Randomized Study to Evaluate the Impact of Telemedicine Care in Patients With Type 1 Diabetes With Multiple Doses of Insulin and Suboptimal HbA1c in Andalusia (Spain): PLATEDIAN Study.

OBJECTIVE: To assess the impact of a telemedicine visit using the platform Diabetic compared with a face-to-face visit on clinical outcomes, patients' health-related quality of life (HRQoL), and physicians' satisfaction in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS: PLATEDIAN (Telemedicine on Metabolic Control in Type 1 Diabetes Mellitus Andalusian Patients) (NCT03332472) was a multicenter, randomized, 6-month follow-up, open-label, parallel-group controlled study performed in patients with type 1 diabetes with suboptimal metabolic control (HbA1c <8% [<64 mmol/mol]), treated with multiple daily injections. A total of 388 patients were assessed for eligibility; 379 of them were randomized 1:1 to three face-to-face visits (control cohort [CC]) (n = 167) or the replacement of an intermediate face-to-face visit by a telemedicine visit using Diabetic (intervention cohort [IC]) (n = 163). The primary efficacy end point was the mean change of HbA1c levels from baseline to month 6. Other efficacy and safety end points were mean blood glucose, glucose variability, episodes of hypoglycemia and hyperglycemia, patient-reported outcomes, and physicians' satisfaction. RESULTS: At month 6, the mean change in HbA1c levels was -0.04 ± 0.5% (-0.5 ± 5.8 mmol/mol) in the CC and 0.01 ± 0.6% (0.1 ± 6.0 mmol/mol) in the IC (P = 0.4941). The number of patients who achieved HbA1c <7% (<53 mmol/mol) was 73 and 78 in the CC and IC, respectively. Significant differences were not found regarding safety end points at 6 months. Changes in HRQoL between the first visit and final visit did not differ between cohorts, and, regarding fear of hypoglycemia (FH-15 score ≥28), statistically significant differences observed at baseline remained unchanged at 6 months (P < 0.05). CONCLUSIONS: The use of telemedicine in patients with type 1 diabetes with HbA1c <8% (<64 mmol/mol) provides similar efficacy and safety outcomes as face-to-face visits.

Randomized clinical trial of the efficacy and safety of insulin glargine vs. NPH insulin as basal insulin for the treatment of glucocorticoid induced hyperglycemia using continuous glucose monitoring in hospitalized patients with type 2 diabetes and respiratory disease.

AIMS: To investigate the clinical efficacy and safety of insulin glargine compared with NPH insulin as basal insulin for the management of corticosteroid-induced hyperglycemia in hospitalized people with type 2 diabetes (T2DM) and respiratory disease. MATERIALS AND METHODS: Randomized, two-arm parallel group, clinical trial undertaken from February 2011 to November 2012 on the pneumology ward of the Hospital Regional Universitario de Málaga (Spain), involving 53 participants with T2DM treated with medium/high doses of intermediate-acting corticosteroids. Participants were randomly assigned to receive one single dose of insulin glargine or NPH insulin in three equally divided doses before each meal as basal insulin within a basal-bolus insulin protocol. The intervention lasted six days or until discharge if earlier. RESULTS: No significant differences were seen between groups during the study in mean blood glucose (11.43±3.44 mmol/l in glargine vs. 11.88±2.94 mmol/l in NPH, p=0.624), and measures of glucose variability (standard deviation 3.27±1.16 mmol/l vs. 3.61±0.99 mmol/l, p=0.273; coefficient of variation 1.55±0.33 mmol/l vs. 1.72±0.39 mmol/l, p=0.200). Results from CGM were concordant with those obtained with capillary blood glucose reading. The length of hospital stay was also similar between groups (8.2±2.8 days vs. 9.8±3.4 days, p=0.166) There was a non significant trend for lower episodes of mild (4 vs. 8, p=0.351) and severe hypoglycemia (0 vs. 3, p=0.13) in the glargine group. CONCLUSIONS: The results of this study showed that insulin glargine and NPH insulin are equally effective in a basal-bolus insulin protocol to treat glucocorticoid-induced hyperglycemia in people with T2DM on a pneumology ward.

