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Background: The National Health Service spends £170 million on blood glucose monitoring (BGM) strips each year and there are pressures to use cheaper less accurate strips. Technology is also being used to increase test frequency with less focus on accuracy.Previous modeling/real-world data analysis highlighted that actual blood glucose variability can be more than twice blood glucose meter reported variability (BGMV). We applied those results to the Parkes error grid to highlight potential clinical impact., Method: BGMV is defined as the percent of deviation from reference that contains 95% of results. Four categories were modeled: laboratory (<5%), high accuracy strips (<10%), ISO 2013 (<15%), and ISO 2003 (<20%) (includes some strips still used).The Parkes error grid model with its associated category of risk including "alter clinical decision" and "affect clinical outcomes" was used, with the profile of frequency of expected results fitted into each BGM accuracy category., Results: Applying to single readings, almost all strip accuracy ranges derived in a controlled setting fell within the category: clinically accurate/no effect on outcomes areas.However modeling the possible blood glucose distribution in more detail, 30.6% of longer term results of the strips with current ISO accuracy would fall into the "alter clinical action" category. For previous ISO strips, this rose to 44.1%, and for the latest higher accuracy strips, this fell to 12.8%., Conclusion: There is a minimum standard of accuracy needed to ensure that clinical outcomes are not put at risk. This study highlights the potential for amplification of imprecision with less accurate BGM strips.

Aims: To compare the efficacy and safety of basal insulin peglispro (BIL), which has a flat pharmacokinetic and pharmacodynamic profile and a long duration of action, with insulin glargine (GL) in patients with type 1 diabetes., Materials and Methods: In this phase III, 52-week, blinded study, we randomized 1114 adults with type 1 diabetes in a 3 : 2 distribution to receive either BIL (n = 664) or GL (n = 450) at bedtime, with preprandial insulin lispro, using intensive insulin management. The primary objective was to compare glycated haemoglobin (HbA1c) in the groups at 52 weeks, with a non-inferiority margin of 0.4%., Results: At 52 weeks, mean (standard error) HbA1c was 7.38 (0.03)% with BIL and 7.61 (0.04)% with GL {difference -0.22% [95% confidence interval (CI) -0.32, -0.12]; p < 0.001}. At 52 weeks more BIL-treated patients reached HbA1c <7% (35% vs 26%; p < 0.001), the nocturnal hypoglycaemia rate was 47% lower (p < 0.001) and the total hypoglycaemia rate was 11% higher (p = 0.002) than in GL-treated patients, and there was no difference in severe hypoglycaemia rate. Patients receiving BIL lost weight, while those receiving GL gained weight [difference -1.8 kg (95% CI -2.3, -1.3); p < 0.001]. Treatment with BIL compared with GL at 52 weeks was associated with greater increases from baseline in levels of serum triglyceride [difference 0.19 mmol/l (95% CI 0.11, 0.26); p < 0.001] and alanine aminotransferase (ALT) levels [difference 6.5 IU/l (95% CI 4.1, 8.9), p < 0.001], and more frequent injection site reactions., Conclusions: In patients with type 1 diabetes, treatment with BIL compared with GL for 52 weeks resulted in a lower HbA1c, more patients with HbA1c levels <7%, and reduced nocturnal hypoglycaemia, but more total hypoglycaemia and injection site reactions and higher triglyceride and ALT levels., (© 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Aims: To determine the magnitude of the peripheral glucose gradient in patients with Type 1 diabetes in a real world setting and to explore its relationship with insulin dose and macronutrient intake., Methods: All patients used mealtime analogue insulin. The glucose gradient was assessed using antecubital fossa venous and finger-stick capillary samples, collected concurrently at room temperature. Baseline sampling occurred before the administration of an insulin dose and breakfast of the patient's choosing. Breakfast was consumed an average of 15 min after baseline. The macronutrient content of breakfast was documented. Sampling was repeated 1 and 2 h after baseline., Results: The mean (95% CI) plasma capillary-venous glucose gradient values for 43 patients were: pre-breakfast, 0.21 (0.08-0.34) mmol/l; 1 h after baseline, 0.87 (0.66-1.07) mmol/l; and 2 h after baseline, 0.52 (0.33-0.71) mmol/l. Glucose gradient and dietary carbohydrate intake (g/kg body weight) were positively correlated at both 1 h (P < 0.01) and 2 h after baseline (P < 0.01). No relationship was observed between this gradient and mealtime insulin dose, or the glucose concentration at either time point., Conclusions: In patients with Type 1 diabetes, a clinically significant glucose gradient is present after the ingestion of a carbohydrate-rich meal. As postprandial capillary and venous plasma glucose concentrations are not equivalent, defining the site of sample collection is important., (© 2015 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.)

