Diabetic ketoacidosis is a life-threatening condition and is generally preventable through close glucose monitoring. Initiation of the FreeStyle Libre™ system could prevent ketoacidosis. We conducted ...a retrospective study of the ketoacidosis rates (ICD-10 codes E10.1, E11.1) on the French exhaustive nationwide reimbursement claim database in FreeStyle Libre system initiators (reimbursed from 2017/06/01). Ketoacidosis rates were recorded in the year prior to first FreeStyle Libre sensor claim (index date for initiation), and in the year after. We identified 33,203 and 40,955 people with type 1 and type 2 diabetes, respectively, initiating the FreeStyle Libre system during the study period (2017/08/01 to 2017/12/31). Overall, yearly ketoacidosis rates were reduced after FreeStyle Libre system initiation by 52% for type 1 and 47% for type 2 diabetes. Results are also presented according to the mean daily number of SMBG strips reimbursed, estimated for the year prior to FreeStyle Libre system initiation (Figure). It is plausible that the use of the FreeStyle Libre system allowed people to detect and limit persistent hyperglycemia, and subsequently ketoacidosis. The reduction of rates was marked for both types of diabetes, especially for people with very low and very high adherence to SMBG.
Disclosure
R. Roussel: Advisory Panel; Self; Abbott, AstraZeneca, Diabnext, Eli Lilly and Company, Merck & Co., Inc., Mundipharma International, Novo Nordisk A/S, Sanofi-Aventis. B. Guerci: Board Member; Self; Abbott. E. Vicaut: Consultant; Self; Abbott, Boston Scientific, Celgene, Pfizer Inc. G. Depouvourville: Advisory Panel; Self; Abbott, AbbVie Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Merck Sharp & Dohme Corp. Consultant; Self; Abbott, AbbVie Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Merck Sharp & Dohme Corp. B. Detournay: Advisory Panel; Self; Merck Sharp & Dohme Corp., Novo Nordisk A/S. Consultant; Self; Lilly Diabetes, Merck Sharp & Dohme Corp., Pfizer Inc., Sanofi. Employee; Self; CEMKA. C. Emery: Employee; Self; CEMKA. F. Levrat-Guillen: Employee; Self; Abbott. J. Riveline: None.
Primary hyperparathyroidism is associated with an increased cardiovascular mortality, and its underlying mechanisms remain unclear. Insulin resistance has been suggested with low level of evidence. ...The goal of this study was to evaluate glucose metabolism and insulin resistance in primary hyperparathyroidism patients, to compare with control subjects, and to identify risk factors for insulin resistance in patients with primary hyperparathyroidism.
Cross-sectional study of consecutive primary hyperparathyroidism patients without history of diabetes or severe chronic kidney disease (glomerular filtration rate ≤30 mL/min/1.73 m2). Fasting glucose and insulin were evaluated before parathyroidectomy. Glucose metabolism was compared with population-based control subjects (n = 171).
One hundred and seventy-four patients with primary hyperparathyroidism (140 females) were included. Mean fasting glucose was 0.983 ± 0.129 g/L, and 63 patients (36%) had prediabetes (>1.0 g/L). Mean Homeostatic model assessment of insulin resistance (HOMA-IR) was 3.386 ± 3.111 mUI/L, and 78 patients (45%) had insulin resistance (HOMA-IR >2.6). Blood calcium levels (0.171; P = .023) and body mass index (0.450; P < .001) were correlated positively with HOMA-IR. Insulin secretion (HOMA-B%) was correlated positively with preoperative systolic blood pressure in mm Hg (0.187; P = .013). In multivariate analysis, classic hypercalcemic primary hyperparathyroidism (18.47, 6.84–49.87; <.001), mild hypercalcemic primary hyperparathyroidism (5.35, 2.40–11.95; <.001), and body mass index (1.27, 1.17–1.38; <.001) remained independent predictors for insulin resistance (HOMA-IR >2.6). When compared with control subjects, mean HOMA-IR was significantly higher in primary hyperparathyroidism patients (3.386 ± 3.111 vs 1.919 ± 1.158; P < .001).
Insulin resistance was significantly higher in primary hyperparathyroidism patients than in control subjects. The impact of parathyroidectomy on insulin resistance should be evaluated in patients with higher calcium levels.
