Investigating the efficacy and safety of a prototype ultra-low-cost insulin pump (ULCIP)

Not Applicable

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

• Registration Number: ACTRN12623001288617
• Lead Sponsor: niversity of Canterbury

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-11
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Type 1 diabetes as classified by the American Diabetes Association
2. Aged 18 years or older
3. Currently using insulin pump therapy for management of diabetes
4. Currently receiving basal insulin at a rate compatible with the investigational ultra-low-cost insulin pump
5. HbA1c < 97 mmol/mol (11.0%), based on the mean of all HbA1c results within the 6 months prior to the screening visit, or HbA1c at screening if no results are available
within the prior 6 months.
6. Willing and able to adhere to the study protocol

Exclusion Criteria

1. A positive pregnancy test at screening is exclusionary
2. If female, is currently breastfeeding
3. Severe hypoglycaemia or diabetic ketoacidosis in the 6 months prior to study commencement.
4. Allergic or intolerant to Humalog® and NovoRapid® insulin
5. Alcohol or drug dependence (as reported by participants)
6. Any comorbid medical or psychological factors that would, on assessment by the investigators, make the person unsuitable for the study
7. A lack of English literacy that would, on assessment by the investigators, make the person unsuitable for the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified