ANZCTR - Registration

Registration number

ACTRN12625000765426p

Ethics application status

Submitted, not yet approved

Date submitted

26/06/2025

Date registered

18/07/2025

Date last updated

18/07/2025

Date data sharing statement initially provided

18/07/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

OPAL study - User Experience with Tubeless Automated Insulin Delivery System (Omnipod 5)

Scientific title

Evaluating the User Experience with Omnipod 5: A Randomised Control Trial in Children and Young Adults with Type 1 Diabetes

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

OPAL

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Type 1 Diabetes

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention arm will receive an Omnipod 5 device for use during the 6-month study period. The Omnipod 5 consists of a pod unit with a reservoir of insulin inside, that has a cannula inserted subcutaneously in the user, and sits on top of the insertion site with an adhesive patch. An external controller device acts as the interface for manual bolus insulin infusion and for changing insulin delivery settings. The pump forms an Automated Insulin Delivery (AID) system by integrating with a Dexcom G6/G7 continuous glucose monitor (CGM), providing real-time changes to insulin delivery magnitude and frequency. The Omnipod 5 tubeless insulin pump is approved for use for people with Type 1 diabetes aged 2 and above in Australia through the Australian Therapeutic Goods Administration (ARTG ID 455009). The pump is accessible to families via private health insurance or self-funding, but will be provided to participants through the study. Participants will be asked to complete a series of questionnaires at baseline, mid-point (12 weeks) and end-of-study (24 weeks), assessing their experience with the Omnipod 5 insulin pump. Participants (and their families, if under the age of 18) receiving an Omnipod 5 will undergo training for insulin pump starts and the use of AID, to be conducted on site at Perth Children's Hospital Outpatient D research clinic by a diabetes educator within the study team. The diabetes educator will also review the participant's CGM data at each study visit to ensure the participant's safety and study compliance (i.e. CGM use greater than or equal to 70% of the time). At the end of the study period, participants may be approached to share their experiences through a semi-structured interview.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

The experiences of the intervention participants will be compared to those receiving 'usual care', who continue on their current insulin therapy (multiple daily injections (MDI) or tubed insulin pump). The control group will be asked to complete the same set of questionnaires as the intervention group. At the end of the 6-month study period, the control group will receive the opportunity to trial the Omnipod 5 (intervention device) for 3 months. The questionnaires will be readministered at the end of this additional and optional trial period.

Control group

Active

Outcomes

Primary outcome [1]

Difference in Diabetes Technology Questionnaire-current score

Timepoint [1]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this questionnaire 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [1]

Paediatric Quality of Life

Timepoint [1]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this questionnaire 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [2]

Problem Areas in Diabetes score

Timepoint [2]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this questionnaire 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [3]

User Experience score

Timepoint [3]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this questionnaire 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [4]

Time in Range (3.9-10.0 mmol/L)

Timepoint [4]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this measurement 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [5]

Quality of Life

Timepoint [5]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this questionnaire 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [6]

Fear of Hypoglycaemia aggregate score

Timepoint [6]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this questionnaire 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [7]

Time Above Range (greater than or equal to 10.0 mmol/L)

Timepoint [7]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this measurement 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [8]

Diabetes Technology Questionnaire-change score

Timepoint [8]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this questionnaire 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [9]

Glycaeted Haemoglobin (glucose outcome)

Timepoint [9]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this measurement 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [10]

Time Below Range (less than or equal to 3.9 mmol/L)

Timepoint [10]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this measurement 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [11]

Blood glucose monitoring frequency

Timepoint [11]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this measurement 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [12]

Proportion of individuals with a HbA1c below 7.0%

Timepoint [12]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this measurement 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [13]

Time Below Range (less than or equal to 3.0 mmol/L)

Timepoint [13]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this measurement 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [14]

Diabetes Medication Ratings

Timepoint [14]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this questionnaire 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [15]

System Useability score

Timepoint [15]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this questionnaire 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [16]

Basal/bolus ratio

Timepoint [16]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this measurement 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [17]

Economic Outcomes (Costs and Benefits) of Diabetes Therapies

Timepoint [17]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this measurement 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [18]

Experience of Omnipod 5 Users, exploring participants' perceptions of Omnipod 5 effectiveness and acceptability

Timepoint [18]

After the 24-week intervention period (Intervention arm only)

Secondary outcome [19]

Diabetic Ketoacidosis

Timepoint [19]

Continuous throughout study period

Secondary outcome [20]

Continuous Glucose Monitor (CGM) Use

Timepoint [20]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this measurement 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [21]

Time in Automated Insulin Delivery (AID) modes

Timepoint [21]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this measurement 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [22]

Time Above Range (greater than or equal to 13.9 mmol/L)

Timepoint [22]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this measurement 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [23]

Sleep Quality

Timepoint [23]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this questionnaire 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [24]

Insulin Pump and Continuous Glucose Monitoring (CGM) Alarm Frequency, assessed as a composite outcome

Timepoint [24]

Baseline, 12 weeks (midpoint of study) and 24 weeks (end of study). Control arm participants will repeat this measurement 3 months after the end of the study (36 weeks) if they take up the 3-month device trial at the end of the study.

