Low Carbohydrate Diet, Glycaemic Control and Quality of Life in Australian Adults With Type 1 Diabetes

Phase 1:

Aim: To develop a reliable and valid diabetes specific quality of life questionnaire for use in Australian adults living with type 1 diabetes mellitus (T1DM).

Objectives:

• To develop a new Australian diabetes specific quality of life online questionnaire integrating participant feedback using a one to one interview method;
• Pilot the study developed online questionnaire with adults that have type 1 diabetes mellitus and
• Conduct factorial validation of the study developed online questionnaire using advanced statistical modelling techniques.

Phase 2:

Aim: The aim of this study is to examine the association between a low carbohydrate diet, quality of life and glycaemic control in adults living with T1DM.

Objectives:

• To examine the association between quality of life and glycaemic control in adults with T1DM;
• Implement a low carbohydrate diet in a cohort of adults living with T1DM;
• Examine the association between a low carbohydrate diet and glycaemic control in adults with T1DM: pre and post intervention;
• Examine the association between quality of life and a low carbohydrate in adults with T1DM: pre and post intervention and
• Investigate whether a low carbohydrate diet mediates the relationship between quality of life and glycaemic control in adults with T1DM.

Inclusion criteria

• Male, female or unspecified gender;
• 18 years of age or over;
• Type 1 diabetes for ≥1 year from diagnosis date and
• Individuals who administer insulin using multiple daily injections.

Exclusion criteria

• Patients with type 2 diabetes mellitus;
• Patients with gestational diabetes mellitus;
• Presence of a known food allergy or intolerance that may affect the participants' health or adherence during the intervention;
• History of an eating disorder;
• BMI <25.0kg/m2 to 29.9kg/m2;
• Age <18 years;
• An active medical problem that may hinder the persons' ability to take part or potentially affect study outcomes e.g. a recent myocardial infarction, stroke or peripheral revascularisation (within 3 months), active treatment of diabetic retinopathy, recent serious infection (requiring in-hospital treatment or prolonged antibiotic therapy), active mental health complaint or other active medical problems determined by medical staff;
• Pregnancy or expectation of conceiving. Participants will be withdrawn at any stage from the study if pregnancy occurs;
• The use of medications that may affect body weight/body composition (including but not limited to phentermine and corticosteroids);
• Those for whom the written materials may be unsuitable such as vision impaired or illiterate individuals;
• Those unable to understand English;
• Those who failed to provide informed consent and
• Those who administer insulin using a continuous subcutaneous insulin infusion.