Aims: Assessment of the long-term safety and efficacy of liquid inhaled insulin via AERx insulin Diabetes Management System (iDMS) in a basal/bolus treatment regimen of adults with Type 1 diabetes., Methods: Patients were randomized 2 : 1 to prandial inhaled (n = 205) or subcutaneous (s.c.) (n = 99) insulin, plus one/two daily injections of neutral protamine Hagedorn (NPH) insulin for 12 months. The primary endpoints were pulmonary function tests (PFT) and baseline changes in chest X-rays at 12 months. Safety and efficacy assessments were measured at regular intervals., Results: PFTs after 12 months were comparable between the groups, except for reduced per cent of predicted carbon monoxide lung diffusing capacity with inhaled insulin (difference: -2.03%, P = 0.04) occurring after the first 3 months and then stabilizing. There were no apparent treatment differences in chest X-rays. Overall risk of hypoglycaemia [risk ratio (RR) 1.02, P = 0.83] and adverse events were comparable between groups. Risk of nocturnal hypoglycaemia was higher in the inhaled group (RR 1.58, P = 0.001). Cough [10% (inhaled); 3% (s.c.)] tended to be mild in nature. Inhaled insulin was non-inferior to s.c. insulin for change in glycated haemoglobin (HbA(1c)) after 12 months [difference 0.18% (CI 95%-0.04; 0.39)]. At trial end, mean laboratory measured fasting plasma glucose was lower in the inhaled group (inhaled 9.2 mmol/l; s.c. 11.7 mmol/l; difference: -2.53 mmol/l, P < 0.001)., Conclusions: The safety and efficacy results in this trial were similar to those reported with other inhaled insulins; however, inhaled insulin using AERx iDMS requires further optimization to reduce nocturnal hypoglycaemia before it has comparable safety and efficacy to s.c. insulin aspart.

Aims: The incidence and prevalence of Type 1 diabetes is increasing internationally. There is, however, no current estimate of the prevalence of Type 1 diabetes in young New Zealanders. We therefore aimed to estimate prevalence in 0 to 24 year olds., Methods: The point prevalence of Type 1 diabetes was determined in a geographically defined area, namely the Canterbury District Health Board catchment area, by comparing data from multiple clinical and research sources. The New Zealand prevalence, stratified by age and ethnicity, was then estimated using 2001 population census data., Results: There were 353 people with diabetes aged 24 years and less, residing within the catchment area at the time of study. Of these 353 people, 330 had Type 1 diabetes, giving a prevalence of 227 per 100,000 children and young adults. The estimated number of New Zealanders with Type 1 diabetes in this defined age group, adjusted for ethnicity, was 2,540. An estimated 2,158 were of European descent., Conclusions: Although the prevalence of Type 1 diabetes is lower in non European New Zealanders compared to European New Zealanders, the changing demographics of children and youth in New Zealand means that there are increasing numbers of Maori, Asian, and Pacific peoples with Type 1 diabetes.

This study examined the epidemiological characteristics of type 1 diabetes mellitus (DM) presenting in Canterbury, New Zealand, between 1970 and 1999. All patients with type 1 DM aged 0-19 years at diagnosis within the Canterbury geographical region were either admitted to the regional hospital or seen acutely as outpatients in clinics at the same institution. Primary ascertainment of incident cases, through notification by the attending physician or paediatrician, began prospectively in 1982. Incident cases between 1970 and 1982 were ascertained retrospectively from clinic and hospital records. For the years 1970-99, there were 474 incident cases (256 males, 218 females). Incidence rates determined from 5-yearly census population denominators ranged from 2.40 to 26.59 patients/100,000 person years. The mean for 5-year periods, starting from 1970, increased from 6.79 to 22.79 patients/100,000 person years, i.e. a 3.4-fold increase over 30 years. The increase in incidence based on linear regression of these data is 0.59 patients/100,000 per year, or an annual increase of 5% derived from regression of the natural logarithms of the incidence data. These observations are consistent with the increasing attack rates for type 1 DM reported worldwide.

