None listed
Conditions
Brief summary
This study aims to determine whether insulin pump therapy can prevent nerve injury in patients with type 1 diabetes Who is it for? You can join this study if you have type 1 diabetes, aged 18-45 years and have not received insulin pump therapy before Trial details In this study, participants are randomly (by chance) divided into two groups. One group will receive an insulin pump free of charge for a period of 2 years. The other group will receive standard insulin injection therapy. Participants will undergo non-invasive nerve and eye tests to determine their suitability for the trial and when enrolled, will undergo these follow-up assessments at 6, 12, 18 and 24 months, coinciding with their usual endocrinology appointments. Both groups will receive continuous glucose monitoring at the beginning and end of the trial to determine the effect of glucose variability on nerve function. Participants will also undergo assessments of their quality of life specific to any nerve damage they may have.
Interventions
Eligible participants will be randomised to either control (standard multiple daily insulin injections) or the intervention group (insulin pump therapy) for a period of 2 years.
The intervention, insulin pump therapy (using model MMT-754 Medtronic MiniMed Paradigm Veo), will be administered at the Diabetes Centre at the Prince of Wales Hospital via standard clinical procedures; this typically involves intensive consultation with an Endocrinologist (Director of the Diabetes Centre and CIC, Dr A
Eligible participants will be randomised to either control (standard multiple daily insulin injections) or the intervention group (insulin pump therapy) for a period of 2 years. The intervention, insulin pump therapy (using model MMT-754 Medtronic MiniMed Paradigm Veo), will be administered at the Diabetes Centre at the Prince of Wales Hospital via standard clinical procedures; this typically involves intensive consultation with an Endocrinologist (Director of the Diabetes Centre and CIC, Dr Ann Poynten) and a nurse educator on pump use, in addition to multiple appointments to ensure pumps are calibrated appropriately to achieve glucose control whilst minimising risk of hypoglycaemic events. These appointments last about 1 hr and typically occur once a week for the first 2-3 weeks after pump initiation. Once pumps are calibrated appropriately, standard endocrinology follow-up appointments will occur for approximately 30 minutes at 6, 12, 18 and 24 months. At these time points, outcome measures for the trial will also be obtained and take approximately 1 hr. Documentation provided: Participants will also be educated on the use of the pump in face to face appointments and provided with information and documentation specific to the model of the pump being implemented (provided as part of the standard commercial pump package). Participants will also be provided with contact details of the trial co-ordinator (Dr Natalie Kwai) and in the case of an emergency related to their diabetes, CIC Poynten's on-call contact details.
Sponsors
University of New South Wales Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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).
Outcome results
None listed