The effect of additional mealtime insulin bolus using an insulin-to-protein ratio compared to usual carbohydrate counting on postprandial glucose in those with type 1 diabetes who usually follow a carbohydrate-restricted diet: A randomized cross-over trial.

This randomized controlled cross-over study compared postprandial glucose concentrations and incidence of hypoglycaemia for mealtime bolus insulin calculated for both meal protein and carbohydrate content, with ordinary dosing for carbohydrate content alone, in adults with type 1 diabetes who usually follow a carbohydrate-restricted diet. All 16 participants completed three test meals under each of the two conditions. The primary outcome was the time normalized Area Under the Curve (AUC) of glucose measurements. The mean (SD) AUC glucose concentration for insulin dosing for both protein and carbohydrate was 8.3 (2.1) mmol/L compared with 10.0 (2.2) mmol/L for carbohydrate alone. The difference (95% CI) was -1.76 mmol/L (-2.87 to -0.65), P = .003. The mean (SD) glucose concentration ≥ 8.0 mmol/L was 54.8 (32.4)% for dosing for protein and carbohydrate and 73.7 (26.3)% for carbohydrate alone, rate ratio (95% CI) 0.75 (0.62 to 0.89), P = .002. For glucose concentration < 4.0 mmol/L 5.5 (15.1)% and 2.8 (11.7)%; rate ratio (95% CI): 1.97 (0.90 to 4.27), P = .087. Calculating the meal insulin requirements based on the carbohydrate and protein content may have advantages over calculations based on carbohydrate alone. Further studies are required to determine how to best optimize this.

A randomised trial of the feasibility of a low carbohydrate diet vs standard carbohydrate counting in adults with type 1 diabetes taking body weight into account.

BACKGROUND AND OBJECTIVES: To determine the effect of a low carbohydrate diet and standard carbohydrate counting on glycaemic control, glucose excursions and daily insulin use compared with standard carbohydrate counting in participants with type 1 diabetes. METHODS AND STUDY DESIGN: Participants (n=10) with type 1 diabetes using a basal; bolus insulin regimen, who attended a secondary care clinic, were randomly allocated (1:1) to either a standard carbohydrate counting course or the same course with added information on following a carbohydrate restricted diet (75 g per day). Participants attended visits at baseline and 12 weeks for measurements of weight, height, blood pressure, HbA1c, lipid profile and creatinine. They also completed a 3-day food diary and had 3 days of continuous subcutaneous glucose monitoring. RESULTS: The carbohydrate restricted group had significant reductions in HbA1c (63 to 55 mmol/mol (8.9-8.2%), p<0.05) and daily insulin use (64.4 to 44.2 units/day, p<0.05) and non-significant reductions in body weight (83.2 to 78.0 kg). There were no changes in blood pressure, creatinine or lipid profile and all outcomes in the carbohydrate counting group were unchanged. There was no change in glycaemic variability as measured by the mean amplitude of glycaemic excursion in either group. CONCLUSIONS: A low carbohydrate diet is a feasible option for people with type 1 diabetes, and may be of benefit in reducing insulin doses and improving glycaemic control, particularly for those wishing to lose weight.

From 'pleasure to chemistry': the experience of carbohydrate counting with and without carbohydrate restriction for people with Type 1 diabetes.

INTRODUCTION: Matching carbohydrate intake with insulin dosage is recommended management for people with Type 1 diabetes. However, international interest in restricted carbohydrate diets is growing. General practitioners and practice nurses need to know how to advise people with Type 1 diabetes regarding low-carbohydrate diets. This study aimed to explore the carbohydrate counting experiences of people with Type 1 diabetes in a trial with and without a diet restricted to 75 g of carbohydrate per day. METHODS: Eight participants were interviewed by focus group or interview 12 weeks after a carbohydrate counting course with individual dietary choice or the same course with information on restricted carbohydrate eating and a daily maximum intake of 75 g of carbohydrate. Data were analysed using a qualitative thematic analysis approach. FINDINGS: Themes included the need for insulin management skills, impact of the dietary experience, and need for dietary knowledge. The restricted-carbohydrate group encountered mealtime insulin resistance and difficulty managing insulin dosages when transitioning on and off the low-carbohydrate diet. The diet impacted on mood, feelings of satiety and it was reported that food changed from being 'a pleasure to chemistry'. Both groups described feeling empowered to manage their diabetes as a result of the carbohydrate counting course. CONCLUSION: Participants reported increased knowledge and challenging insulin management. The restricted-carbohydrate group reported mealtime insulin resistance and a strong dietary impact. Extra health professional support may be required, especially at dietary transition periods. More research is warranted into the reported mealtime insulin resistance.

The informed consent process in randomised controlled trials: a nurse-led process.

Clinical trials are carried out with human participants to answer questions about the best way to diagnose, treat and prevent illness. Participants must give informed consent to take part in clinical trials that requires understanding of how clinical trials work and their purpose. Randomised controlled trials provide strong evidence but their complex design is difficult for both clinicians and participants to understand. Increasingly, ensuring informed consent in randomised controlled trials has become part of the clinical research nurse role. The aim of this study was to explore in depth the clinical research nurse role in the informed consent process using a qualitative descriptive approach. Three clinical research nurses were interviewed and data analysed using a thematic analysis approach. Three themes were identified to describe the process of ensuring informed consent. The first theme, Preparatory partnerships, canvassed the relationships required prior to initiation of the informed consent process. The second theme, Partnering the participant, emphasises the need for ensuring voluntariness and understanding, along with patient advocacy. The third theme, Partnership with the project, highlights the clinical research nurse contribution to the capacity of the trial to answer the research question through appropriate recruiting and follow up of participants. Gaining informed consent in randomised controlled trials was complex and required multiple partnerships. A wide variety of skills was used to protect the safety of trial participants and promote quality research. The information from this study contributes to a greater understanding of the clinical research nurse role, and suggests the informed consent process in trials can be a nurse-led one. In order to gain collegial, employer and industry recognition it is important this aspect of the nursing role is acknowledged.