Status:
UNKNOWN
Assessment of Two Insulin Pump Insulin Delivery Systems in Type 1 Diabetes.
Lead Sponsor:
Christchurch Clinical Studies Trust Ltd
Collaborating Sponsors:
Medtronic
Conditions:
Type1diabetes
Eligibility:
All Genders
7-80 years
Phase:
NA
Brief Summary
This is a study of the Minimed 670G 4.0 insulin pump, assessing the efficacy of the Advanced Hybrid Closed Loop (AHCL) algorithm in controlling blood glucose levels in Type 1 Diabetes.
Detailed Description
Insulin delivery systems are an increasingly popular treatment option for Type I Diabetes (T1D). Delivery systems consist of an insulin pump, a glucose sensor with a transmitter attached, and a maths ...
Eligibility Criteria
Inclusion
- Male or female aged 7 - 80 years inclusive.
- Type I diabetes as per the American Diabetes Association Classification, diagnosed at least 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 8 units.
- Willing and able to adhere to the study protocol.
- Access to the internet and a computer system that meets requirements for uploading the study pump.
Exclusion
- Mean HbA1c more than 10.0% (86 mmol/mol) within 6 months prior to Study Day 1 (minimum of one test).
- Use of a medication indicative of diabetes complications (ACE inhibitors and statins are 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 or cardiovascular disease (including uncontrolled hypertension), in the opinion of the Investigator.
- 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. A positive 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 that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
Key Trial Info
Start Date :
May 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 11 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04073576
Start Date
May 20 2019
End Date
October 11 2019
Last Update
August 29 2019
Active Locations (1)
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1
Christchurch Clinical Studies Trust
Christchurch, Canterbury, New Zealand, 8011