Phase
Condition
Diabetes Prevention
Diabetes And Hypertension
Treatment
HBA1c data and glucose levels
Clinical Study ID
Ages > 4 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 instructionsprovided to him/her by the study site and perform all study tasks as specified bythe protocol.
Subject must be available to participate in all study visits.
Subject must be willing and able to provide written signed and dated informedconsent.
Subjects age 4 - 17: Parent or guardian must be willing and able to provide writtensigned and dated informed consent.
Subjects age 11 - 17 Subject must be willing and able to provide written signed anddated informed assent.
Exclusion
Exclusion Criteria:
Subject is currently undergoing dialysis or planning to receive dialysis during thecourse of the study
History of blood transfusion in the last 3 months or planned blood transfusionduring the course of the study.
Subject is currently planning to undergo a major medical intervention expected tosignificantly alter red cell life span, i.e. chemotherapy, major surgery requiringblood transfusions, etc.
Subject has known allergy to medical grade adhesive or isopropyl alcohol used todisinfect skin.
Subjects age 18 and older: Subject is known to be pregnant, attempting to conceiveor 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 knownto be pregnant at the time of study enrollment or is planning to become pregnantduring the study (applicable to female subjects only).
Subject has extensive skin changes/diseases at the proposed application sites thatcould interfere with device placement or the accuracy of interstitial glucosemeasurements. Such conditions include, but are not limited to extensive psoriasis,recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitisherpetiformis, 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 theInvestigator.
Study Design
Study Description
Connect with a study center
University Hospital Birmingham
Birmingham, B9 5PU
United KingdomSite Not Available
Bradford Royal Infirmary
Bradford, BD9 6RJ
United KingdomSite Not Available
Royal Derby Hospital
Derby, DE22 3NE
United KingdomSite Not Available
Edinburgh Royal Infirmary
Edinburgh, EH1 3EG
United KingdomSite Not Available
Northwick Park Hospital
Harrow, HA1 3UJ
United KingdomSite Not Available
Hull Royal Infirmary
Hull, HU3 2JZ
United KingdomSite Not Available
St James University Hospital
Leeds, LS9 7TF
United KingdomSite Not Available
Leicester General Hospital
Leicester, LE1 5WW
United KingdomSite Not Available
Manchester Royal Infirmary
Manchester, M13 9WL
United KingdomSite Not Available
Nottingham Children's Hospital & Queen's Medical Centre
Nottingham, NG7 2UH
United KingdomSite Not Available
Royal Berkshire Hospital
Reading, RG1 5AN
United KingdomSite Not Available
Northern General Hospital
Sheffield, S10 2SB
United KingdomSite Not Available
Ealing Hospital
Southall, UB1 3HW
United KingdomSite Not Available
The Royal London Hospital
Whitechapel, E1 1FR
United KingdomSite Not Available
Excellence Research and Medical
Miami Gardens, Florida 33169
United StatesSite Not Available
Rocky Mountain Clinical Research
Idaho Falls, Idaho 83404
United StatesSite Not Available
Billings Clinic
Billings, Montana 59101
United StatesSite Not Available
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico 87109
United StatesSite Not Available
Anmed Health Internal Medicine Associates
Anderson, South Carolina 29621
United StatesSite Not Available
Prime Revival Research Institute
Flower Mound, Texas 75028
United StatesSite Not Available
Eastside Research Associates
Redmond, Washington 98052
United StatesSite Not Available
Rainier Clinical Research Center
Renton, Washington 98057
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.