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Trial registered on ANZCTR


Registration number
ACTRN12620000586910
Ethics application status
Approved
Date submitted
27/03/2020
Date registered
21/05/2020
Date last updated
21/05/2020
Date data sharing statement initially provided
21/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A novel smartphone insulin dosing app to incorporate fat and protein into mealtime insulin dosing for children and adolescents with Type 1 diabetes using insulin pumps.
Scientific title
Counting the Carbohydrate, Fat and Protein. A novel smartphone insulin dosing app to simplify mealtime insulin dosing using insulin pumps in Type 1 Diabetes.
Secondary ID [1] 300877 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 316805 0
Condition category
Condition code
Metabolic and Endocrine 315017 315017 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be using an insulin calculator called optimAAPP that will incorporate fat and protein amounts along with carbohydrate in order to calculate an appropriate insulin dose

-The intervention will be personalised based on the participants current diabetes management. This will be done during the run-in period which will take place over 2 weeks before each intervention. This will also work as a wash-out period
- Each participant will be provided with a fat and protein education session that has been developed by the diabetes team. Participants will also be demonstrated on use of the insulin calculator through a face to face education session along with instructional videos to watch
- For 3 months the participant will use their current method of insulin calculation for their meals and for the other 3 months they will use our insulin calculator to determine their insulin needs for each meal.
- They will attended several education sessions with our Senior diabetes dietitian in order to ensure they are given appropriate and effective information.
- They will have face to face sessions with the research team at the beginning, middle and end of the trial. Along with regular phone contact with a research coordinator throughout.
- This trial will take place in a free living environment.

1. During the run-in period will involve daily BGL monitoring and consultation with endocrinologist to ensure the participant is receiving suitable insulin doses

2. Fat and protein education will be provided by a dietitian

3. Education session will be roughly an hour

4. We have made the instructional videos mandatory to ensure the education session will go smoothly and can come with any questions they may have

5. The instructional videos were designed specifically by our team for this study

6. The education session has two standardised work sheets to determine participant competency with fat and protein. Depending on participants knowledge with this will determine how much education they will require until considered proficient by the dietitian.

7. Face to face sessions will be used for fat and protein education. Initial set up and training on how to use optimAAPP. Along with sensor insertion and surveys when required.

8. We are able to analyse data from the app to determine how often they are using to to calculate insulin and this can be compared with pump downloads.
Intervention code [1] 317203 0
Treatment: Devices
Comparator / control treatment
Each participant will be monitored whilst they are using their current method of insulin calculation this will be a period of 3 months which is the same time they will be using the new insulin calculator. This is will allow us to compare with our insulin calculator intervention and each participant will be their own control
Control group
Active

Outcomes
Primary outcome [1] 323317 0
The primary outcome variable is to compare the proportion of time spent in target glucose range (3.9- 10 mmol/L) while using OptimAAPP compared to standard care.

This will be done using a continuous glucose monitor.
Timepoint [1] 323317 0
6 months. 3 months on each condition
Secondary outcome [1] 381541 0
Change in HbA1c measured using HbA1c analyser located in our clinic.
Timepoint [1] 381541 0
baseline and 12 weeks post intervention
Secondary outcome [2] 381542 0
Hypoglycaemic events defined as sensor glucose values < 3.9mmol/L for >15 minutes. This will be measured using a continuous glucose monitor.
Timepoint [2] 381542 0
end of each 3 month period
Secondary outcome [3] 381543 0
Glycaemic variability defined as Mean Amplitude of Glycaemic Excursions (MAGE) and Co- efficient of Variation (CV). This will be measured using a continuous glucose monitor.
Timepoint [3] 381543 0
baseline and 12 weeks post intervention
Secondary outcome [4] 381544 0
questionnaires on fat and protein knowledge (they have been developed by our clinical diabetes team)

It is a composite secondary outcome
Timepoint [4] 381544 0
Baseline and post study (6 months)
Secondary outcome [5] 381545 0
Qualitative assessment of OptimAAPP user experience.

This will be done through a questionnaire we have developed that will be given to the participants.
Timepoint [5] 381545 0
post intervention (6 months)

Eligibility
Key inclusion criteria
Aged between 12- 18 years
HbA1c less than 10% (86 mmol/mol)
Type 1 Diabetes greater than 1 year
Managed with insulin pump therapy
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Complications of diabetes (e.g. gastroparesis)
Any other major medical condition

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2020
Actual
Date of last participant enrolment
Anticipated
26/02/2021
Actual
Date of last data collection
Anticipated
31/08/2021
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16158 0
John Hunter Children's Hospital - New Lambton
Recruitment postcode(s) [1] 29700 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 305326 0
Other Collaborative groups
Name [1] 305326 0
Hunter Medical Research Institute
Country [1] 305326 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Hunter Medical Research Institute
Address
Lot 1, Kookaburra Cct, New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 305695 0
None
Name [1] 305695 0
Address [1] 305695 0
Country [1] 305695 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305664 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 305664 0
Lot 1, Kookaburra Cct, New Lambton Heights NSW 2305
Ethics committee country [1] 305664 0
Australia
Date submitted for ethics approval [1] 305664 0
Approval date [1] 305664 0
20/03/2020
Ethics approval number [1] 305664 0

Summary
Brief summary
The proposed study is a non- blinded, randomised, cross-over trial to be conducted at John Hunter Children's Hospital, Newcastle under free living conditions. The aim of this study is to determine if a smartphone insulin bolus calculator, “OptimAAPP” which calculates insulin for carbohydrate, fat and protein improves glycaemia in people with type 1 diabetes (aged 12- 18 yrs) in comparison to usual care (insulin dosing for carbohydrate only). Participants (n= 48) will be randomised to use OptimAAPP to calculate their meal- time insulin doses or continue to use carbohydrate counting to calculate their meal- time insulin doses (usual care) for 3 months and then cross-over to the alternate condition. To assess the relative efficacy of each method of insulin dosing in managing glycaemia participant interstitial glucose levels will be measured remotely using a continuous glucose monitor for six- non continuous weeks (3 weeks/study arm).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101142 0
Dr Carmel Smart
Address 101142 0
Department of Endocrinology and Diabetes
John Hunter Children's Hospital
Lookout Road, New Lambton Heights, NSW, AUS, 2305
Country 101142 0
Australia
Phone 101142 0
+61 0401 624 294
Fax 101142 0
Email 101142 0
[email protected]
Contact person for public queries
Name 101143 0
Jordan Rafferty
Address 101143 0
Hunter Medical Research Institute, Lot 1, Kookaburra Cct, New Lambton Heights NSW 2305
Country 101143 0
Australia
Phone 101143 0
+61 0403106451
Fax 101143 0
Email 101143 0
[email protected]
Contact person for scientific queries
Name 101144 0
Jordan Rafferty
Address 101144 0
Hunter Medical Research Institute, Lot 1, Kookaburra Cct, New Lambton Heights NSW 2305
Country 101144 0
Australia
Phone 101144 0
+61 0403106451
Fax 101144 0
Email 101144 0
[email protected]

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 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.