Insulin Pump therapy for Reducing Diabetic complications (InsPyReD) study

Phase 2

Withdrawn

• Conditions: Diabetes; Type 1 diabetes; Diabetic Neuropathy; Neurological - Neurodegenerative diseases; Metabolic and Endocrine - Diabetes; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12617000124336
• Lead Sponsor: niversity of New South Wales Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-24
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

History of type 1 diabetes, currently on multiple daily insulin injections but deemed suitable for continuous subcutaneous insulin infusions (CSII/Pump therapy) by treating endocrinologist. 18-45 years of age.

Exclusion Criteria

a. Previous insulin pump therapy
b. Severe neuropathy, leading to difficulty with performing neurophysiological assessments.
c. Administration of another investigational drug within 30 days prior to randomisation.
d. Significant neurological or psychiatric disorders.
e. History of other conditions aside from type 1 diabetes that cause neuropathy (e.g end stage kidney disease).
f. Known pregnancy.
g. Known medical history causing reduced corneal sensation and neurotrophic keratitis (e.g. viral infections, chemical burns, corneal surgery, excessive use of topical anaesthetic, history of fifth nerve palsy and multiple sclerosis).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Corneal confocal microscopy will be used to determine the level of nerve damage in the eye. Nerve fiber density, length and tortuosity will be assessed.[6, 12, 18 AND 24 MONTHS ON INTERVENTION OR STANDARD CARE]