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COPYRIGHT AND USE OF THIS THESIS This thesis must be used in accordance with the provisions of the Copyright Act 1968. Reproduction of material protected by copyright may be an infringement of copyright and copyright owners may be entitled to take legal action against persons who infringe their copyright. Section 51 (2) of the Copyright Act permits an authorized officer of a university library or archives to provide a copy (by communication or otherwise) of an unpublished thesis kept in the library or archives, to a person who satisfies the authorized officer that he or she requires the reproduction for the purposes of research or study. The Copyright Act grants the creator of a work a number of moral rights, specifically the right of attribution, the right against false attribution and the right of integrity. You may infringe the author’s moral rights if you: - fail to acknowledge the author of this thesis if you quote sections from the work - attribute this thesis to another author - subject this thesis to derogatory treatment which may prejudice the author’s reputation For further information contact the University’s Director of Copyright Services sydney.edu.au/copyright APPENDIX Clinical Application of the Food Insulin Index to Diabetes Mellitus Kirstine Bell B.Nutr&Diet (Hons), GradCertDiabEd (Dist) Submitted in total fulfillment of the requirements of the degree of Doctor of Philosophy 5 September 2014 Appendix Table of Contents Section 1: Carbohydrate Counting Systematic Review and Meta-Analysis Appendix 1: Published journal article Appendix 2: Search strategy Section 2: FII Testing Appendix 3: FII database (121 foods) Appendix 4: Participant information sheet Appendix 5: Consent form Appendix 6: Screening questionnaire Appendix 7: Test session questionnaire Section 3: FII for Protein Foods Study (NIDDA 2) Appendix 8: Participant information sheet Appendix 9: Consent form Appendix 10: Study advertisement Appendix 11: Screening questionnaire Appendix 12: Test session questionnaire ii Appendix Section 4: FOODII Study Appendix 13: Participant information sheet Appendix 14: Consent form Appendix 15: Study Advertisement Appendix 16: Screening questionnaire Appendix 17: Study completion questionnaire Appendix 18: Group education workshop teaching plans Section 5: FII in Type 2 Diabetes Study Appendix 19: Participant information sheet Appendix 20: Consent form Appendix 21: Screening questionnaire Appendix 22: Study completion questionnaire iii Appendix 1 Published Journal Article “The efficacy of carbohydrate counting in type 1 diabetes: a systematic review & meta-analysis” ! ! ! ! ! ! ! Articles Effi cacy of carbohydrate counting in type 1 diabetes: a systematic review and meta-analysis Kirstine J Bell, Alan W Barclay, Peter Petocz, Stephen Colagiuri, Jennie C Brand-Miller Summary Background Although carbohydrate counting is the recommended dietary strategy for achieving glycaemic control in Published Online people with type 1 diabetes, the advice is based on narrative review and grading of the available evidence. We aimed to October 25, 2013 assess by systematic review and meta-analysis the effi cacy of carbohydrate counting on glycaemic control in adults http://dx.doi.org/10.1016/ S2213-8587(13)70144-X and children with type 1 diabetes. See Online/Comment http://dx.doi.org/10.1016/ Methods We screened and assessed randomised controlled trials of interventions longer than 3 months that compared S2213-8587(13)70159-1 carbohydrate counting with general or alternate dietary advice in adults and children with type 1 diabetes. Change in Boden Institute of Obesity, Nutrition, Exercise and Eating glycated haemoglobin (HbA1c) concentration was the primary outcome. The results of clinically and statistically homogenous studies were pooled and meta-analysed using the random-eff ects model to provide estimates of the Disorders, and the School of Molecular Bioscience, effi cacy of carbohydrate counting. University of Sydney, Sydney, NSW, Australia Findings We identifi ed seven eligible trials, of 311 potentially relevant studies, comprising 599 adults and 104 children (K J Bell BNutrDiet, with type 1 diabetes. Study quality score averaged 7·6 out of 13. Overall there was no signifi cant improvement in A W Barclay PhD, S Colagiuri FRACP, HbA1c concentration with carbohydrate counting versus the control or usual care (–0·35% [–3·9 mmol/mol], Prof J C Brand-Miller PhD); 95% CI –0·75 to 0·06; p=0·096). We identifi ed signifi cant heterogeneity between studies, which was potentially Australian Diabetes Council, related to diff erences in study design. In the fi ve studies in adults with a parallel design, there was a 0·64% point Sydney, NSW, Australia (7·0 mmol/mol) reduction in HbA with carbohydrate counting versus