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Trial registered on ANZCTR
Registration number
ACTRN12625000717459p
Ethics application status
Submitted, not yet approved
Date submitted
11/06/2025
Date registered
7/07/2025
Date last updated
7/07/2025
Date data sharing statement initially provided
7/07/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Evaluating the User Experience with Omnipod 5: A whole lifespan trial.
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Scientific title
Evaluating the User Experience with Omnipod 5: A whole lifespan trial in People with Type 1 Diabetes (Adult [>24Y Age] Cohort Only)
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Secondary ID [1]
314623
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes
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Condition category
Condition code
Metabolic and Endocrine
334095
334095
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
331247
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Treatment: Devices
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Comparator / control treatment
People living with Type 1 Diabetes receiving standard care which is their current insulin therapy including multiple daily injections or insulin pump therapy.
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Control group
Active
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Outcomes
Primary outcome [1]
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Difference in Diabetes Technology Questionnaire (Current) score
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Assessment method [1]
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Diabetes Technology Questionnaire (Current) score
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Timepoint [1]
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- Week 0: Baseline, primary time point when intervention commenced. - Week 12 from primary time point. - Week 24 from primary time point.
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Secondary outcome [1]
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Health Related Quality of Life
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Assessment method [1]
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Assessed using the EuroQol Five Dimensions Health-Related Quality of Life Questionnaire. • International Physical Activity Questionnaire
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Timepoint [1]
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- Week 0 (baseline) - Week 12 post intervention commencement - Week 24 post intervention commencement - Week 36 post intervention commencement (optional extension phase)
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Secondary outcome [2]
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Sleep Quality
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Assessment method [2]
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Assessed with the Pittsburgh Sleep Quality Index
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Timepoint [2]
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- Week 0 (baseline) - Week 12 post intervention commencement - Week 24 post intervention commencement - Week 36 post intervention commencement (optional extension phase)
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Secondary outcome [3]
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Measure of satisfaction with diabetes technological tools
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Assessment method [3]
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Diabetes Technology Questionnaire-change
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Timepoint [3]
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- Week 0 (baseline) - Week 12 post intervention commencement - Week 24 post intervention commencement - Week 36 post intervention commencement (optional extension phase)
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Secondary outcome [4]
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Treatment experience of diabetes system used.
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Assessment method [4]
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Measured by Diabetes Medication System Rating Questionnaire
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Timepoint [4]
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- Week 0 (baseline) - Week 12 post intervention commencement - Week 24 post intervention commencement - Week 36 post intervention commencement (optional extension phase)
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Secondary outcome [5]
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Fear of hypoglycaemia
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Assessment method [5]
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Assessed by hypoglycaemia fear survey
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Timepoint [5]
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- Week 0 (baseline) - Week 12 post intervention commencement - Week 24 post intervention commencement - Week 36 post intervention commencement (optional extension phase)
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Secondary outcome [6]
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Diabetes Distress
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Assessment method [6]
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Assessed by Problem Areas in Diabetes scale
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Timepoint [6]
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- Week 0 (baseline) - Week 12 post intervention commencement - Week 24 post intervention commencement - Week 36 post intervention commencement (optional extension phase)
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Secondary outcome [7]
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System Usability of diabetes device.
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Assessment method [7]
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Assessed by System Useability Scale
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Timepoint [7]
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- Week 0 (baseline) - Week 12 post intervention commencement - Week 24 post intervention commencement - Week 36 post intervention commencement (optional extension phase)
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Secondary outcome [8]
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User Experience of interactive products
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Assessment method [8]
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Assessed by User Experience Questionnaire
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Timepoint [8]
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- Week 0 (baseline) - Week 12 post intervention commencement - Week 24 post intervention commencement - Week 36 post intervention commencement (optional extension phase)
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Secondary outcome [9]
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Physical activity levels in adults
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Assessment method [9]
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International Physical Activity Questionnaire
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Timepoint [9]
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- Week 0 (baseline) - Week 12 post intervention commencement - Week 24 post intervention commencement - Week 36 post intervention commencement (optional extension phase)
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Secondary outcome [10]
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Glycated haemoglobin (HbA1c)
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Assessment method [10]
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Will be assessed with a blood test of HbA1c and proportion of individuals with an HbA1c below 7% (53 mmol/mol)
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Timepoint [10]
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- Week -2 (Screening visit) - Week 12 post intervention commencement - Week 24 post intervention commencement
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Secondary outcome [11]
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Continuous Glucose Monitoring (CGM) time glucose levels are spent in very high, high, in range, low and very low.