Data on patient-reported outcome (PRO) measures in people living with T2D who initiate injectable glucagon-like peptide-1 receptor agonist (GLP-1 RA) medication in routine clinical practice are ...limited. Here we present final PRO data from the TROPHIES 24-month, prospective, non-comparative, observational study of adult patients with T2D in France, Germany and Italy who started their first injectable GLP-1 RA with either once-weekly dulaglutide (DU) or once-daily liraglutide (LIRA) . Patients’ scores on PRO questionnaires were assessed every 6 months. We present scores at 24 months compared with baseline values before starting DU or LIRA treatment. For each PRO measure, higher scores reflect better outcomes. Baseline characteristics (previously published) for patients prescribed DU (N=1,014) or LIRA (N=991) were similar between groups. Mean changes from baseline to 24 months in PRO scores indicate improvements in health outcomes in patients initiating DU or LIRA (Table) .
In summary, among those patients still evaluable at 24 months we observed improvements in PRO scores from baseline in both groups, but with a more pronounced trend of improvement in the DU cohort for EQ-5D-5L VAS, IW-SP, DTSQs total, and DPM life and work productivity scores.
Disclosure
M.Fuechtenbusch: Advisory Panel; Berlin-Chemie AG, Consultant; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Speaker's Bureau; AstraZeneca, Novo Nordisk. K.Boye: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. B.Guerci: Advisory Panel; Amgen Inc., Medtronic, Board Member; Abbott Diagnostics, AstraZeneca, Bayer AG, Eli Lilly and Company, Novartis Pharmaceuticals Corporation, Consultant; Boehringer Ingelheim International GmbH, Intercept Pharmaceuticals, Inc., Novo Nordisk. F.Giorgino: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk, Consultant; Lilly Diabetes, Sanofi, Research Support; Lilly Diabetes, Roche Diabetes Care, Takeda Pharmaceutical Company Limited. L.Garcia-perez: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. E.Heitmann: None. J.Lebrec: Consultant; Eli Lilly and Company. A.Barrett: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. A.Dib: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. M.Orsini federici: Employee; Eli Lilly and Company.
TROPHIES was a 24-month, prospective, non-comparative, observational study in adult patients with T2D initiating their first injectable glucose-lowering treatment with once-weekly dulaglutide (DU; ...N=1,014) or once-daily liraglutide (LIRA; N=991) in France, Germany, and Italy. Secondary objectives included assessments of HbA1c, body weight and treatment patterns. Clinical characteristics of the DU and LIRA cohorts at 24 months are described in the Table. Most patients receiving DU (856/1,014) initiated treatment at 1.5 mg/week and, among 286 patients with a significant treatment change, 237 were still receiving 1.5 mg/week. In the LIRA cohort, most patients (809/991) initiated at the starting dose 0.6 mg/day and 45% increased dose to 1.2 mg/day by Day 90; however, 17% of patients were already receiving 1.8 mg/day by Day 90. At the first significant treatment change 285/448 patients in the LIRA cohort were receiving 1.2 mg/day. Insulin was initiated by 79 and 97 patients in the DU and LIRA cohorts, respectively. Both treatments showed clinically meaningful effectiveness on HbA1c and weight, maintained over the 24-month study period.
Disclosure
B. Guerci: Advisory Panel; Amgen Inc., Medtronic. Board Member; Abbott Diagnostics, AstraZeneca, Bayer AG, Eli Lilly and Company, Novartis Pharmaceuticals Corporation. Consultant; Boehringer Ingelheim International GmbH, Intercept Pharmaceuticals, Inc., Novo Nordisk. F. Giorgino: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk. Consultant; Lilly Diabetes, Sanofi. Research Support; Lilly Diabetes, Roche Diabetes Care, Takeda Pharmaceutical Company Limited. K. Boye: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. M. Fuechtenbusch: Advisory Panel; Berlin-Chemie AG. Consultant; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp. Speaker's Bureau; AstraZeneca, Novo Nordisk. E. Heitmann: None. J. Lebrec: Consultant; Eli Lilly and Company. A. Dib: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. M. Orsini Federici: Employee; Eli Lilly and Company. M. Yu: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. L. Garcia-Perez: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company.
