Practical implementation of automated closed-loop insulin delivery: A French position statement.

Automated closed-loop (CL) insulin therapy has come of age. This major technological advance is expected to significantly improve the quality of care for adults, adolescents and children with type 1 diabetes. To improve access to this innovation for both patients and healthcare professionals (HCPs), and to promote adherence to its requirements in terms of safety, regulations, ethics and practice, the French Diabetes Society (SFD) brought together a French Working Group of experts to discuss the current practical consensus. The result is the present statement describing the indications for CL therapy with emphasis on the idea that treatment expectations must be clearly defined in advance. Specifications for expert care centres in charge of initiating the treatment were also proposed. Great importance was also attached to the crucial place of high-quality training for patients and healthcare professionals. Long-term follow-up should collect not only metabolic and clinical results, but also indicators related to psychosocial and human factors. Overall, this national consensus statement aims to promote the introduction of marketed CL devices into standard clinical practice.

Practical implementation, education and interpretation guidelines for continuous glucose monitoring: A French position statement.

The use by diabetes patients of real-time continuous interstitial glucose monitoring (CGM) or the FreeStyle Libre® (FSL) flash glucose monitoring (FGM) system is becoming widespread and has changed diabetic practice. The working group bringing together a number of French experts has proposed the present practical consensus. Training of professionals and patient education are crucial for the success of CGM. Also, institutional recommendations must pay particular attention to the indications for and reimbursement of CGM devices in populations at risk of hypoglycaemia. The rules of good practice for CGM are the precursors of those that need to be enacted, given the oncoming emergence of artificial pancreas devices. It is necessary to have software combining user-friendliness, multiplatform usage and average glucose profile (AGP) presentation, while integrating glucose and insulin data as well as events. Expression of CGM data must strive for standardization that facilitates patient phenotyping and their follow-up, while integrating indicators of variability. The introduction of CGM involves a transformation of treatment support, rendering it longer and more complex as it also includes specific educational and technical dimensions. This complexity must be taken into account in discussions of organization of diabetes care.

Indication, organization, practical implementation and interpretation guidelines for retrospective CGM recording: A French position statement.

AIM: The benefits of retrospective continuous glucose monitoring (retroCGM) recording have been widely explored in clinical studies, and many diabetes physicians routinely use this examination. However, the method of interpretation of CGM recordings has never been precisely described. METHOD: An expert French panel of physicians met for two days to discuss several aspects of retroCGM use and to produce a position statement. RESULTS: The guidelines cover the indications for retroCGM, the general organization and practical implementation of CGM recordings, a description of the different devices available and guidelines for the interpretation of retroCGM recordings. CONCLUSION: This consensus document should help clinicians in the proper use of retroCGM.

Insulin-based strategies to prevent hypoglycaemia during and after exercise in adult patients with type 1 diabetes on pump therapy: the DIABRASPORT randomized study.

AIMS: To validate strategies to prevent exercise-induced hypoglycaemia via insulin-dose adjustment in adult patients with type 1 diabetes (T1D) on pump therapy. METHODS: A total of 20 patients randomly performed four 30-min late post-lunch (3 h after lunch) exercise sessions and a rest session: two moderate sessions [50% maximum oxygen consumption (VO2 max)] with 50 or 80% basal rate (BR) reduction during exercise + 2 h and two intense sessions (75% VO2 max) with 80% BR reduction or with their pump stopped. Two additional early post-lunch sessions (90 min after lunch) were analysed to compare hypoglycaemia incidence for BR reduction versus bolus reduction. RESULTS: In all, 100 late post-lunch sessions were analysed. Regardless of exercise type and BR reduction, no more hypoglycaemic events occurred in the period until the next morning than occurred after the rest sessions. In the afternoon, no more hypoglycaemic events occurred with 80% BR reduction/moderate exercise or with pump discontinuation/intense exercise than for the rest session, whereas more hypoglycaemic events occurred with 50% BR reduction/moderate exercise and 80% BR reduction/intense exercise. After early post-lunch exercise (n = 37), a trend towards fewer hypoglycaemic episodes was observed with bolus reduction versus BR reduction (p = 0.07). Mean blood glucose fell by ∼3.3 mmol/l after 30 min of exercise, irrespective of dose reduction, remaining stable until the next morning with no rebound hyperglycaemia. CONCLUSION: In adults with T1D, to limit the hypoglycaemic risk associated with 30 min of exercise 3 h after lunch, without carbohydrate supplements, the best options seem to be to reduce BR by 80% or to stop the pump for moderate or intense exercise, or for moderate exercise 90 min after lunch, to reduce the prandial bolus rather than the BR.

