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Trial registered on ANZCTR


Registration number
ACTRN12624000275561
Ethics application status
Approved
Date submitted
31/01/2024
Date registered
18/03/2024
Date last updated
18/03/2024
Date data sharing statement initially provided
18/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a new blood glucose management software tool for people with type 2 diabetes mellitus
Scientific title
A novel digital glycaemic management tool for people with type 2 diabetes mellitus: a pilot study
Secondary ID [1] 311211 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 332400 0
Obesity 332401 0
Condition category
Condition code
Metabolic and Endocrine 329099 329099 0 0
Diabetes
Diet and Nutrition 329100 329100 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single-arm cross-over trial. The intervention is a novel digital glycaemic management tool that allows participants to track their dietary intake using text-based input or automated image-based input. Text-based input involves the participant text-searching a nutritional database. Automated image-based input uses the devices camera and the Passio Nutrition AI tool (Passio Inc., Palo Alto, US) that provides suggested food items based on machine learning recognition of images. The tool also integrates with a continuous glucose monitor to display the participant's blood glucose level alongside their dietary intake. This tool is novel and has been developed for this project. Participants will be instructed and educated on how to interpret the blood glucose curve to inform dietary decisions. Access to this tool and continuous glucose monitors will be provided for 20 days. Participants will be educated on the use of the application at the first study visit, prior to recording their dietary intake. Study visit one will take place immediately after the successful screening visit or at a later date, per the participants preference. This will involve how to download the application, creating an application profile, using the text-based input, using the image-based input, using additional application features such as favouriting items and creating custom food items. Study visit 2 takes place at least ten days after study visit 1. At study visit 2 participants will be shown how to connect, use, and interpret the continuous glucose monitor display. The education and instruction at study visit 1 will take approximately 45 minutes, and approximately 20 minutes at study visit 2. Adherence to the tool is assessed through a secondary objective: measured energy intake through the application compared to objectively measured energy expenditure. Adherence is promoted through the use of a novel prompting system that sends reminders to the users via their device notification system based on user-specific metrics; please see the protocol for full details. A secondary objective, measuring the intra-individual and inter-individual variability of post-prandial glycaemic responses, will be assessed by providing participants with a high GI meal and a low GI meal at three points at the study. This is to determine if participants have consistent post-prandial glycaemic reactions to meals, for example, a consistently larger post-prandial glycaemic response to the high GI meal versus the low GI meal, and if the differences between individuals are larger than the variation within individuals. One set of meals, that is, one low GI meal and high GI meal, will be provided at visit one, and two sets provided at visit two. Participants will be instructed to consume the meals within 10 minutes after an overnight fast without any accompanying food items. The low GI meal are wheat flakes, and the high GI meal is corn flakes. Analysis of inter- and intra-individual variation will proceed with analysis run and reported separately for low-GI and high-GI meals (as this is another source of variation in responding). This will use descriptive statistics (per-participant standard deviations of outcomes) and analysis using linear mixed models with a random intercept for each participant. These models will estimate intra-individual variation (akin to an average standard deviation across all participants) and inter-individual variation, with 95% confidence intervals for each. The same analysis will provide an intraclass correlation coefficient (ICC) expressing the relative contribution of intra-individual variation to the overall variation in outcomes.
Intervention code [1] 327669 0
Treatment: Devices
Comparator / control treatment
This is a single arm cross-over trial. Participants will undergo the control stage before the intervention stage. The control stage is the ten days following the day of study visit 1. In the control stage participants will use the digital glycaemic management tool to record their dietary intake and measure their blood glucose using the continuous glucose monitor; however, the participants will be blinded to the blood glucose readings. This is the same digital glycaemic tool, but with the glucose-tracking display disabled for the participant. The participant will still have access to the food-tracking features of the application.
Control group
Active

