami Gardens, Florida, United States, 33169
2
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States, 83404
3
Billings Clinic
Billings, Montana, United States, 59101
4
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, United States, 87109