Autoimmune disorders and quadrivalent human papillomavirus vaccination of young female subjects.

OBJECTIVES: The aim of this study was to investigate whether the quadrivalent human papillomavirus (HPV) vaccine Gardasil is associated with a change in the risk of autoimmune disorders (ADs) in young female subjects. DESIGN: Systematic case-control study of incident ADs associated with quadrivalent HPV vaccination in young women across France. PARTICIPANTS AND SETTING: A total of 113 specialised centres recruited (from December 2007 to April 2011) females aged 14-26 years with incident cases of six types of ADs: idiopathic thrombocytopenic purpura (ITP), central demyelination/multiple sclerosis (MS), Guillain-Barré syndrome, connective tissue disorders (systemic lupus erythematosus, rheumatoid arthritis/juvenile arthritis), type 1 diabetes mellitus and autoimmune thyroiditis. Control subjects matched to cases were recruited from general practice. ANALYSIS: Multivariate conditional logistic regression analysis; factors included age, geographical origin, smoking, alcohol consumption, use of oral contraceptive(s) or vaccine(s) other than Gardasil received within 24 months before the index date and personal/family history of ADs. RESULTS: Overall, 211 definite cases of ADs were matched to 875 controls. The adjusted odds ratio (OR) for any quadrivalent HPV vaccine use was 0.9 [95% confidence interval (CI) 0.5-1.5]. The individual ORs were 1.0 (95% CI 0.4-2.6) for ITP, 0.3 (95% CI 0.1-0.9) for MS, 0.8 (95% CI 0.3-2.4) for connective disorders and 1.2 (95% CI 0.4-3.6) for type 1 diabetes. No exposure to HPV vaccine was observed in cases with either Guillain-Barré syndrome or thyroiditis. CONCLUSIONS: No evidence of an increase in the risk of the studied ADs was observable following vaccination with Gardasil within the time periods studied. There was insufficient statistical power to allow conclusions to be drawn regarding individual ADs.

Telemedicine and type 1 diabetes: is technology per se sufficient to improve glycaemic control?

AIM: In the TELEDIAB-1 study, the Diabeo system (a smartphone coupled to a website) improved HbA1c by 0.9% vs controls in patients with chronic, poorly controlled type 1 diabetes. The system provided two main functions: automated advice on the insulin doses required; and remote monitoring by teleconsultation. The question is: how much did each function contribute to the improvement in HbA1c? METHODS: Each patient received a smartphone with an insulin dose advisor (IDA) and with (G3 group) or without (G2 group) the telemonitoring/teleconsultation function. Patients were classified as "high users" if the proportion of "informed" meals using the IDA exceeded 67% (median) and as "low users" if not. Also analyzed was the respective impact of the IDA function and teleconsultations on the final HbA1c levels. RESULTS: Among the high users, the proportion of informed meals remained stable from baseline to the end of the study 6months later (from 78.1±21.5% to 73.8±25.1%; P=0.107), but decreased in the low users (from 36.6±29.4% to 26.7±28.4%; P=0.005). As expected, HbA1c improved in high users from 8.7% [range: 8.3-9.2%] to 8.2% [range: 7.8-8.7%] in patients with (n=26) vs without (n=30) the benefit of telemonitoring/teleconsultation (-0.49±0.60% vs -0.52±0.73%, respectively; P=0.879). However, although HbA1c also improved in low users from 9.0% [8.5-10.1] to 8.5% [7.9-9.6], those receiving support via teleconsultation tended to show greater improvement than the others (-0.93±0.97 vs -0.46±1.05, respectively; P=0.084). CONCLUSION: The Diabeo system improved glycaemic control in both high and low users who avidly used the IDA function, while the greatest improvement was seen in the low users who had the motivational support of teleconsultations.