Outcomes
Primary outcome [1] 336917 0
Time-in-range
Timepoint [1] 336917 0
The time-in-range of 10 days of recording dietary intake and blinded blood glucose will be compared to the time-in-range of 20 days of recording dietary intake and unblinded blood glucose.
Primary outcome [2] 336918 0
Post-prandial incremental area-under-curve
Timepoint [2] 336918 0
The post-prandial incremental area-under-curve of 10 days of recording dietary intake and blinded blood glucose will be compared to the post-prandial incremental area-under-curve of 20 days of recording dietary intake and unblinded blood glucose.
Secondary outcome [1] 430152 0
Duration of post-prandial hyperglycaemia
Timepoint [1] 430152 0
The duration of post-prandial hyperglycaemia of 10 days of recording dietary intake and blinded blood glucose will be compared to the duration of post-prandial hyperglycaemia of 20 days of recording dietary intake and unblinded blood glucose.
Secondary outcome [2] 430155 0
Inter-individual variability of post-prandial incremental area-under-curve
Timepoint [2] 430155 0
One meal set will be provided at study visit 1, with one of the two meals in the meal set ingested at study visit 1. The final two sets will be provided at study visit 2, which takes place at least ten days following the day of study visit 1.
Secondary outcome [3] 430156 0
Intra-individual variability of post-prandial incremental area-under-curve
Timepoint [3] 430156 0
These meals will be provided at three time-points 10 days apart. The first time-point is at visit one (one day before the control period) where participants will be provided with one set of meals. One meal will be consumed at the visit, with the other provided for consumption in the next ten days, but participants will be asked to consume it the next day. At visit two (one day before the intervention period) users will be provided with two sets of meals, to be consumed during the next twenty days, but participants will be asked to consume the meals as soon as possible, ideally within the first four consecutive days.
Secondary outcome [4] 430157 0
Agreement between energy intake recorded by the tool and objectively measured energy expenditure. This is a composite secondary outcome.
Timepoint [4] 430157 0
Indirect calorimetry will be carried out at the baseline study visit. Accelerometery will be carried out over the ten days following this visit. Energy intake measurements from the tool from the ten days following the baseline study visit and the twenty days following the second study visit will be included in analysis.
Secondary outcome [5] 430158 0
Qualitative experience of using the application
Timepoint [5] 430158 0
The questionnaire will be administered at the final study visit (Visit 3), after the intervention period of twenty days is complete.

Eligibility
Key inclusion criteria
• Aged >=18 years
• Type 2 diabetes with an HbA1c 65-90 mmol/mol on any hypoglycaemic therapeutic regimen other than insulin.
o If the individual has a high baseline time-in-range, the potential improvements will be difficult to detect at smaller sample sizes, which necessitates selecting for those who have the greatest potential for benefit. Participants with an HbA1c >90 mmol/mol should have additional therapy initiated and will therefore be ineligible for this trial.
• Speaks and reads English
o Due to scope limitations, the application has only been developed in English
• Owns an iOS device capable of running iOS 16 and above
o These are the technical specifications required to use the application
• Able to consume dairy milk and gluten
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Type 1 diabetes or forms of diabetes other than type 2.
• Changes to diabetes-related medications or dosing in the last three months
• Insulin or intention to initiate insulin therapy during the trial
o Although this application may have future benefit to people living with diabetes who require insulin therapy, the use of insulin will make it difficult to assess the isolated effect of dietary change on glycaemic management.
• Intention to change dosage of anti-hyperglycaemic agents or initiate continuous glucose monitoring during the trial
• Pregnancy
• Participation in another trial requiring a prescriptive nutritional intake.
o As this study is examining the effect of changing nutritional intake informed by the application, the participant must be able to change their intake at will, which would contradict the trial requiring prescriptive nutritional intake.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Single group
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
29/03/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 26042 0
New Zealand
State/province [1] 26042 0
Wellington

Funding & Sponsors
Funding source category [1] 315470 0
Government body
Name [1] 315470 0
Health Research Council
Country [1] 315470 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
362 Leith Street, Dunedin North, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 317541 0
Hospital
Name [1] 317541 0
Te Whatu Ora, Capital and Coast
Address [1] 317541 0
69 Riddiford Street, Newtown, Wellington 6021
Country [1] 317541 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314379 0
Northern B Health and Disability Ethics Committees
Ethics committee address [1] 314379 0
Ethics committee country [1] 314379 0
New Zealand
Date submitted for ethics approval [1] 314379 0
15/11/2023
Approval date [1] 314379 0
22/11/2023
Ethics approval number [1] 314379 0
2023 EXP 18399

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131370 0
Dr Lachlan Lee
Address 131370 0
Department of Medicine, University of Otago Wellington, 23a Mein Street, Newtown, Wellington 6242
Country 131370 0
New Zealand
Phone 131370 0
+64 221597602
Fax 131370 0
Email 131370 0
[email protected]
Contact person for public queries
Name 131371 0
Lachlan Lee
Address 131371 0
Department of Medicine, University of Otago Wellington, 23a Mein Street, Newtown, Wellington 6242
Country 131371 0
New Zealand
Phone 131371 0
+64 221597602
Fax 131371 0
Email 131371 0
[email protected]
Contact person for scientific queries
Name 131372 0
Lachlan Lee
Address 131372 0
Department of Medicine, University of Otago Wellington, 23a Mein Street, Newtown, Wellington 6242
Country 131372 0
New Zealand
Phone 131372 0
+64 221597602
Fax 131372 0
Email 131372 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
This study does not have ethical approval for sharing individual data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21253Study protocol    387078-(Uploaded-19-12-2023-10-02-26)-Study-related document.docx



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.