Phase
Condition
Diabetes And Hypertension
Diabetes Prevention
Diabetes Mellitus, Type 1
Treatment
N/AClinical Study ID
Ages 7-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female aged 7 - 80 years inclusive.
Type I diabetes as per the American Diabetes Association Classification, diagnosed atleast 1 year prior to Study Day 1.
On insulin pump therapy for at least 6 months prior to study Day 1.
Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8units.
Willing and able to adhere to the study protocol.
Access to the internet and a computer system that meets requirements for uploading thestudy pump.
Exclusion
Exclusion Criteria:
Mean HbA1c more than 10.0% (86 mmol/mol) within 6 months prior to Study Day 1 (minimumof one test).
Use of a medication indicative of diabetes complications (ACE inhibitors and statinsare permitted).
Use of systemic glucocorticoids within 2 weeks prior to the Baseline visit.
Current use of SGLT-2 or GLP-1 medications.
History or current evidence of significant seizure disorder, renal impairment orcardiovascular disease (including uncontrolled hypertension), in the opinion of theInvestigator.
History of severe visual impairment, in the opinion of the Investigator.
If female, is pregnant or plans to become pregnant while participating in the study. Apositive urine pregnancy test at Screening is exclusionary.
Any clinically significant concomitant disease or condition that could interfere with,or for which the treatment of might interfere with, the conduct of the study, or thatwould, in the opinion of the investigator, pose an unacceptable risk to the subject inthis study.
Study Design
Study Description
Connect with a study center
Christchurch Clinical Studies Trust
Christchurch, Canterbury 8011
New ZealandActive - Recruiting
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