Effectiveness and tolerability of second-line therapy with vildagliptin vs. other oral agents in type 2 diabetes: a real-life worldwide observational study (EDGE).

AIM: Real-life studies are needed to confirm the clinical relevance of findings from randomised controlled trials (RCTs). This study aimed to assess the effectiveness and tolerability of vildagliptin add-on vs. other oral antihyperglycaemic drugs (OADs) added to OAD monotherapy in a real-life setting, and to explore the advantages and limitations of large-scale 'pragmatic' trials. METHODS: EDGE was a prospective, 1-year, worldwide, real-life observational study in which 2957 physicians reported on the effects of second-line OADs in 45,868 patients with T2DM not reaching glycaemic targets with monotherapy. Physicians could add any OAD, and patients entered either vildagliptin or (pooled) comparator cohort. The primary effectiveness and tolerability end-point (PEP) evaluated proportions of patients decreasing HbA(1c) > 0.3%, without hypoglycaemia, weight gain, peripheral oedema or gastrointestinal side effects. The most clinically relevant secondary end-point (SEP 3) was attainment of end-point HbA(1c) < 7% without hypoglycaemia or ≥ 3% increase in body weight. RESULTS: In this large group of T2DM patients, a second OAD was added at mean HbA(1c) of 8.2 ± 1.3%, with no baseline HbA(1c) difference between cohorts. Second-line OAD therapy attained the PEP in the majority of patients, with higher attainment in those prescribed a vildagliptin-based regimen. The adjusted odds ratio was 1.49 (95% CI: 1.42, 1.55; p < 0.001). In patients with baseline HbA(1c) ≥ 7%, SEP 3 was achieved by 35% of patients on a vildagliptin-based combination and by 23% of those receiving comparator combinations. The adjusted odds ratio was 1.96 (95% CI: 1.85, 2.07; p < 0.001). Safety events were reported infrequently and safety profiles of vildagliptin and other OADs were consistent with previous data. CONCLUSION: EDGE demonstrates that in a 'real-life' setting, vildagliptin as second OAD can lower HbA(1c) to target without well-recognised OAD side effects, more frequently than comparator OADs. In addition, EDGE illustrates that conducting large-scale, prospective, real-life studies poses challenges but yields valuable clinical information complementary to RCTs.

A new prognostic clinicopathological classification of pituitary adenomas: a multicentric case-control study of 410 patients with 8 years post-operative follow-up.

Pituitary adenomas are currently classified by histological, immunocytochemical and numerous ultrastructural characteristics lacking unequivocal prognostic correlations. We investigated the prognostic value of a new clinicopathological classification with grades based on invasion and proliferation. This retrospective multicentric case-control study comprised 410 patients who had surgery for a pituitary tumour with long-term follow-up. Using pituitary magnetic resonance imaging for diagnosis of cavernous or sphenoid sinus invasion, immunocytochemistry, markers of the cell cycle (Ki-67, mitoses) and p53, tumours were classified according to size (micro, macro and giant), type (PRL, GH, FSH/LH, ACTH and TSH) and grade (grade 1a: non-invasive, 1b: non-invasive and proliferative, 2a: invasive, 2b: invasive and proliferative, and 3: metastatic). The association between patient status at 8-year follow-up and age, sex, and classification was evaluated by two multivariate analyses assessing disease- or recurrence/progression-free status. At 8 years after surgery, 195 patients were disease-free (controls) and 215 patients were not (cases). In 125 of the cases the tumours had recurred or progressed. Analyses of disease-free and recurrence/progression-free status revealed the significant prognostic value (p < 0.001; p < 0.05) of age, tumour type, and grade across all tumour types and for each tumour type. Invasive and proliferative tumours (grade 2b) had a poor prognosis with an increased probability of tumour persistence or progression of 25- or 12-fold, respectively, as compared to non-invasive tumours (grade 1a). This new, easy to use clinicopathological classification of pituitary endocrine tumours has demonstrated its prognostic worth by strongly predicting the probability of post-operative complete remission or tumour progression and so could help clinicians choose the best post-operative therapy.

