None listed
Conditions
Brief summary
Type 2 Diabetes (T2D) is a chronic condition characterised by high blood glucose levels brought about due to the inability of the body to produce and/or use insulin. Obesity and poor lifestyle choices are the dominant risk factors for developing T2D and its related complications. The current management of T2D relies heavily on the health care sector to prescribe and manage medication, under the premise that T2D is chronic and progressive. New research on T2D has shown that low carbohydrate diets and lifestyle modifications can lead to improvements in blood glucose levels, as well as weight loss, reduction in the use of medications, and over time effectively put T2D into “remission”. Over the last two decades, technological advances have led to the development of health-related applications (apps) including a high proportion dedicated to the management of diabetes. Given the rate of adoption of smart phone usage these apps provide enormous potential to support the management of T2D. At present there are only a limited number of studies providing evidence on the effectiveness of using an app for the management of T2D. This research project seeks to address the knowledge gap and discover if there is evidence to support a low carbohydrate diet and lifestyle intervention delivered via the Defeat Diabetes Application (DDA).
Interventions
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.
Sponsors
Study design
Eligibility
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
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