Feasibility study for Development of an All-In-One Combined Insulin Cannula and Glucose Sensor as Part of a Automated Patch-Pump Insulin Delivery System in Adults with Type 1 Diabetes

Not Applicable

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

• Registration Number: ACTRN12621000912886
• Lead Sponsor: St Vincent's Hospital Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-14
• Study Completion: 2021-09-02
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Type 1 diabetes, of at least 6 months duration.
- Age 21-75 Years
- Insulin pump usage at the time of screening and for at least 3 months prior to screening.
- HbA1c between 5.8% and 9.0%
- Willingness and ability to follow all study procedures and to attend all clinic visits.
- Living with a person knowledgeable regarding the management of hypoglycaemia.
- No episodes of diabetic ketoacidosis and severe hypoglycaemia within the last 3 months

Exclusion Criteria

- Chronic kidney disease as defined by estimated-GFR < 45 ml/min
- Inability to read pump or CGM display due to reduced visual acuity
- Presence of unstable ischaemic heart disease or myocardial infarction within the last 3 months.
- Cognitive limitations precluding the participant’s ability to operate the insulin pump.
- Any major active medical condition which in the investigator’s opinion precludes involvement in the study. Known active infection such as HIV or hepatitis
- Schizophrenia or other untreated mental illness
- Chronic substance abuse
- Major surgical procedure within 30 days prior to screening
- Bleeding disorder, or treatment with anticoagulants
- Allergy to Lispro insulin
- Allergy to acrylate-based skin adhesives
- Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods.
- Diabetic ketoacidosis or major hypoglycemia within the last 6 months
- Insulin resistance as defined by insulin requirement of more than 200 units per day
- Use of glucose-lowering medications other than insulin
- Need for uninterrupted treatment with acetaminophen

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of time in target glucose range (TIR) 3.9-10 mmol/L measured by Dexcom G6 continuous glucose monitor[ For 6 hours post commencement of meal challenge ]