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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.

Counting the Carbohydrate, Fat and Protein. A novel smartphone insulin dosing app to simplify mealtime insulin dosing using insulin pumps in Type 1 Diabetes.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000586910
Enrollment
48
Registered
2020-05-21
Start date
2020-08-31
Completion date
2021-02-26
Last updated
2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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 sess

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.

Sponsors

Hunter Medical Research Institute
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years
Healthy volunteers
No

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

Exclusion criteria

Complications of diabetes (e.g. gastroparesis) Any other major medical condition

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026