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Trial registered on ANZCTR


Registration number
ACTRN12619000373178
Ethics application status
Approved
Date submitted
18/02/2019
Date registered
11/03/2019
Date last updated
7/02/2023
Date data sharing statement initially provided
11/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Counting the carbohydrate, fat and protein. A novel smartphone insulin bolus calculator to simplify mealtime insulin dosing in Type 1 Diabetes.
Scientific title
Counting the carbohydrate, fat and protein. A novel smartphone insulin bolus calculator to simplify mealtime insulin dosing in Type 1 Diabetes.
Secondary ID [1] 297423 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 311611 0
Condition category
Condition code
Metabolic and Endocrine 310237 310237 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants on the intervention arm will use the insulin bolus calculator, OptimAAPP to calculate their mealtime insulin dose for all meals and snacks for a period of three months. Education on OptimAAPP use will be administered by a diabetes educator in conjuction with a dietician, technical support will be provided by the OptimAAPP developer in conjuction with members of the study team. OptimAAPP setup will be overseen by the nominated site endocrinologist. Participants will receive on- going support from the study team in the form of a phone call at the end of weeks 1, 3,5,7,9 and 11.
Whilst participants will be instructed to use OptimAAPP for all meal bolus calculations this will not be monitored during the intervention. At the conclusion of the study OptimAAPP usage data will be exported in the form of a report.
There will be a two- week washout period between study arms.
Intervention code [1] 313689 0
Treatment: Devices
Comparator / control treatment
Participants on the control arm will continue using their usual method of mealtime insulin dose calculation, carbohydrate counting for a period of 3 months.
Control group
Active

Outcomes
Primary outcome [1] 319130 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 for mealtime bolus calculations compared to standard care, using carbohydrate counting.
Timepoint [1] 319130 0
Participant interstitial glucose levels will be measured for 4 non- continuous weeks (weeks 3,4 each study arm) using the Dexcom G5 mobile® continuous glucose monitoring system.
Secondary outcome [1] 367063 0
• Change in HbA1c, as assessed using capillary whole blood on a point of care DCA analyser.

Timepoint [1] 367063 0
Collected at 3 time points- baseline and at the end of each study arm (+12 weeks and +24 weeks)
Secondary outcome [2] 367211 0
time spent in hypoglycaemia
Timepoint [2] 367211 0
defined as sensor glucose less than 3.5 mmol/ L assessed for 3 non- continuous weeks (weeks 4, 8 12)/ arm (6 non- continuous weeks total) using continuous glucose monitoring.

Eligibility
Key inclusion criteria
Aged between 12- 50 years
HbA1c less than or equal to 10% (86 mmol/mol)
Type 1 Diabetes for more than 1 year
Managed with multiple daily injections and insulin
Minimum age
12 Years
Maximum age
50 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)
Allocation is not concealed
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Differences between conditions in the primary outcome variable will be assessed using a linear mixed model. The model will include fixed effects for time, order, and condition, and a random effect for participant. Analyses will follow the intention to treat principle.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/03/2019
Actual
24/06/2019
Date of last participant enrolment
Anticipated
1/12/2020
Actual
2/12/2020
Date of last data collection
Anticipated
30/06/2021
Actual
24/08/2021
Sample size
Target
48
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 13177 0
John Hunter Children's Hospital - New Lambton
Recruitment hospital [2] 13178 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 25731 0
2305 - New Lambton
Recruitment postcode(s) [2] 25732 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 301994 0
Charities/Societies/Foundations
Name [1] 301994 0
Australian Diabetes Educator Association (ADEA) Diabetes Research Foundation Ltd
Country [1] 301994 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Dr, Callaghan, NSW, Australia, 2308
Country
Australia
Secondary sponsor category [1] 301792 0
None
Name [1] 301792 0
Address [1] 301792 0
Country [1] 301792 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302669 0
Hunter New England Research Ethics Committee
Ethics committee address [1] 302669 0
The Lodge, Rankin Park Campus, Lookout Road, New Lambton NSW, Australia 2305
Ethics committee country [1] 302669 0
Australia
Date submitted for ethics approval [1] 302669 0
31/01/2019
Approval date [1] 302669 0
02/04/2019
Ethics approval number [1] 302669 0
2019/ETH00068

Summary
Brief summary
The proposed trial aims to determine if the use of a novel smartphone insulin bolus calculator, “OptimAAPP” which calculates insulin for carbohydrate, fat and protein in meals improves blood glucose levels in comparison to usual care (insulin dosing for carbohydrate only). We hypothesise that OptimAAPP will improve blood glucose control in people with Type 1 Diabetes (T1D) using multiple daily injection therapy, as measured by an increase in time spent in a blood glucose target range of 3.9-10.0mmol/L without an increase in time spent in hypoglycaemia compared to usual care.
Trial website
Trial related presentations / publications
Public notes
None

Contacts
Principal investigator
Name 91006 0
Dr Carmel Smart
Address 91006 0
Dept of Paediatric Endocrinology, John Hunter Children's Hospital, Lookout Rd New Lambton Heights, NSW, 2305
Country 91006 0
Australia
Phone 91006 0
+61 401624294
Fax 91006 0
Email 91006 0
[email protected]
Contact person for public queries
Name 91007 0
Tenele Smith
Address 91007 0
Hunter Medical Research Institute, lot 1 Kookaburra Ct, New Lambton Heights, NSW, 2305
Country 91007 0
Australia
Phone 91007 0
+61 400416577
Fax 91007 0
Email 91007 0
[email protected]
Contact person for scientific queries
Name 91008 0
Tenele Smith
Address 91008 0
Hunter Medical Research Institute, lot 1 Kookaburra Ct, New Lambton Heights, NSW, 2305
Country 91008 0
Australia
Phone 91008 0
+61 400416577
Fax 91008 0
Email 91008 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1401Study protocol    376987-(Uploaded-18-02-2019-18-15-04)-Study-related document.docx
7235Ethical approval    376987-(Uploaded-23-01-2020-15-14-53)-Study-related document.pdf



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.