Evolution of urinary iodine excretion over eleven years in an adult population.

BACKGROUND & AIMS: Few prospective cohort studies have evaluated dietary iodine intake and urinary iodine concentrations in the general adult population. We assess the evolution of urinary iodine excretion and factors that may influence it in an adult population followed for 11 years. METHODS: A population-based cohort study was undertaken in Pizarra (Spain). In the three study phases (baseline (n = 886), and 6 (n = 788) and 11 years later (n = 501)), participants underwent an interview and a standardized clinical examination that included a food questionnaire, and thyroid hormone and urinary iodine determinations. Subjects with thyroid dysfunction, palpable goiter or urinary iodine excretion >400 µg/L were excluded. RESULTS: Urinary iodine increased over the years (100.6 ± 70.0 µg/L at baseline vs. 125.4 ± 95.2 µg/L at 6 years and 141.6 ± 81.4 µg/L at 11 years; p < 0.0001). Urinary iodine was significantly higher in subjects who reported iodized salt consumption and in subjects with a higher intake of dairy products (p < 0.05). Consumption of iodized salt (Risk ratio (RR) = 1.23, 95% CI [1.01-2.05]) and dairy products (RR = 2.07, 95% CI [1.01-4.23]), and a baseline urinary iodine concentration ≥100 µg/L (RR = 1.26, 95% CI [1.04-1.53]) were significantly associated with urinary iodine concentrations ≥100 µg/L at 11 years. There is no correlation between thyroid function (TSH, free triiodothyronine or free thyroxine levels) and urinary iodine concentrations in conditions of iodine sufficiency. CONCLUSIONS: The increase in urinary iodine concentrations over eleven years is associated with an increase in iodized salt intake and with the dairy products intake, and possibly with a higher iodine content of dairy products. However, individual variability in urinary iodine excretion was not fully explained by dietary iodine intake alone; previous urinary iodine concentrations were also important.

Stress hyperglycaemia in hospitalized patients with coronary artery disease and type 2 diabetes risk.

AIMS: (i) To evaluate glucometabolic status of patients without known diabetes hospitalized due to coronary artery disease (CAD), (ii) to assess markers of systemic inflammation determined during admission and to evaluate their relationship with glucometabolic status and (iii) to analyse usefulness of HbA1c determined during admission in patients with CAD to detect abnormal glucose regulation (AGR). MATERIALS & METHODS: We studied 440 patients with CAD admitted to the cardiology ward. Patients were grouped in four groups during admission according to clinical data, fasting plasma glucose and HbA1c: diabetes, HbA1c > 5·9%, stress hyperglycaemia (SH) and normal. In 199 subjects without known diabetes, an oral glucose tolerance test (OGTT) was performed 3 months after discharge, and they were reclassified according to WHO 1998 criteria. Biochemical and inflammatory markers were measured. RESULTS: The OGTT showed that 27·4% of subjects without known diabetes at admission had diabetes, 11·2% had impaired fasting glucose + impaired glucose tolerance, 33·5% impaired glucose tolerance, 3·6% impaired fasting glucose, and 24·4% normal glucose metabolism. Odds ratio for having diabetes 3 months after discharge in HbA1c > 5·9% group was 5·91 (P < 0·0001) and in SH group was 1·82 (P = 0·38). The best HbA1c cut-off point to predict AGR was 5·85%. HbA1c levels during admission were highly predictive of having AGR (AUC ROC 0·76 [95% CI 0·67-0·84]). CONCLUSION: We reported a high prevalence of AGR in subjects with CAD. Stress hyperglycaemia in patients with CAD was not associated with an increased risk of diabetes 3 months later. HbA1c in patients hospitalized with CAD was a useful tool to detect AGR.