While the ethnic make up of the New Zealand population is predominantly European, the Polynesian population, consisting of indigenous New Zealand Maori and more recent immigrants from the other Pacific Islands is increasing rapidly. The prevalence of diabetes in these Polynesians is high. There is also an increasing prevalence of obesity, and obesity is a greater problem amongst Polynesian people. The number of elderly people in the population is increasing. All of these demographic changes are increasing the incidence and prevalence of Type 2 diabetes. The incidence of Type 1 diabetes is also rising, although the reasons for this are unknown. Diabetic nephropathy is the most common cause of end stage renal failure in New Zealand. Polynesian people with diabetes, and in particular Maori, have a very high rate of diabetic nephropathy and develop renal failure at a more rapid rate than European patients with nephropathy relating to Type 1 diabetes. The propensity for Maori patients with Type 2 diabetes to develop renal failure may relate to a younger age at the onset of diabetes, a genetic susceptibility to nephropathy, and socio-economic or cultural factors leading to less adequate medical care.

In an ambulatory population of diabetic subjects (Type 1 and Type 2), the urine excretion of the renal osmolyte, glycine betaine, was compared to known markers of glycemic control, renal dysfunction and to the excretion of related betaines, including trigonelline, proline betaine, carnitine and acetyl-carnitine. Of the 85 subjects, 20 patients had urine glycine betaine concentrations above the reference range for normal subjects. Plasma glycine betaine concentrations were within reference ranges for normal subjects. Patients with elevated glycine betaine excretion tended to have lower plasma glycine betaine concentrations, but this did not reach statistical significance. One way analysis of variance found excretion is independent of treatment, duration of diagnosed diabetes, blood pressure and body mass index (BMI). An association between glycine betaine excretion and glycemic control was observed with statistically significant correlations occurring with both plasma glucose (r = 0.43, P < 0.001) and glycated haemoglobin (HbA1c) (r = 0.35, P < 0.005). The excretion of carnitine, acetyl-carnitine and proline betaine were related to glycine betaine excretion (r = 0.49, P < 0.001; r = 0.40, P < 0.001; r = 0.27, P < 0.05, respectively). Urine carnitine and acetyl-carnitine concentrations were also related to plasma glucose concentrations (r = 0.30, P < 0.01). Increased urine retinol binding protein concentrations (RBP), a marker of proximal tubular dysfunction, correlated with elevated urine glycine betaine excretion and plasma HbA1c (r = 0.28, P < 0.01). These results suggest poor glycemic control is associated with the increase in urine glycine betaine, carnitine, acetyl-carnitine and RBP excretion in diabetic patients. However, < 50% of the observed increase in glycine betaine excretion has been accounted for by the variables measured, suggesting other unidentified processes may also be involved.

This study aimed to explore multiple determinants of BMD (bone mineral density) in 99 women with long-standing type 1 diabetes, recruited from a population based register of insulin users. BMD was measured using DEXA (dual energy X-ray absorptiometry) at the femoral neck and lumbar spine, age adjusted Z scores were calculated and results compared to those of healthy volunteers. The median age of diabetic subjects was 42 years and the median duration of diabetes was 27 years. BMD was positively associated with body mass index and height at both the lumbar spine and femoral neck. There was a positive association with oral contraceptive pill use and lumbar spine BMD, and peripheral vascular disease was negatively associated with femoral neck BMD. No correlation was seen with either age or duration of diabetes and absolute BMD values. Mean Z score at the femoral neck was -0.12 (95% confidence interval -0.37 to +0.12). At the lumbar spine, the corresponding value was -0.21 (-0.44 to +0.02). Pre- and post-menopausal values for the diabetic subjects and healthy volunteers were found to be similar. In summary, axial BMD values in subjects with long-standing diabetes were similar to those observed in healthy non diabetic populations.

Perimenstrual changes in glycaemic control and insulin requirements have been reported in Type 1 diabetes. A population-based sample of 124 women with Type 1 diabetes, aged 18 to 40 years, were questioned regarding perimenstrual changes in their self-monitored capillary blood glucose and insulin regimen. Sixty-one percent of women noted perimenstrual changes in capillary blood glucose. The commonest pattern was a premenstrual rise in glucose. Thirty-six percent of all study participants were making adjustments to their insulin dose in response to these changes in capillary blood glucose. There was no statistical difference in the mean glycated haemoglobin of subjects making perimenstrual adjustments in insulin (79.1 mmol mol-1 haem) compared to subjects who noted cyclical capillary glucose changes but did not adjust insulin (73.0 mmol mol-1 haem). Sixty-seven percent of subjects taking the fixed dose oestrogen/progesterone oral contraceptive pill (OCP) noted perimenstrual changes in glucose. In summary, a third of the women surveyed made perimenstrual adjustments to their insulin dose, but there was no evidence to suggest that this behaviour was associated with improved glycaemic control. Use of the fixed dose combined oral contraceptive pill did not eliminate perimenstrual changes in glucose.

