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Trial registered on ANZCTR


Registration number
ACTRN12622000710729
Ethics application status
Approved
Date submitted
6/05/2022
Date registered
17/05/2022
Date last updated
21/02/2023
Date data sharing statement initially provided
17/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of the effectiveness of the Defeat Diabetes Application (DDA) low carbohydrate diet and lifestyle intervention, in the self-management of type 2 diabetes.
Scientific title
Effectiveness of digitally delivered continuous care intervention on the self management of type 2 diabetes. A 12-month single-arm, pre-post intervention study.
Secondary ID [1] 307070 0
Nil known
Secondary ID [2] 307615 0
Defeat Diabetes Research Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 326225 0
Condition category
Condition code
Diet and Nutrition 323526 323526 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 323527 323527 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention requires the participants to follow the recommendations outlined in the Defeat Diabetes Application in order to make dietary and lifestyle changes over a 12-month period.
The Defeat Diabetes Application (DDA) is a subscription based commercial application for download on smartphone (Android and Apple OS). The DDA provides a guided educational program on specific low carbohydrate and lifestyle interventions to manage T2D.

This success of this study is heavily reliant on the support of community based GPs (who agree to help by signing a letter of support). Supporting GPs can then refer potential participants who they medically manage, with a diagnosis of Type 2 Diabetes (T2D) to the research team.
Members of the Royal Australian College of General Practitioners (RACGP) who support the research will be eligible for RACGP CPD Accredited Activity Self Directed - GP Group Research on completion of the study.
(A process evaluation survey addressing the requirements of the RACGP will be provided to supporting GPs at the completion of the study.)

Members of the Australian College of Rural and Remote Medicine (ACRRM), who participate may be eligible for CPD. This study is an accredited as an Educational Activity and an Outcome Measurement Activity.

After referral by their GP, screening for eligibility, consent to participate and baseline measurements are received, participants will be given free lifetime access to the Defeat Diabetes App, where they can access educational resources and a private Defeat Diabetes Facebook community group. (GPs who express interest in the study will also receive free lifetime access to the DDA and related resources.)

When participants first visit their GP, they will be asked to undergo laboratory bloodwork tests, blood pressure, waist circumference, height and weight measurements. Data will also need to be recorded at 3, 6 and 12 months by the participants GP and forwarded to the research team (with participants consent).

The research team will also send participants a set of online survey questionnaires at baseline, 3, 6 and 12 months, that will assess their physical activity levels, sleep, quality of life, diabetes distress and self-efficacy, adverse events reporting and in addition keep a record (for 3 days) of their dietary intake. At 12 months they will also be asked to complete a post evaluation survey about their knowledge and experiences throughout the study period.

Supporting GPs will be responsible for the referral and medical management of participants throughout the study period.
After their initial consultation and baseline measurements, the time commitment required by participants will be 3 visits to their GP (where bloodwork, blood pressure and measurements will be collected), completion of a set of questionnaires (taking no more than 15 minutes) and a 3 day food records (no more than ½ hour to complete) at 3, 6 and 12 months of the study period.