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Assessment method [11]
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Will be assessed from data uploads of participants' CGM devices for metrics including very high, high, in range, low and very low.
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Timepoint [11]
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- Week 0 (baseline) - Week 12 post intervention commencement - Week 24 post intervention commencement
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Secondary outcome [12]
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Percentage (%) of time CGM used
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Assessment method [12]
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Will be assessed from data uploads of participants' CGM devices for % time CGM used.
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Timepoint [12]
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- Week 0 (baseline) - Week 1 post intervention commencement - Week 2 post intervention commencement - Week 3 post intervention commencement - Week 4 post intervention commencement - Week 8 post intervention commencement - Week 12 post intervention commencement - Week 24 post intervention commencement
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Secondary outcome [13]
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Percentage (%) of time in Automated Insulin Delivery (AID) system.
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Assessment method [13]
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Will be assessed from data uploads of participants' CGM devices for % time in AID system.
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Timepoint [13]
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- Week 0 (baseline) - Week 1 post intervention commencement - Week 2 post intervention commencement - Week 3 post intervention commencement - Week 4 post intervention commencement - Week 8 post intervention commencement - Week 12 post intervention commencement - Week 24 post intervention commencement
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Secondary outcome [14]
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Number of alarms (n)
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Assessment method [14]
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Will be assessed from data uploads of participants' CGM devices for (n) alarms.
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Timepoint [14]
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- Week 0 (baseline) - Week 1 post intervention commencement - Week 2 post intervention commencement - Week 3 post intervention commencement - Week 4 post intervention commencement - Week 8 post intervention commencement - Week 12 post intervention commencement - Week 24 post intervention commencement
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Secondary outcome [15]
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Percentage (%) of insulin delivered by user-initiated bolus
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Assessment method [15]
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Will be assessed from data uploads of participants' CGM devices for % of user-initiated boluses.
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Timepoint [15]
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- Week 0 (baseline) - Week 1 post intervention commencement - Week 2 post intervention commencement - Week 3 post intervention commencement - Week 4 post intervention commencement - Week 8 post intervention commencement - Week 12 post intervention commencement - Week 24 post intervention commencement
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Secondary outcome [16]
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Number of fingerstick glucose readings.
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Assessment method [16]
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Will be assessed by asking participants the number of times of times per day on average that they perform fingerstick glucose readings.
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Timepoint [16]
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- Week 0 (baseline) - Week 1 post intervention commencement - Week 2 post intervention commencement - Week 3 post intervention commencement - Week 4 post intervention commencement - Week 8 post intervention commencement - Week 12 post intervention commencement - Week 24 post intervention commencement
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Secondary outcome [17]
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User perceptions of Omnipod 5 effectiveness and acceptability.
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Assessment method [17]
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Semi-structured Interviews
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Timepoint [17]
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- Week 24 post intervention commencement (end of study visit)
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Eligibility
Key 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.
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Minimum age
24
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will occur through central randomisation by computer.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2025
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Actual
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Date of last participant enrolment
Anticipated
1/01/2027
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Actual
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Date of last data collection
Anticipated
1/07/2027
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Actual
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Sample size
Target
74
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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St Vincent's Hospital
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Address [1]
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Country [1]
319185
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Australia
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Primary sponsor type
Hospital
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Name
St Vincent's Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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Insulet
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Address [1]
321663
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Country [1]
321663
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United States of America
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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St Vincent's Hospital Melbourne Human Research Ethics Committee
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Ethics committee address [1]
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https://svhm.org.au/home/research/researchers/human-research-ethics-committee
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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19/05/2025
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Approval date [1]
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Ethics approval number [1]
317767
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof David O'Neal
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Address
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Level 4, Building D, D41, Daly Wing North, St Vincent's Hospital 35 Victoria Parade, Fitzroy, Vic 3065
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Country
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Australia
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Phone
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+61425731665
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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David O'Neal
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Address
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Level 4, Building D, D41, Daly Wing North, St Vincent's Hospital 35 Victoria Parade, Fitzroy, Vic 3065
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Country
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Australia
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Phone
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+61425731665
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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David O'Neal
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Address
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Level 4, Building D, D41, Daly Wing North, St Vincent's Hospital 35 Victoria Parade, Fitzroy, Vic 3065
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Country
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Australia
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Phone
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+61425731665
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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