ext Generation Automated Insulin Delivery in Children and Adults with Type 1 Diabetes

Not Applicable

Not yet recruiting

• Conditions: Type 1 diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12624000907549
• Lead Sponsor: Health New Zealand - Southern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-25
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Male or female aged 2 years or older on day of consent.
2.Type 1 diabetes as per the American Diabetes Association Classification.
3.Duration of diabetes at least 12 months prior to Study Day 1 (or 6 months for those <7 years).
4.HbA1c of equal to or greater than 6.5% (48 mmol/mol) on day of consent.
5.Previous experience with 770G/780G systems for at least 3 months prior to study start.
6.Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 6 units/day.
7.Willing and able to adhere to the study protocol.
8.Adults aged 18 years or older with access to the internet and a computer system that meets requirements for uploading the study pump (willingness to attend clinic for upload is possible if no other option).
9.Children aged 2-17 years (inclusive) with at least one parent/legal guardian willing and able to upload system data as per preceding criterion, and proficient in basic diabetes management.

Exclusion Criteria

1.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.
2.Use of systemic glucocorticoids within 2 weeks prior to the Baseline visit.
3.Current use of Metformin, SGLT-2 or GLP-1 medications.
4.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.
5.Moderate to severe diabetic retinopathy.
6.If participant is of child-bearing potential, is pregnant or becomes pregnant while participating in the study. A positive urine pregnancy test at Screening is exclusionary.
7.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.
8.Planned travel either outside New Zealand, or in remote areas within New Zealand that would hinder study system data uploads.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycaemic control as measured by percentage of time in range 3.9 – 10mmol/L.[By way of CGM data analysis. At baseline, and at the 3, 6, and 9 weeks post-intervention commencement. ];Glycaemic control as measured by percentage of time below 3.9 mmol/L.[By way of CGM data analysis. At baseline, and at the 3, 6, and 9 weeks post-intervention commencement. ]