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Trial registered on ANZCTR


Registration number
ACTRN12621001195842
Ethics application status
Approved
Date submitted
6/07/2021
Date registered
8/09/2021
Date last updated
8/09/2021
Date data sharing statement initially provided
8/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of Treatment Satisfaction between the Omnipod Insulin Pump and Usual Care in Adults with Type 1 Diabetes in Australia
Scientific title
A Pilot Study Comparing Treatment Satisfaction with the Omnipod Insulin Pump Compared with Usual Care in Adults with Type 1 Diabetes Living in Australia
Secondary ID [1] 304553 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 322431 0
Condition category
Condition code
Metabolic and Endocrine 320083 320083 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 320904 0
Treatment: Devices
Comparator / control treatment
Arm 1: Participants' usual diabetes management (either multiple daily insulin injections or insulin pump therapy) for 12 weeks, followed by 12-weeks of using Omnipod-DASH insulin pump (total duration of 24 weeks)
- participants will receive education on how to change the Omnipod-DASH insulin pump and in the use of the pump and its associated handset 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 (12-weeks from start of intervention at Week 12) 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
- 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)
- 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.
- 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
Control group
Active

Outcomes
Primary outcome [1] 327961 0
Treatment satisfaction measured by the difference in the Diabetes Technology Questionnaire (DTS) score
Timepoint [1] 327961 0
Baseline (Week -4), Week 12 and Week 24 post intervention commencement
Secondary outcome [1] 397100 0
Psychological outcome measured by the Problem Areas in Diabetes (PAID) questionnaire
Timepoint [1] 397100 0
Baseline (Week -4), Week 12 and Week 24 post intervention commencement
Secondary outcome [2] 397101 0
Psychological outcome measured by the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [2] 397101 0
Baseline (Week -4), Week 12 and Week 24 post intervention commencement
Secondary outcome [3] 397102 0
Psychological outcome measured by Hypoglycaemia Fear Survey (HFS-11)
Timepoint [3] 397102 0
Baseline (Week -4), Week 12 and Week 24 post intervention commencement
Secondary outcome [4] 397103 0
Psychological outcome measured by the INsulin Delivery System Rating Questionnaire (IDSRQ)
Timepoint [4] 397103 0
Baseline (Week -4), Week 12 and Week 24 post intervention commencement
Secondary outcome [5] 397105 0
Effectiveness, efficiency and user satisfaction with Omnipod-DASH insulin pump measured via User Experience Questionnaire (UEQ)
Timepoint [5] 397105 0
Baseline (Week -4), Week 12 and Week 24 post intervention commencement
Secondary outcome [6] 397106 0
Effectiveness, efficiency and user satisfaction with Omnipod-DASH insulin pump measured via System Usability Scale (SUS)
Timepoint [6] 397106 0
Baseline (Week -4), Week 12 and Week 24 post intervention commencement
Secondary outcome [7] 397107 0
Duration of education based on documentation of start and end times of education sessions
Timepoint [7] 397107 0
During the dietician visits 4 weeks before the intervention (Week -4 to -2), and the start of intervention (Week 0)
For Arm 1, this will also occur 12-weeks post intervention (Week 12)
Secondary outcome [8] 397108 0
Time to change pods recorded via KeyLead App
Timepoint [8] 397108 0
Continuously throughout study duration
Secondary outcome [9] 397109 0
Time to change insulin pump sets recorded via KeyLead App
Timepoint [9] 397109 0
Continuously throughout study duration
Secondary outcome [10] 397112 0
Acceptability of Omnipod-DASH insulin pump device assessed via an open-ended one-on-one interview
- for approximately 30minutes
- audio recorded and transcribed for later thematic analysis
Timepoint [10] 397112 0
Week 12 and Week 24 post-intervention commencement
Secondary outcome [11] 397114 0
HbA1c via blood test
Timepoint [11] 397114 0
Baseline (Week -4), Week 12 and Week 24 post-intervention commencement
Secondary outcome [12] 397115 0
Percentage of time in range (3.9-10 mmol/L) measured by continuous glucose monitor (CGM)
Timepoint [12] 397115 0
2 weeks before study commencement (Week -2 to 0), Week 10 to 12 and Week 22 to 24 post-intervention commencement
Secondary outcome [13] 397116 0
Number of symptomatic hypoglycaemic events defined as an event with typical symptoms of hypoglycaemia accompanied by measured plasma glucose concentration of 3.9 mmol/L or less, recorded by KeyLead App
Timepoint [13] 397116 0
Continuously throughout study duration
Secondary outcome [14] 397117 0
Healthcare professional perception as assessed via an open-ended 30-minute interview
- involving 1 medical and 1 nursing healthcare professional involved in the study
- audio recorded and transcribed for later thematic analysis
Timepoint [14] 397117 0
Week 24 post intervention commencement
Secondary outcome [15] 397118 0
Number of line occlusions as recorded by KeyLead App
Timepoint [15] 397118 0
Continuously throughout study duration
Secondary outcome [16] 397119 0
Number of calls to helplines as recorded by KeyLead App
Timepoint [16] 397119 0
Continuously throughout study duration
Secondary outcome [17] 397120 0
Number of skin reactions as recorded by KeyLead App
Timepoint [17] 397120 0
Continuously throughout study duration
Secondary outcome [18] 399198 0
Percentage of time <3.9 mmol/L measured by continuous glucose monitor (CGM)
Timepoint [18] 399198 0
2 weeks before study commencement (Week -2 to 0), Week 10 to 12 and Week 22 to 24 post-intervention commencement
Secondary outcome [19] 399199 0
Percentage of time >10 mmol/L measured by continuous glucose monitor (CGM)
Timepoint [19] 399199 0
2 weeks before study commencement (Week -2 to 0), Week 10 to 12 and Week 22 to 24 post-intervention commencement
Secondary outcome [20] 399305 0
Frequency of education based on documentation of dates of the education sessions
Timepoint [20] 399305 0
During the dietician visits 4 weeks before the intervention (Week -4 to -2), and the start of intervention (Week 0)
For Arm 1, this will also occur 12-weeks post intervention (Week 12)
Secondary outcome [21] 399306 0
Percentage of time >13.9 mmol/L measured by continuous glucose monitor (CGM)
Timepoint [21] 399306 0
2 weeks before study commencement (Week -2 to 0), Week 10 to 12 and Week 22 to 24 post-intervention commencement
Secondary outcome [22] 399307 0
Percentage of time <2.8 mmol/L measured by continuous glucose monitor (CGM)
Timepoint [22] 399307 0
2 weeks before study commencement (Week -2 to 0), Week 10 to 12 and Week 22 to 24 post-intervention commencement
Secondary outcome [23] 399308 0
Mean glucose measured by continuous glucose monitor (CGM)
Timepoint [23] 399308 0
2 weeks before study commencement (Week -2 to 0), Week 10 to 12 and Week 22 to 24 post-intervention commencement