Secondary outcome [25]

Severe Hypoglycaemia

Timepoint [25]

Continuous throughout study period

Secondary outcome [26]

Cost-effectiveness

Timepoint [26]

At the conclusion of the study.

Eligibility

Key inclusion criteria

• Child or young adult with Type 1 diabetes,
• Age 2-24 years,
• T1D duration of >1 year,
• On established insulin therapy: Multiple daily injections (MDI) or a tubed insulin pump for >3 months,
• Minimum daily insulin requirement of at least 5 units/day,
• 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, and
• Participant or guardian is able to operate the Omnipod 5.

Minimum age

2 Years

Maximum age

24 Years

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

• Prior use of a patch pump,
• Insulin requirement of >150 Units of insulin/day,
• Severe or unstable medical or psychological condition which, in the opinion of the treating physician and/or investigator, would compromise the ability to meet protocol requirements,
• A history of severe diabetic ketoacidosis or severe hypoglycaemia in the last 3 months,
• Poor visual acuity precluding the use of technology, or
• Pregnancy or planned pregnancy

Study design

Statistical methods / analysis

The primary outcome will be analysed using ANCOVA with the comparison of follow-up scores between group, adjusting for baseline scores. All other continuous outcomes will be analysed in similar manner. If required, data for some outcomes might be transformed, or rank sum test will be used instead. Differences between groups will be presented as mean/median difference with 95% confidence intervals. Binary outcomes will be compared using logistic regression. Exploratory subgroup analyses will be performed according to mode of insulin delivery and age. Missing data will be replaced under a “missing at random” assumption and will be multiply imputed using a multivariate normal regression imputation method, with imputations performed separately for each treatment arm. Sensitivity analyses of the primary outcome will include changing the missing data replacement assumption to “missing completely at random” and to “missing not at random” as well as to the per-protocol population.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

31/08/2025

Actual

Date of last participant enrolment

Anticipated

31/08/2027

Actual

Date of last data collection

Anticipated

29/03/2028

Actual

Sample size

Target

74

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

WA,VIC

Recruitment hospital [1]

Perth Children's Hospital - Nedlands

Recruitment hospital [2]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment postcode(s) [1]

6009 - Nedlands

Recruitment postcode(s) [2]

3065 - Fitzroy

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Insulet Australia Pty Ltd.

Country [1]

Australia

Primary sponsor type

Government body

Name

Child and Adolescent Health Service (CAHS)

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Child and Adolescent Health Service Human Research Ethics Committee

Ethics committee address [1]

https://cahs.health.wa.gov.au/Research/For-researchers/Ethics-and-governance-approval

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/06/2025

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

This research study is to compare the user experience with Omnipod 5 and ‘usual care’ in people living with type 1 diabetes. This study will be unique in that it will assess the user experience with automated insulin delivery (AID) enabled pod therapy across the lifespan of those with T1D from young children, through adolescence to adulthood and older adulthood, using closely aligned methodology. We hypothesise that Omnipod 5 use will be associated with a positive user experience and improved quality of life and other psychosocial measures compared to ‘usual care’ with multiple daily injections and tubed insulin pumps.

Trial website

Public notes

Contacts

Principal investigator

Name

Dr Mary Abraham

Address

15 Hospital Ave, Perth Children's Hospital, Nedlands, WA, 6009

Country

Australia

Phone

+61 8 6456 5027

Email

[email protected]

Contact person for public queries

Name

Mary Abraham

Address

15 Hospital Ave, Perth Children's Hospital, Nedlands, WA, 6009

Country

Australia

Phone

+61 8 6456 5027

Email

[email protected]

Contact person for scientific queries

Name

Mary Abraham

Address

15 Hospital Ave, Perth Children's Hospital, Nedlands, WA, 6009

Country

Australia

Phone

+61 8 6456 5027

Email

[email protected]

Trial Review

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Documents added automatically