Intervention
This intervention requires the participants to follow the recommendations outlined in the Defeat Diabetes Application in order to make dietary and lifestyle changes over a 12-month period.
The Defeat Diabetes Application (DDA) is a subscription based commercial application for download on smartphone (Android and Apple OS). The DDA provides a guided educational program on specific low carbohydrate and lifestyle interventions to manage T2D.
On recruitment and receipt of the baseline reporting measures, participants will be given free lifetime access to the DDA. Defeat Diabetes will send an email link to participants with instructions explaining how to access and install the application. Participants will then be able to use the educational material provided at their convenience. All educational resources are time stamped so that users are aware of the level of detail and time required to complete each section.
The educational material and resources of the DDA consists of:
1. Structured video lessons and masterclasses
Lessons are structured to introduce and describe the main features of using a low carbohydrate diet and lifestyle changes for management of T2D and contain practical strategies for implementation. The 13 lessons vary in time from 6-13 minutes duration and require approximately 100 minutes to view the content in full. The 25 Masterclasses provide greater detail on selected topics and range in time from 3-13 minutes duration (approximately 180 minutes in total).
2. Articles
Short articles that address some common questions around nutrition and lifestyle such as meal planning and exercise recommendations, including work out plans with video instructions.
3. Low carbohydrates recipes and cooking demonstrations
Recipes and video demonstrations for breakfasts, lunch, dinner, drinks, snacks, sides and sweet treats are included. These are further separated into categories such as Dairy Free, Gluten Free, Keto, Vegetarian and seasonal categories.
4. Meal planning, shopping list and exercise plans
Detailed weekly plans for weekly meals utilising featured recipes and providing the facility of a shopping list to streamline meal preparation process. Also included are exercise and workout plans for multiple levels of fitness and abilities with videos elaborating on specific movement.
5. Access to an interactive private DDA Community Facebook group
Questions and answers can be posted and support provided during the transition to a low carbohydrate diet. Once a month real time events are also scheduled that typically consist of interviews or live Q&A sessions.
The research team will follow up participants at 2 weeks after recruitment via phone consultation to ensure that the there are no technical issues with using the DDA and that they have been able to access the private DDA Community Facebook group. Further follow up via email/or text messaging will occur in weeks 4 and 8 to answer/follow up any participant questions on DDA accessibility issues. Participants will be able to interact with the private DDA Community Facebook group (moderated by Defeat Diabetes) as required for additional support.
Intervention code [1] 323523 0
Lifestyle
Comparator / control treatment
No control group,
Participants are referred to the study via their GP, The expectation is that pre- enrolment, participant GP management would be in line with the Royal Australian College of General Practitioners (RACGP) clinical guidelines for management of type 2 diabetes (Management of type 2 diabetes: A handbook for general practice).
It is stated in the inclusion criteria that the participants are to have type 2 diabetes and should not being using the Defeat Diabetes app OR using a low carbohydrate diet to manage their type 2 diabetes to be included in the study..
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331323 0
HbA1c assessed by blood test
Timepoint [1] 331323 0
Baseline, 3, 6 and 12 months (primary timepoint) post-intervention commencement
Secondary outcome [1] 409423 0
Insulin resistance (as measured by TRIG/HDL ratio, waist to height ratio) assessed by blood tests and anthropometry
Timepoint [1] 409423 0
Baseline, 6 and 12 months post-intervention commencement
Secondary outcome [2] 409521 0
Serum lipid biomarkers (TC, HDL-c, LDL-c, TRIG) assessed by blood test
Timepoint [2] 409521 0
Baseline, 6 and 12 months post-intervention commencement
Secondary outcome [3] 409522 0
Liver function (ALT, GGT) assessed by blood test. This is optional - and by discretion of GP who is collecting data at each time point.
Timepoint [3] 409522 0
Baseline, 6 and 12 months post-intervention commencement
Secondary outcome [4] 409523 0
Renal function (eGFR) assessed by blood test
Timepoint [4] 409523 0
Baseline, 6 and 12 months post-intervention commencement
Secondary outcome [5] 409524 0
Inflammation as measured by (CRP) OR (hs-CRP) assessed by blood test. This is optional - and by discretion of GP who is collecting data at each time point.
Timepoint [5] 409524 0
Baseline, 6 and 12 months post-intervention commencement. This is optional - and by discretion of GP who is collecting data at each time point.
Secondary outcome [6] 409525 0
Body weight, waist circumference, BMI, Waist to height ratio,
GPs will collect anthropometric data (stadiometer and scales available in GP practice setting)
Timepoint [6] 409525 0
Baseline, 3, 6 and 12 months post-intervention commencement
Secondary outcome [7] 409526 0
Blood pressure
GPs will collect blood pressure data (sphygmomanometer in a practice setting)
Timepoint [7] 409526 0
Baseline, 3, 6 and 12 months post-intervention commencement
Secondary outcome [8] 409528 0
Changes to prescribed medications and dose using a report generated by the GP practice patient management software
Timepoint [8] 409528 0
Baseline, 3, 6 and 12 months post-intervention commencement
Secondary outcome [9] 409529 0
Using Brief Pittsburgh Sleep Quality Index (BPSQI) questionnaire
Timepoint [9] 409529 0
Baseline, 3, 6 and 12 months post-intervention commencement
Secondary outcome [10] 409530 0
QOL using EQ-5D –5L a standardised measure of health status for clinical and economic appraisal (The EuroQol Group, 1990)
Timepoint [10] 409530 0
Baseline, 3, 6 and 12 months post-intervention commencement
Secondary outcome [11] 409531 0
Diabetes related emotional distress using the PAID-5 questionnaire
Timepoint [11] 409531 0
Baseline, 3, 6 and 12 months post-intervention commencement
Secondary outcome [12] 409532 0
Self-efficacy in managing T2D using the Perceived Diabetes Self-Management Score (PDSMS)(American Diabetes Association, 2005)
Timepoint [12] 409532 0
Baseline, 3, 6 and 12 months post-intervention commencement
Secondary outcome [13] 412029 0
Fasting Blood Glucose
Timepoint [13] 412029 0
Baseline, 3, 6 and 12 months post-intervention completion
Secondary outcome [14] 412392 0
Diabetes Remission
Defined as :
“HbA1c < 6.5% (48 mmol/mol) measured at least 3 months after cessation of glucose-lowering pharmacotherapy”
This is a Yes/No question on an online survey tool that will be provided to the GP to collect data for primary and secondary outcome measures. It requires the GP to review medication and patient bloodwork since the 6 month data collection timepoint to assess if the definition of "remission" has been achieved.
Timepoint [14] 412392 0
This question will only be asked at 12 months post intervention commencement.