Intravenous infusion of donor apoptotic leukocytes before transplantation delays allogeneic islet graft rejection through regulatory T cells.

AIM: This study describes the ability of intravenous donor apoptotic leukocyte infusion before islet transplantation to delay allogeneic graft rejection and implicates regulatory T cells (T(reg)) in the effect. METHODS: Allogeneic FVB (Friend virus B-type) islet transplants were placed under the kidney capsule of BALB/c recipient mice rendered diabetic by streptozotocin. Apoptotic donor leukocytes were infused intravenously 7 days before transplantation. Foxp3/DTR/GFP transgenic C57BL/6 mice were used as recipients to show depletion of T(reg) after apoptotic cell infusion. Control mice received islet transplants without apoptotic cells. RESULTS: The graft median survival time (MST) in recipient mice was 15±1.5 days when apoptotic cells were infused 7 days prior to transplantation of a 1000-islet-containing allograft and 6±0.5 days in the control mice (P<0.01). The same effect was observed using a 500-islet allograft, with an MST of 9±1.1 days vs. 3±0.8 days with and without (controls) apoptotic cells, respectively (P<0.01). This immunomodulatory effect was not observed when apoptotic cell administration was performed on the day of transplantation. Specific T(reg) depletion in Foxp3/DTR/GFP recipient mice inhibited the beneficial effect of apoptotic cell infusion with an MST of 8±1.5 days after apoptotic cell infusion vs. 2±0.2 days when T(reg) were depleted (P<0.01). Furthermore, T(reg) were specifically detected in the islet grafts of mice infused with apoptotic cells prior to islet transplantation. CONCLUSION: Infusion of donor apoptotic cells 7 days before allogeneic transplantation delays islet allograft rejection through a process involving T(reg).

Comparison of stepwise addition of prandial insulin to a basal-bolus regimen when basal insulin is insufficient for glycaemic control in type 2 diabetes: results of the OSIRIS study.

AIM: The metabolic efficacy of adding prandial insulin in a stepwise manner to a straightforward basal-bolus regimen was compared in patients with type 2 diabetes mellitus (T2DM), suboptimally controlled by oral antidiabetic drugs (OADs) and once-daily basal insulin. METHODS: In this international randomized, parallel-group, non-inferiority study, 811 patients with poorly controlled type 2 diabetes using basal insulin were switched to insulin glargine (GLAR) for 6 months while continuing OADs. Patients with HbA(1c) > 7% and FPG < 120 mg/dL (n=476) were then randomized to either group 1, GLAR+metformin (MET)+3×insulin glulisine (GLU), group 2, GLAR+MET+1-3×GLU, or group 3, GLAR+MET+insulin secretagogue (IS)+1-3×GLU, for 12 months. Objectives were to show the non-inferiority of efficacy of group 2 vs group 1 and vs group 3. Non-inferiority of group 2 vs group 1 was concluded if the upper limit of the 95% confidence interval (CI) for the HbA(1c) difference was ≤ to 0.4%. RESULTS: The adjusted HbA(1c) difference of group 2 vs 1 for the per-protocol population crossed the non-inferiority margin (0.228, 95% CI: -0.018-0.473). There was significantly less weight gain in group 2 compared with group 1, but adverse events were otherwise similar between the two groups. In patients with HbA(1c) < 8% at baseline, non-inferiority was achieved in group 2 vs group 1. CONCLUSION: Although non-inferiority was not achieved, stepwise intensification of GLU added to GLAR showed efficacy close to that of the basal-bolus approach and with significantly less weight gain.