Aims: To assess the incidence of vaginal symptoms in younger women with insulin dependent diabetes, and also to assess the relationship between symptoms and other clinical risk factors for candidiasis., Method: A population-based questionnaire was administered to women aged 18-40 years with insulin dependent diabetes. Subjects were asked about symptoms of "vaginal thrush" as a surrogate question for symptoms suggestive of vaginal infection. Glycaemic control was assessed by measurement of glycated haemoglobin. (Non-diabetic reference range of 30-50 mmol/mol haem)., Results: One hundred and twenty-four out of 144 eligible women completed the questionnaire, a participation rate of 86%. Of the women interviewed, 60% had experienced one or more episodes attributed to "vaginal thrush", in the previous year. All seven subjects with a glycated haemoglobin of 100 mmol/mol haem or greater, experienced vaginal symptoms in the previous year. The relationship between frequency of vaginal symptoms and glycated haemoglobin was however weak., Conclusions: Vaginal symptoms are common in younger women with insulin dependent diabetes and are not confined to subjects with poor diabetes control. We recommend that health professionals caring for these women enquire about symptoms of vaginitis so that appropriate diagnosis and treatment can be initiated.

Aims: To assess knowledge and attitudes of women with insulin dependent diabetes to contraception, prepregnancy planning, and genetic risk., Method: Women with insulin dependent diabetes, aged 18 to 40, were identified from a population-based register of insulin users in North Canterbury. Participating subjects underwent a structured face to face interview, assessing current contraceptive practices and their knowledge and attitudes to the areas outlined above., Results: One hundred and twenty four women, representing 86% of eligible women, agreed to participate. Eighty five subjects were using some form of contraception. The most popular choices were the combined oral contraceptive pill (35%), the progesterone only pill (12%), condoms (24%), vasectomy (12%) and tubal ligation (12%). All subjects recognised the importance of good blood glucose control during pregnancy. Thirty nine percent of subjects using contraception avoided the combined oral contraceptive pill because of concerns about metabolic and vascular side effects. Only 52% of subjects knew the correct figure for genetic risk of passing insulin dependent diabetes on to an offspring., Conclusions: Patient education regarding the need for prepregnancy planning in women with insulin dependent diabetes appeared adequate and the percentage of subjects using contraception was higher than that described in overseas diabetic populations. Over a third of subjects were however concerned about the risks of contraceptive options in insulin dependent diabetes, particularly with regard to the use of the combined oral contraceptive pill. This finding suggests that discussion about the advantages and disadvantages of contraceptive choices should be an integral part of patient education for women with insulin dependent diabetes mellitus of child-bearing age. Knowledge about genetic risk was inadequate in half the subjects interviewed, and this area of patient education could also be improved.

Aims: 1. To determine the prevalence of insulin self manipulation for the purposes of weight control, in a population based study of young women with insulin dependent diabetes. 2. To compare the North Canterbury prevalence of insulin self manipulation with figures reported in overseas studies., Method: All women with insulin dependent diabetes aged 18 to 30 years inclusive and resident in North Canterbury, were invited to an interview to document their diabetes self-care behaviour. A blood sample was taken at the time of interview for measurement of glycated haemoglobin., Results: Ninety three percent of eligible women agreed to participate in the study. Twelve of the 69 participating women (17%) admitted to reducing their insulin dose at some time in the past, for the purposes of weight loss. This figure is significantly lower than the 37% (p = 0.047), reported from a British study, and the figure of 39% (p = 0.006), reported from the United States. The median glycated haemoglobin of the twelve subjects who reported manipulating their insulin was slightly higher than that of the remaining 57 subjects, but this difference did not reach statistical significance (79 mmol/mol haem versus 71 mmol/mol haem, p = 0.07)., Conclusions: The self reported prevalence of insulin manipulation for the purposes of weight loss appears to be lower in North Canterbury, compared to overseas studies. The reason for this difference is unexplained. Health care professionals should nevertheless be aware of this method of weight reduction, as it has been associated with poor diabetes control, clinical eating disorders and possible long term detrimental effects on health.

Previous reviews of diabetic subjects using insulin for 50 years or more have been based on clinic populations or on individuals receiving medals to mark this achievement. We interviewed all 11 subjects who had been on insulin for 50 years or more, identified from a population-based register of insulin users in North Canterbury, New Zealand. Seven of the 11 subjects had required treatment for micro- or macrovascular disease, but the functional level of the majority of survivors was nevertheless high. Diabetes had a major social impact on only one of the subjects interviewed.