None listed
Conditions
Brief summary
This study will compare treatment satisfaction with Omnipod-DASH insulin pump with usual care with insulin pump therapy without sensor or multiple daily insulin injections in adults with Type 1 diabetes. We hypothesize that adults with Type 1 diabetes will report a more positive experience using Omnipod-DASH compared with their usual care.
Interventions
Arm 2: Omnipod-DASH insulin pump for 24 weeks
- Omnipod-DASH insulin pump is a minimally intrusive tubeless waterproof patch pump controlled from a handset (compared to current available insulin pumps in Australia, which involves an insulin infusion tubing connecting the pump to the insulin delivery cannula, making it conspicuous; and has to be disconnected during shower/swimming)
- participants will be educated on how to change the Omnipod-DASH insulin pump during the in-clinic visit where they
Arm 2: Omnipod-DASH insulin pump for 24 weeks - Omnipod-DASH insulin pump is a minimally intrusive tubeless waterproof patch pump controlled from a handset (compared to current available insulin pumps in Australia, which involves an insulin infusion tubing connecting the pump to the insulin delivery cannula, making it conspicuous; and has to be disconnected during shower/swimming) - participants will be educated on how to change the Omnipod-DASH insulin pump during the in-clinic visit where they are allocated to use the Omnipod-DASH insulin pump (start of intervention at Week 0 for Arm 2) - Omnipod-DASH insulin pump will need to be changed every 3 days - participants will be provided the Omnipod-DASH insulin pumps and its associated handset (which is used to control the Omnipod-DASH insulin pump via Bluetooth wireless technology) - education in the use of the pump and its associated handset will be delivered via face-to-face consultation by a nurse educator experienced in diabetes technology devices during the in-clinic visit where they are allocated to use the Omnipod-DASH insulin pump (start of intervention at Week 0 for Arm 2) for about an hour (depending on how much device training is required) - the education session will include programing basal rates and basal calculator settings; device changes; trouble shooting and uploading of pump data to the Diasend platform - all participants will be educated in the use of the KeyLead app, which is used to record some of the outcomes of interest during the course of the study after the start of the intervention at Week 0 - all participants will undergo education and confirmation of proficiency in carbohydrate counting with a dietician will occur prior to commencement of the intervention (Week -4 to -2). The dietician visits will usually occur twice and over an hour each (depending on how much prior experience participant has in this area) either by face-to-face or virtual consultations. - attendance to session visits will be monitored by attendance checklists; use of Omnipod-DASH insulin pump can be monitored by accessing the pump data from the Diasend platform (which will be uploaded during each review visit)
Sponsors
St Vincent's Hospital Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of type 1 diabetes (as defined by the American Diabetes Association) of at least six months duration managed with multiple daily injections (MDI) or insulin pump therapy (IPT) 2. Age 18-70 years old 3. Fluent in English (reading and writing) 4. Willing to perform at least four self-monitoring of blood glucose (SMBG) readings each day 5. Willing to learn how to carbohydrate count and to apply this knowledge 6. HbA1c <10.0% 7. Willing to use an Omnipod DASH insulin pump 8. Has a computer with internet access 9. Has access to a smart device with data plan.
Exclusion criteria
1. Using real time-CGM defined as use >25% of the time during the past 3 months (Abbott Libre allowed) 2. An episode of severe hypoglycaemia or DKA within the preceding three months 3. A physical or intellectual disability precluding the use of insulin pump therapy 4. Severe renal impairment (eGFR <15 ml per minute per 1.73m2) 5. Haemoglobinopathy or haemolytic anemia due to its interference with HbA1c assays 6. Major life-threatening illness impacting immediate life expectancy 7. Use of any non-insulin glucose-lowering agent within the past 3 months 8. Oral or injected corticosteroid use within the past 3 months 9. Pregnancy, or pregnancy planned within study period 10. Uncontrolled thyroid disease, celiac disease or hypertension 11. A requirement for more than 200 I.U. of insulin every two days.
Outcome results
None listed