control (95% CI –0·91 to –0·37; p<0·0001). (A W Barclay); and Department 1c of Statistics, Macquarie University, Sydney, NSW, Interpretation There is some evidence to support the recommendation of carbohydrate counting over alternate advice Australia (P Petocz PhD) or usual care in adults with type 1 diabetes. Additional studies are needed to support promotion of carbohydrate Correspondence to: counting over other methods of matching insulin dose to food intake. Prof Jennie Brand-Miller, School of Molecular Bioscience, Biochemistry Building, G08, Funding None. University of Sydney, Sydney, NSW, 2006, Australia Introduction to restore blood glucose levels using an artifi cial pancreas. jennie.brandmiller@sydney. Type 1 diabetes is an autoimmune disorder characterised Further work confi rmed the linear relation between edu.au by chronic hyperglycaemia, which results from an carbohydrate intake and insulin need.4 However, the absolute endogenous insulin defi ciency. Present medical underlying theoretical basis and its practical use have management revolves around exogenous insulin therapy since been questioned.5–9 Bao and colleagues,10 for to restore blood glucose levels to within an optimum example, showed that available carbohydrate range. At present there is no cure for type 1 diabetes; (ie, carbohydrates that are able to be digested and therefore, eff ective strategies to assist in the achievement absorbed) could explain much of the variance in glucose and maintenance of normoglycaemia are needed to response to isocaloric portions of single foods, but was promote the acute and long-term health and wellbeing of not a signifi cant predictor of the response to mixed meals individuals with type 1 diabetes. containing variable amounts of carbohydrate, fat, and Carbohydrate counting has long been thought of as the protein. Moreover, the same amount of available cornerstone of intensive insulin therapy, with bolus carbohydrate from diff erent food sources is known to insulin doses matched to the total carbohydrate content produce signifi cantly varying blood glucose responses in of the meal.1 This practice is based on the premise that both healthy individuals and those with diabetes.5,11,12 carbohydrate is the predominant macronutrient Indeed, the predictable diff erence in responses to contributing to the rise in postprandial glycaemia. diff erent carbohydrate-containing foods is the basis of Carbohydrate counting ranges from an awareness of the glycaemic index (GI). foods that contain carbohydrate and their eff ect on blood Surprisingly, the effi cacy of carbohydrate counting has glucose levels, through to counting the number of 15 g not been assessed as a benchmark for other dietary carbohydrate exchanges, 10 g portions, or grams of strategies. Present international recommendations1,8,13 carbohydrate eaten. An insulin to carbohydrate ratio is supporting the use of carbohydrate counting in practice used to calculate the bolus insulin dose needed.2 are based simply on narrative review and grading of the 30 years ago, Slama and colleagues3 showed a limited available evidence. Hence, our objective was to do signifi cant correlation between the amount of a systematic review and meta-analysis of randomised carbohydrate consumed and the dose of insulin needed controlled trials, comparing carbohydrate counting www.thelancet.com/diabetes-endocrinology Published online October 25, 2013 http://dx.doi.org/10.1016/S2213-8587(13)70144-X 1 Articles interventions with general or alternate dietary advice in by the reviewers for compliance with the selection criteria. adults and children with type 1 diabetes. Glycaemic To be included, studies had to be written in English and control, as judged by glycated haemoglobin (HbA1c) published between January, 1980, and August, 2013. All concentration, was the primary outcome measure. published randomised and quasirandomised controlled clinical trials of interventions that compared the Methods management of type 1 diabetes with and without Search strategy and selection criteria carbohydrate counting in either children or adults with We searched all relevant biomedical databases, including type 1 diabetes for at least 3 months were included. Trials Medline, Embase, the Cumulative Index to Nursing and in pregnant women were acceptable. For this analysis, Allied Health Literature, Web of Knowledge, and the carbohydrate counting was defi ned as all methods of Cochrane Central Register of Controlled Trials. In quantifying the amount of carbohydrate consumed for the consultation with a medical librarian, we developed a purpose of establishing prandial insulin dose, in search strategy based on an analysis of medical subject accordance with the defi nition of the American Diabetes headings, terms, and key text words from January, 1980,