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed through central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Arm 1: 12 weeks of usual care, followed by 12 weeks of using Omnipod-DASH insulin pump
Arm 2: 24 weeks of Omnipod-DASH insulin pump

Participants will be randomised to continue their usual care or commence on the Omnipod-DASH insulin pump at the start of the intervention (Week 0) for 12 weeks. Then, both arms will be on the Omnipod-DASH insulin pump for another 12 weeks as an extension.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The exploratory nature of the study precludes a power calculation. N=64 participants will provide exploratory data across clinical sites and insulin delivery modalities (MDI and IPT). The primary analyses will assess differences between baseline and week 12 in the DTQ change score of participants. This will be done on the basis of intention to treat using analysis of covariance (ANCOVA), with adjustment for baseline baseline patient characteristics. A p-value of <0.05 will be considered statistically significant. Residuals will be explored to assess model fit. If model fit is poor, non-parametric analysis will be performed instead.
Continuous secondary and tertiary outcomes will be assessed using ANCOVA, count outcomes will be assessed using a Poisson or negative binomial regression model and for binary outcomes, logistic regression models will be fitted.
A subgroup analysis will be conducted by baseline insulin delivery mode in the form of an interaction term in the regression model or by stratifying analysis if non-parametric methods are required.
There will be no adjustment for multiple comparisons, all primary, secondary and tertiary outcome results will be reported. No interim analyses are planned.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19790 0
St Vincent's Private Hospital - Fitzroy
Recruitment hospital [2] 19791 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 19792 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 19927 0
Geelong Endocrinology and Diabetes Services - Geelong
Recruitment postcode(s) [1] 34437 0
3065 - Fitzroy
Recruitment postcode(s) [2] 34438 0
3084 - Heidelberg
Recruitment postcode(s) [3] 34439 0
3050 - Parkville
Recruitment postcode(s) [4] 34629 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 308921 0
Commercial sector/Industry
Name [1] 308921 0
Insulet Australia Pty Ltd
Address [1] 308921 0
Level 16, Tower 2 Darling Park, 201 Sussex Street, Sydney, NSW 2000
Country [1] 308921 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
41 Victoria Parade, Fitzroy, Victoria 3065
Country
Australia
Secondary sponsor category [1] 309842 0
None
Name [1] 309842 0
Address [1] 309842 0
Country [1] 309842 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308812 0
St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC)
Ethics committee address [1] 308812 0
41 Victoria Parade Fitzroy VIC 3065
Ethics committee country [1] 308812 0
Australia
Date submitted for ethics approval [1] 308812 0
19/05/2021
Approval date [1] 308812 0
23/06/2021
Ethics approval number [1] 308812 0
HREC 101/21

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111978 0
Prof David O'Neal
Address 111978 0
St Vincent’s Hospital (Melbourne)
41 Victoria Parade Fitzroy VIC 3065
Country 111978 0
Australia
Phone 111978 0
+61 425731665
Fax 111978 0
Email 111978 0
dno@unimelb.edu.au
Contact person for public queries
Name 111979 0
Dr Yee Wen Kong
Address 111979 0
St Vincent’s Hospital (Melbourne)
41 Victoria Parade Fitzroy VIC 3065
Country 111979 0
Australia
Phone 111979 0
+61 433593020
Fax 111979 0
Email 111979 0
kongyw@unimelb.edu.au
Contact person for scientific queries
Name 111980 0
Prof David O'Neal
Address 111980 0
St Vincent’s Hospital (Melbourne)
41 Victoria Parade Fitzroy VIC 3065
Country 111980 0
Australia
Phone 111980 0
+61 425731665
Fax 111980 0
Email 111980 0
dno@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results