Real-life comparison of DPP4-inhibitors with conventional oral antidiabetics as add-on therapy to metformin in elderly patients with type 2 diabetes: the HYPOCRAS study.

AIM: Despite half of all type 2 diabetes mellitus (T2DM) patients being over 65 and treatment being complicated by an elevated risk of iatrogenic hypoglycaemia, information about antidiabetic treatment is scarce in this age group. This prospective observational study compares DPP4-inhibitors (DPP4-i) with conventional oral antidiabetic drugs (COAD) in the real-life treatment of elderly patients with T2DM uncontrolled on metformin alone. METHODS: Two treatment cohorts (DPP4-i and COAD, constituted on the basis of the GP decision of add-on therapy at the 1st visit) were compared after 6months. The primary objective was to assess the incidence of hypoglycaemic episodes in relationship with glycaemic control assessed by HbA(1c) level. RESULTS: Demographics and disease history were comparable between the two cohorts (DPP4-i, n=931 and COAD, n=257) at baseline. The incidence of hypoglycaemia/severe hypoglycaemia was significantly higher over 6months in the COAD cohort (20.1%/2.4% vs. 6.4%/0.1%; P<0.001) whereas similar improvements were observed in glycaemic control with HbA(1c) down from 7.9% to 7.0% (COAD) and 6.9% (DPP4-i). The 7% target was reached without hypoglycaemia in more patients in the DPP4-i than in COAD cohort (59.7% vs. 45.5%; P<0.001). Patients in both cohorts who experienced hypoglycaemia more frequently had a pre-existing diabetic complication. The COAD was more likely to be discontinued (6.6% vs. 1.6%; P<0.001). CONCLUSION: This large cohort study of elderly T2DM patients in France shows that the incidence of hypoglycaemia was three times higher in patients prescribed a COAD versus a DPP4-i after 6months while both treatments induced satisfactory glycaemic control.

Quality of care of patients with type 1 diabetes: population-based results in a French region.

AIM: Although the incidence of type 1 diabetes (T1D) has been increasing, little is known of its quality of care. Thus, our survey was designed to retrospectively evaluate this issue in French patients. METHODS: Patients with T1D living in northeastern France were identified thanks to the healthcare system (CPAM) database, and the resulting list reviewed by local diabetes specialists. All of the listed patients and their primary physicians were asked to fill in a questionnaire including clinical data, laboratory results and follow-up habits. The 'optimized results' included CPAM-based results plus any specialized care provided during hospitalizations in diabetes and non-diabetes units, according to questionnaire data. RESULTS: A total of 227 individuals, for whom CPAM data were available, were identified as having T1D. From these patients, 174 questionnaires were answered, and optimized results (having both CPAM data and a completely filled-in questionnaire) were available for 149 patients. Of the 169 patients who responded, 71.3% reported at least a yearly visit with a diabetologist. This number reached 77.9% when optimized results were considered. Patients who received specialized care were younger, underwent HbA(1c) tests more often and were more frequently on optimal treatment; however, there was no difference in HbA(1c) values or in the prevalence of complications. Eye examinations and kidney tests had been performed at least once over the 2-year period in more than 87% of the patients, whereas around 30%, 21% and 23% had an eye exam, creatinine test and urinary albumin excretion measurement, respectively, only once over the same time period. CONCLUSION: This is the first large-scale study of the quality of care in patients with T1DM in France, and it could serve as a preliminary survey for a national study. Although the follow-up was better than previously reported, there is still considerable room for improvement.

Insulin therapy for diabetes mellitus: treatment regimens and associated costs.

