Comparison of Treatment Satisfaction between the Omnipod Insulin Pump and Usual Care in Adults with Type 1 Diabetes in Australia
- Conditions
- Type 1 diabetesMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12621001195842
- Lead Sponsor
- St Vincent's Hospital Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 65
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method