Automated insulin delivery to optimise current care for Maori and Pacific peoples living with type 1 diabetes

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

1.Adults of Maori or Pacific ethnicity, any gender, aged 16 – 65 years inclusive on day of consent.
2.Type I diabetes as per the American Diabetes Association Classification, diagnosed at least 1 year prior to Study Day 1.
3.Current HbA1c level of greater than or equal to 8.0% (64 mmol/mol).
4.Minimum daily insulin requirement (total daily dose [TDD]) of greater than or equal to 8 units.
5.Willing and able to adhere to the study protocol.
6.Access to the internet and a computer system that meets requirements for uploading the study pump.

Exclusion Criteria

1.Previous use of automated insulin delivery technology prior to baseline visit.
2.Previous significant adverse event at investigator discretion that precludes the participant safely using advanced diabetes technology/sensors e.g., unable to wear glucose sensors due to prior cutaneous adverse events.
3.Use of systemic glucocorticoids within 2 weeks prior to the Baseline visit.
4.Current use of Metformin, SGLT-2 or GLP-1 medications.
5.History or current evidence of severe psychiatric disorder, uncontrolled seizure disorder, renal impairment or cardiovascular disease (including uncontrolled hypertension), or severe visual impairment that in the opinion of the Investigator would limit study involvement or be a safety issue.
6.Known moderate to severe diabetic retinopathy.
7.If participant is of child-bearing potential, is pregnant or plans to become pregnant while participating in the study. A positive urine pregnancy test at Screening is exclusionary.
8.Any clinically significant pre-existing medical 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycaemic control as measured by glycated hemoglobin (HbA1C) from blood samples.[Measured via point-of-care analyzer or diagnostics laboratory whole blood analysis. At baseline, and at 3 (primary endpoint), 6, 9, and 12 months postintervention phase commencement.]

Secondary Outcome Measures