AIMS: To describe insulin therapy in patients with diabetes, to determine treatment costs and to compare costs among treatment regimens. METHODS: This observational study was performed by 734 French pharmacists. Adult patients filling an insulin prescription were invited to participate. Participants provided information on their diabetes history and management. Levels of intensification of insulin therapy were determined by the number of injections in type 1 diabetes mellitus (T1DM) patients, and by the different schemes used in type 2 (T2DM) patients, such as basal/intermediate-acting insulin only, and regimens using both basal and rapid-acting insulin. Costs were evaluated according to official medication costs, nurse visits and glucose monitoring kits. RESULTS: A total of 361 patients with T1DM and 1902 with T2DM were enrolled in the survey. Patients with T1DM more frequently took 1-2 injections per day (46.3% of patients) and used single-dose basal insulin together with ≥1 dose of rapid insulin (43.8%). Patients with T2DM used multiple treatment regimens, with 58 different combinations documented. Most took basal/intermediate insulin only (42.5%) or combinations of basal/intermediate and rapid insulins (52.7%). Mean cost of insulin therapy was €27.4/week for T1DM and €45.4/week for T2DM. In T1DM, insulin was the biggest cost component and increased with the number of injections/day. In T2DM, nurse visits were the most important cost contributors irrespective of treatment regimen. Overall, the cost of insulin therapy increased with the complexity of the insulin schemes. CONCLUSION: Considerable heterogeneity is found in insulin treatment regimens used in everyday diabetes care. Payers should consider the full costs associated with the use of insulin rather than the cost of insulin alone. Treatment algorithms to harmonize insulin therapy should help to improve care, while encouraging patients to self-inject insulin should help to reduce costs.

Current insulin therapy in patients with type 2 diabetes: results of the ADHOC survey in France.

AIM: In France, the Afssaps/HAS 2006 guidelines for insulin-treated type 2 diabetic patients recommend a target glycated haemoglobin level (HbA(1c)) of less than 7%, achieved by optimalizing the insulin dose or increasing the number of daily injections. The present study investigated to what extent these recommendations are followed in clinical practice by general practitioners (GPs) and diabetologists (DTs). METHODS: The ADHOC study (observational, transversal) was a survey of 267 GPs and 180 DTs prescribing insulin in France (participation rate: 4.45% and 11.6% of GPs and DTs, respectively). Physicians answered a questionnaire focused on aspects of insulin therapy in type 2 diabetic patients receiving oral antidiabetic drugs (OADs) and insulin for at least six months. RESULTS: A total of 1874 patients were included in the study (959 from GPs and 915 from DTs). Insulin was initiated about 10 years after the diagnosis of diabetes, when patients had high HbA(1c) levels (mean value: 9.2%). At the time of the survey, patients had been treated with insulin for 3.4 ± 3.5 years (mean ± SD), and the mean HbA(1c) was significantly reduced (P<0.05) to 7.8% and 7.9% in patients treated by GPs and DTs, respectively. However, almost 80% of patients had HbA(1c) levels greater than 7%, and 35% had levels greater than 8%. The last fasting blood glucose level was 144 ± 45 mg/dL. More than 60% of patients with HbA(1c) greater than 8% were using single daily injection therapy. On consultation day, insulin treatment (dose, number of injections and type of insulin) was not optimalized in more than 40% of the latter patients. Differences in data between patients treated by GPs and DTs were small and often not statistically significant. CONCLUSION: In this study, the main therapeutic goals of insulin therapy, as defined by the Afssaps/HAS 2006 guidelines, were only attained in around 20% of type 2 diabetic patients, irrespective of follow-up by a GP or DT. During consultation, insulin therapy was not optimalized in a large proportion of inadequately controlled patients.

The potential role of glucagon-like peptide-1 or its analogues in enhancing glycaemic control in critically ill adult patients.

Intravenous insulin therapy is the gold standard therapy for glycaemic control in hyperglycaemic critically ill adult patients. However, hypoglycaemia remains a major concern in critically ill patients, even in some populations who are not receiving infused insulin. Furthermore, the influence of factors such as glycaemic variability and nutritional support may conceal any benefit of strict glycaemic control on morbidity and mortality in these patients. The recently revised guidelines of the American Diabetic Association/American College of Clinical Endocrinologists no longer advocate very tight glycaemic control or normalization of glucose levels in all critically ill patients. In the light of various concerns over the optimal glucose level and means to achieve such control, the use of glucagon-like peptide-1 or its analogues administered intravenously may represent an interesting therapeutic option.

