None listed
Conditions
Brief summary
Omnipod 5 is a wearable insulin pump that doesn't use any tubes and can automatically adjust insulin based on blood sugar levels, which it gets from a continuous glucose monitor (CGM). Because it is tubeless and can manage insulin on its own, it might be more comfortable and easier to use than current treatments for type 1 diabetes like multiple daily injections or traditional insulin pumps with tubes. Previous research studies looking at insulin pump systems have been primarily on glucose control. The purpose of this study is to gain insight into the experience of people with T1D using the Omnipod 5 compared to their usual treatment (either injections and CGM or a tubed pump and CGM), and impact on their quality of life (QoL). It is increasingly recognised that diabetes management extends beyond glucose control alone and an individual's wellbeing and quality of life are critical considerations in diabetes management. The aim of this study is to assess whether people using the Omnipod 5 report a better overall experience and improved QoL compared to those receiving their usual treatment. We will recruit 74 adults with T1D and randomly assign them into 2 groups; Group 1 participants will use Omnipod 5 or Group 2 where participants will continue using their current T1D care plan for a total of 6 months. Participants will be assessed for sleep quality, physical activity periods, quality of life, and clinical outcomes. We hypothesise that the Omnipod 5 will be associated with improved quality of life and management of T1D on a daily basis.
Interventions
Omnipod 5 is a current generation Automated Insulin Delivery (AID) enabled tubeless insulin pump.
The aim is to conduct a randomised controlled study comparing the user experience with Omnipod 5 and ‘usual care’ in people living with Type 1 Diabetes (T1D).
Seventy-four adults with a diagnosis of type 1 diabetes managed with MDI or Insulin Pump Therapy (IPT) will be recruited from five tertiary hospitals in Victoria and South Australia for a total duration of 26 weeks.
The study has the followin
Omnipod 5 is a current generation Automated Insulin Delivery (AID) enabled tubeless insulin pump. The aim is to conduct a randomised controlled study comparing the user experience with Omnipod 5 and ‘usual care’ in people living with Type 1 Diabetes (T1D). Seventy-four adults with a diagnosis of type 1 diabetes managed with MDI or Insulin Pump Therapy (IPT) will be recruited from five tertiary hospitals in Victoria and South Australia for a total duration of 26 weeks. The study has the following phases: 1. Screening Period: the study doctor will explain to the participant what the study involves and the participant will have time to read the Participant. Information Sheet and Consent Form and ask any questions. If they agree to participate in the study they will undergo medical history, physical examination and investigational tests. 2. Run-in period (14 days): participants will be provided with a wrist-worn actigraphy device to wear for the 14 days and complete daily sleep and physical activity diaries for the 14 days. 3. Treatment period (24 weeks): all participants will be randomly allocated to 24 weeks of either continuing their usual care (MDI or IPT, with general diabetes education) or commencing on the Omnipod 5 insulin pump (with relevant education provided in person by the study doctor and nurse who have training in Omnipod 5). The education will be provided immediately after random allocation for 30 minutes. This review will be in person in the clinical trials centre but future reviews may be over the phone or in person. During the treatment period advice and supervision for the management of T1D will be provided whether the participant is in the usual care or Omnipod 5 group. For the Omnipod 5 group a supervised in person pod change will occur 3 days after randomisation. For both groups all participants will have remote phone calls during weeks 1, 2, 3, 4, 8 for safety monitoring and review of device data which participants will be required to upload. Participants will also have in person clinical monitoring visits in the clinical trials centre in week 10, 12, 22, and 24 which will include device data review and administration of questionnaires. 4. Optional Extension period (12 weeks): participants allocated to usual care will have the option of a 3 month extension where they will be able to trial Omnipod 5 and questionnaires will be completed at the conclusion of this. These questionnaires will be included in the data analysis.
Sponsors
St Vincent's Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
24 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
• Aged between 24 and 85 years of age inclusive (at least 25% >65Y to 85Y) • Diagnosed with T1D for at least 1 year • HbA1c 3 months • Proficient in carbohydrate counting • Have CGM sensor experience and willing to use CGM for the duration of the study • Willing and able to adhere to the requirements of the protocol • Participant or guardian is able to operate the Omnipod 5.
Exclusion criteria
• Pregnancy or planned pregnancy • eGFR <40ml/min/1.73m2\ • Prior use of a patch pump • More than 150 Units of insulin/day • A history of diabetic ketoacidosis in the last 3 months • Diabetic gastroparesis • Tape allergy • Unable to exercise • Rrecreational substance abuse • Major medical or psychiatric illness
Outcome results
None listed