Eligibility
Key inclusion criteria
Willingness to participate, and visit their GP for measurements and bloodwork throughout the study period of 12 months
Adults (men and women) meeting the clinical diagnostic criteria for type 2 diabetes and have HbA1c of greater than or equal to 6.5%
Not currently using the DDA or using low carbohydrate diet to manage their type 2 diabetes
Have a smartphone and can use digital technology (download and install digital application)
Signed informed consent to participate in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to understand written and spoken English
Younger than 18 years of age
Unwilling to participate in 12-month intervention
Liver disease (other than metabolic associated fatty liver disease) or secondary causes of MAFLD and cirrhosis
Renal failure and patients undertaking dialysis
Have a diagnosis of Type 1 diabetes or Latent Autoimmune Diabetes in Adults (LADA)
Are pregnant
Are using insulin to manage their Type 2 diabetes
Prescribed a SGLT2 inhibitor and fasting insulin < 10mU/L
Excluded from participating for existing medical conditions at the discretion of their GP

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation has been conducted with the use of G*Power version 3.1.9.7. All statistical analysis will be performed using SSPS software (IBM SSPS Statistics for Windows, Version 25.0 Armonk, NY: IBM Corp.)
ANOVA or the non-parametric Kruskal-Wallis analysis will be used to examine the differences among the different time points.
Mixed-models analyses to examine within-group changes from baseline to follow-up and between- group differences amongst subgroups, taking into consideration random effect factors and confounding factors.
Correlations will be used to explore the relationship between questionnaires and biological sample data.
3-day food record data may be used to stratify participants into groups based on adherence to low carbohydrate diet.
All reported P-values will be two-tailed, while the level of statistical significance will be set at P<0.05.
Post hoc analysis may categorise participants into subgroups of/but not limited to:
• Fasting blood glucose level and HbA1c on recruitment
• Carbohydrate consumption - analysis of 3-day food record
• Physical activity level
• Level of support provided by GP or alternative resources (internet/other)
• Interaction with DDA resources

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/10/2022
Actual
18/09/2022
Date of last participant enrolment
Anticipated
2/10/2023
Actual
Date of last data collection
Anticipated
2/10/2024
Actual
Sample size
Target
100
Accrual to date
49
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311379 0
Commercial sector/Industry
Name [1] 311379 0
Defeat Diabetes
Country [1] 311379 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Defeat Diabetes
Address
Level4/100 Albert Road South Melbourne 3205 VIC
Country
Australia
Secondary sponsor category [1] 312768 0
University
Name [1] 312768 0
La Trobe University
Address [1] 312768 0
La Trobe University
Melbourne VIC 3086

Country [1] 312768 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310865 0
La Trobe University HREC
Ethics committee address [1] 310865 0
Ethics committee country [1] 310865 0
Australia
Date submitted for ethics approval [1] 310865 0
02/05/2022
Approval date [1] 310865 0
11/07/2022
Ethics approval number [1] 310865 0
HREC approval ID 'HEC22117'

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

Contacts
Principal investigator
Name 119146 0
Prof George Moschonis
Address 119146 0
Department of Food, Nutrition and Dietetics
School of Allied Health, Human Services and Sport
La Trobe University Bundoora VIC 3086
Office location: Health Sciences Building 3, Room 216
Country 119146 0
Australia
Phone 119146 0
+61394793482
Fax 119146 0
Email 119146 0
g.moschonis@latrobe.edu.au
Contact person for public queries
Name 119147 0
George Moschonis
Address 119147 0
Department of Food, Nutrition and Dietetics
School of Allied Health, Human Services and Sport
La Trobe University Bundoora VIC 3086
Office location: Health Sciences Building 3, Room 216
Country 119147 0
Australia
Phone 119147 0
+61394793482
Fax 119147 0
Email 119147 0
g.moschonis@latrobe.edu.au
Contact person for scientific queries
Name 119148 0
George Moschonis
Address 119148 0
Department of Food, Nutrition and Dietetics
School of Allied Health, Human Services and Sport
La Trobe University Bundoora VIC 3086
Office location: Health Sciences Building 3, Room 216
Country 119148 0
Australia
Phone 119148 0
+61394793482
Fax 119148 0
Email 119148 0
g.moschonis@latrobe.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
For ethical reasons, individual data will not be publicly available.


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
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of a Digitally Delivered Continuous Care Intervention (Defeat Diabetes) on Type 2 Diabetes Outcomes: A 12-Month Single-Arm, Pre-Post Intervention Study.2023https://dx.doi.org/10.3390/nu15092153
N.B. These documents automatically identified may not have been verified by the study sponsor.