Feasibility of screening for silent myocardial ischaemia according to the ALFEDIAM-SFC 2004 Guidelines in a population of diabetic patients.

BACKGROUND: Screening tests have to meet a number of criteria, including feasibility. The aim of this study was to estimate the proportion of the French diabetic population that is eligible for screening for silent myocardial ischaemia (SMI), and to evaluate the feasibility of such screening in the Franche-Comté region. METHODS: Data were taken from the Echantillon National Témoin Représentatif de la Population Diabétique (ENTRED, a Representative National Sample of the Diabetic Population 2001 study), which was based on questionnaires filled out by 3646 diabetic patients. All screening tests carried out in the region of Franche-Comté in eastern France in 2003 were recorded (n=19,216). RESULTS: The guidelines issued by the ALFEDIAM-SFC in 2004 were applied to the ENTRED population and identified 645 diabetic patients (17%) as eligible for SMI screening. When applied to the region of Franche-Comté, the recommendations would have required screening 7480 diabetic patients over a period of 3years, involving 1246 exercise stress tests and 1246 myocardial perfusion or stress echocardiography studies annually. However, more than 14,653 exercise stress, 4248 myocardial perfusion and 315 stress echocardiography tests were carried out in the region in 2003 among diabetic and non-diabetic patients, thus largely covering the screening requirements. On the other hand, ENTRED 2001 data also showed that 60% of patients who reported existing coronary disease would not have met screening criteria. CONCLUSION: The number of examinations carried out in the region of Franche-Comté greatly exceeded the number of patients required for screening. However, practical feasibility is not the only criterion needed to guarantee the quality of a large-scale screening programme. Our results raise the question of the relevance of the current screening selection criteria.

Efficacy and safety of an insulin infusion protocol during and after cardiac surgery.

AIM: Perioperative tight blood glucose (BG) control using insulin therapy after major surgery is a difficult, time-consuming task that also raises some concerns over the risk of severe hypoglycaemia. The aim of the present prospective study was to evaluate the efficacy and safety of an insulin therapy protocol in use at our institution. METHODS: A total of 230 consecutive patients (mean+/-SD age: 67+/-11 years; diabetic patients: n=62) undergoing cardiac surgery (coronary artery bypass grafting: n=137; 20% off-pump) or intrathoracic aortic (n=10) surgery were included. BG control was managed according to an insulin therapy protocol, described by Goldberg et al. (2004) [11], in use for 6 months in our intensive care unit. Insulin infusion rate and frequency of BG monitoring were both adjusted according to: (1) the current BG value; (2) the previous BG value; and (3) the current insulin infusion rate. Efficacy was assessed by the percentage of time spent at the target BG level (100-139 mg/dL) intraoperatively and during the first 2 postoperative days (POD). RESULTS: All patients received postoperative insulin therapy. Patients spent 57.3% and 69.7% of time within the BG target range on POD 1 and 2, respectively. The percentage of time was significantly higher in nondiabetics than in diabetics. Mean BG measurements per patient intraoperatively, on POD 1 and on POD 2 were 4+/-1, 10+/-2 and 7+/-2, respectively. No patient experienced any severe hypoglycaemic events (BG<50mg/dL). CONCLUSION: This study showed that a BG target of 100-139 mg/dL can be safely achieved with an insulin therapy protocol that can be routinely used in everyday clinical practice.

[Complete resolution of insulin-dependent diabetes mellitus in a patient with autoimmune pancreatitis following treatment with corticosteroids]. / Disparition totale d'un diabète insulinorequérant au décours d'une pancréatite auto-immune traitée par corticothérapie.

We report here the observation of a 60-year-old man who had an autoimmune pancreatitis revealed by a jaundice, in whom an insulin-treated diabetes mellitus, which was diagnosed one month before, completely resolved after the administration of prednisolone given to treat this symptomatic pancreatitis. Neither the symptoms, nor the diabetes have relapsed after a 3-year follow-up.