The association between a modified carbohydrate diet, quality of life and glycaemic control in Australian adults with type 1 diabetes mellitus: A pilot study

Intervention group: Pre-study procedure: Participants will commence the study in a “rolling- start” manner rather than as a cohort of 23 to assist the management of participants. This will be the same for both intervention and matched controls group. For the intervention group, one week prior to the commencement of the intervention, participants who have never used a continuous glucose monitor (CGM) will be taught how to insert and use the CGM. Participants will also be reminder how to treat a hypoglycaemia to ensure correct management during the intervention in case this occurs. Study procedure: Intervention group: On the participants’ first day of the intervention, the participant’s weight and height will be recorded. Participants will complete the online participant information and consent form (PICF) and Australian Diabetes Specific Quality of Life Questionnaire at baseline. Weight will be recorded at the end of the study and the questionnaire will be re-administered at the end of week 13. Also, at the end of the study, each participant will be asked five questions regarding their perception/acceptance in relation to their quality of life, glycaemic control, the benefits and barriers of using the CGM. HbA1c will be recorded from pathology results at the commencement. Similarly, the follow up HbA1c will recorded at the end of the intervention. HbA1c will be measured in a NATA accredited laboratory. Participants will be provided with CGM kit at this time. All participants will be given an information kit with the following contents: • The study procedure; • Contact details of the diabetes dietitian, endocrinologist, credential diabetes educator, Gold Coast University Hospital Emergency Department; • Food, blood glucose level and exercise diary; • Sick day management plan; • Support services (in the case they experience any psychological distress during the study) and • Participant withdrawal form. Diet: Meal plans will be developed for each participant to meet their energy needs as per the Schofield formula (Schofield, 1985) and a macronutrient distribution of 20% for carbohydrate, 25% for protein and 55% for fat. This macronutrient distribution is similar to other studies where a low carbohydrate diet has been used (Ireland et al., 1992; Nielsen et al., 2005; Schmidt et al., 2019). Meals will not be provided to participants. Each participant will be provided with a tailored meal plan as per their total energy needs. Participant food likes and dislikes will be taken into account prior to developing the specific meal plan to reduce dietary boredom and/or fatigue. On day one of the study, the participants will meet with diabetes dietitian and be provided with their specific dietary meal plans. Participants will be advised the importance of adhering to the meal plans to ensure accuracy of study outcomes. Any treatment for hypoglycaemia is to be recorded by the participant i.e. when, what and how much carbohydrate was used to treat the hypoglycaemic event. Diabetes dietitian follow up consultation via telephone will occur at week 2, 4, 6, 8, 10 to determine if the participant has any questions or concerns about the dietary intake and to troubleshoot any problems. Participants will be able to contact the diabetes dietitian via phone or email at any time if they have any questions or concerns. Participants will be encouraged to contact the Endocrinologist or CDE at any time via telephone or email if they have any questions or concerns about their blood glucose levels, CGM and/or feel their insulin needs adjusting. Once a week during the 12-week intervention phase, participants will be required to perform a blood ketone test the morning after an overnight fast. Participants will be provided with a sick day management plan and if feeling unwell should contact the Endocrinologist or CDE for advice immediately.