Background Globally, the prevalence of type 1 diabetes mellitus (T1DM) is rising. In 2020, a total of 124,652 Australians had T1DM. Maintaining optimal glycemic control (hemoglobin A1c ≤7.0%, ≤53 mmol/mol) on a standard carbohydrate diet can be a challenge for people living with T1DM. The Diabetes Complications and Control Trial established that macrovascular and microvascular complications could be reduced by improving glycemic control. Recent studies have found that a very low or low carbohydrate diet can improve glycemic control. However, the overall evidence relating to an association between a very low or low carbohydrate diet and glycemic control in people living with T1DM is both limited and mixed. In addition, research has suggested that a reduced quality of life due to anxiety and depression adversely influences glycemic control. Despite a potential link between a very low or low carbohydrate diet and optimal glycemic control, to our knowledge, no research has examined an association between a low carbohydrate diet, quality of life, and glycemic control, making this study unique in its approach. Objective The study aims to develop a validated diabetes-specific quality of life questionnaire for use in Australian adults with T1DM and to determine if an association exists between a low carbohydrate diet, quality of life, and glycemic control in Australian adults living with T1DM. Methods This cross-sectional study will be conducted in a tertiary hospital outpatient setting and will consist of 3 phases: phase 1, online Australian diabetes-specific quality of life questionnaire development and piloting (25-30 adults with T1DM); phase 2, questionnaire validation (364 adults with T1DM); and phase 3, a 12-week dietary intervention to determine if an association exists between a low carbohydrate diet, quality of life, and glycemic control in adults with T1DM (16-23 adults with T1DM). The validation of the study-developed Australian diabetes-specific quality of life questionnaire, and changes in hemoglobin A1c and quality of life in adults with T1DM while undertaking a low carbohydrate diet over 12 weeks will be the primary outcomes of this study. Results Phase 1 of the study is currently open for recruitment and has recruited 12 participants to date. It is anticipated that the first results will be submitted for publication in November 2021. Presently, no results are available. Conclusions This study is the first of its kind in that it will be the first to generate a new validated instrument, which could be used in evidence-based practice and research to understand the quality of life of Australian adults with T1DM. Second, the low carbohydrate dietary intervention outcomes could be used to inform clinicians about an alternative approach to assist T1DM adults in improving their quality of life and glycemic control. Finally, this study could warrant the development of an evidence-based low carbohydrate dietary guideline for adults living with T1DM with the potential to have a profound impact on this population. Trial Registration ClinicalTrials.gov NCT04213300; https://clinicaltrials.gov/ct2/show/NCT04213300 International Registered Report Identifier (IRRID) PRR1-10.2196/25085

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BACKGROUND Globally, the prevalence of type 1 diabetes (T1DM) is rising. In 2020, 124,652 Australians had T1DM. Maintaining optimal glycemic control [HbA1c ≤7.0% (≤53 mmol/mol)] on a standard carbohydrate diet can be a challenge for people living with T1DM. The Diabetes Complications and Control Trial established that macrovascular and microvascular complications could be reduced by improving glycemic control. Recent studies have found that a very low or low carbohydrate diet can improve glycemic control. However, the overall evidence relating to an association between a very low or low carbohydrate diet and glycemic control in people living with T1DM is both limited and mixed. In addition, research has suggested that poor quality of life (QoL) due to anxiety and depression adversely influences glycemic control. Despite a potential link between a very low or low carbohydrate diet and good glycemic control, no research to our knowledge has examined an association between a very low or low carbohydrate diet, QoL and glycemic control, making this study unique in its approach. OBJECTIVE The study aims to: 1) develop a validated diabetes specific quality of life questionnaire for use in Australian adults with T1DM and 2) determine if an association exists between a low carbohydrate diet, quality of life and glycemic control in Australian adults living with T1DM. METHODS This cross-sectional study will be conducted in a tertiary hospital outpatient setting and will consist of three phases. Phase 1, online Australian diabetes specific quality of life questionnaire development and piloting (n=25-30 T1DM adults); Phase 2, questionnaire validation (n=364 T1DM adults) and Phase 3, a 12-week dietary intervention to determine if an association exists between a low carbohydrate diet, QoL and glycemic control in adults with T1DM (n=16-23 T1DM adults). The validation of the study developed Australian diabetes specific quality of life questionnaire and change in HbA1c and QoL in adults with T1DM while undertaking a low carbohydrate diet over 12 weeks will be the primary outcomes of this study. RESULTS No results are currently available. CONCLUSIONS This study is the first of its kind and will firstly generate a new validated instrument, which could be used in evidence-based practice and research to understand T1DM adults QoL. Secondly, the low carbohydrate dietary intervention outcomes could be used to inform clinicians about an alternative approach to assist T1DM Australian adults to improve their QoL and glycemic control. Finally, this study could warrant the development of an evidence based low carbohydrate dietary guideline for adults living with T1DM with the potential to have a profound impact on this population. CLINICALTRIAL ClinicalTrials.gov NCT04213300; https://www.clinicaltrials.gov/ct2/show/NCT04213300