TROPHIES was a 24-month, prospective, non-comparative, observational study in adult patients with T2D initiating their first injectable glucose-lowering treatment with once-weekly dulaglutide (DU; ...N=1,014) or once-daily liraglutide (LIRA; N=991) in France, Germany, and Italy. Primary objective: to assess the time patients remained on their first GLP-1 RA without a significant treatment change due to treatment- or diabetes-related factors. Kaplan-Meier (KM) probability (95% CI) of no significant treatment change at 24 months was 0.71 (0.68-0.74) and 0.53 (0.49-0.56) in the DU and LIRA cohorts, respectively (Figure) . Two-hundred and eighty-six (28.2%) and 448 (45.2%) patients receiving DU and LIRA, respectively, had a significant treatment change. The main driver of treatment change in the DU and LIRA cohorts was intensification with an add-on therapy (insulin or OAD) and intensification with dose increase of GLP-1 RA, respectively. KM probability (95% CI) of GLP-1 RA persistence at 24 months was high in both cohorts: DU 0.82 (0.80-0.85) ; LIRA 0.75 (0.72-0.78) .
In summary, the probabilities of no significant treatment change over 24 months were estimated as higher in the DU cohort than in the LIRA cohort in this non-comparative analysis, with good persistence in both cohorts.
Disclosure
F. Giorgino: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk. Consultant; Lilly Diabetes, Sanofi. Research Support; Lilly Diabetes, Roche Diabetes Care, Takeda Pharmaceutical Company Limited. B. Guerci: Advisory Panel; Amgen Inc., Medtronic. Board Member; Abbott Diagnostics, AstraZeneca, Bayer AG, Eli Lilly and Company, Novartis Pharmaceuticals Corporation. Consultant; Boehringer Ingelheim International GmbH, Intercept Pharmaceuticals, Inc., Novo Nordisk. L. Garcia-Perez: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. M. Fuechtenbusch: Advisory Panel; Berlin-Chemie AG. Consultant; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp. Speaker's Bureau; AstraZeneca, Novo Nordisk. J. Lebrec: Consultant; Eli Lilly and Company. M. Orsini Federici: Employee; Eli Lilly and Company. A. Dib: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. E. Heitmann: None. M. Yu: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. K. Boye: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company.
Objective To assess the effectiveness of self monitoring blood glucose levels in people with non-insulin treated type 2 diabetes compared with clinical management without self monitoring, and to ...explore the effects in specific patient groups.Design Meta-analysis based on individual participant data.Data sources Medline, Embase, and a recent systematic review of trials on self monitoring of blood glucose. Chief investigators of trials published since 2000 were approached for additional information and individual patient data.Inclusion criteria Randomised controlled trials in patients with non-insulin treated type 2 diabetes comparing an intervention using self monitoring of blood glucose with clinical management not using self monitoring. Trials published from 2000 with at least 80 participants were included.Data collection Individual patient data were collected from electronic files and checked for integrity.Analysis All randomised participants were analysed using the intention to treat principle. A random effects model of complete cases was used to assess efficacy, a sensitivity analysis comprised imputed data, and prespecified subgroup analyses were carried out for age, sex, previous use of self monitoring, duration of diabetes, and levels of glycated haemoglobin (HbA1c) at baseline.Results 2552 patients were randomised in the six included trials. A mean reduction in HbA1c level of −2.7 mmol/mol (95% confidence interval −3.9 to −1.6; 0.25%) was observed for those using self monitoring of blood glucose levels compared with no self monitoring at six months. The mean reduction in HbA1c level between groups was 2.0 mmol/mol (3.2 to 0.8; 0.25%) at three months (five trials) and 2.5 mmol/mol (4.1 to 0.9; 0.35%) at 12 months (three trials). These estimates were unchanged after imputing missing data, and estimates of effect in trials with higher loss to follow-up or a possibility of co-intervention compared with those with lower loss to follow-up and no co-intervention did not differ significantly (P=0.21). The difference in HbA1c levels between groups was consistent across age, baseline HbA1c level, sex, and duration of diabetes, although the numbers of older and younger people and those with HbA1c levels >86 mmol/mol (10%) were insufficient for interpretation. No changes occurred in systolic blood pressure (−0.2 mm Hg, 95% confidence interval −1.4 to 1.0), diastolic blood pressure (−0.1 mm Hg, −0.9 to 0.6), or total cholesterol level (−0.1 mol/L, 95% confidence interval −0.2 to 0.1).Conclusions Evidence from this meta-analysis of individual patient data was not convincing for a clinically meaningful effect of clinical management of non-insulin treated type 2 diabetes by self monitoring of blood glucose levels compared with management without self monitoring, although the difference in HbA1c level between groups was statistically significant. The difference in levels was consistent across subgroups defined by personal and clinical characteristics.
AimsThe primary objective of the TROPHIES observational study is to estimate the duration of treatment on dulaglutide or liraglutide without a significant treatment change by 24 months in patients ...with type 2 diabetes (T2D) initiating their first injectable treatment with these glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs). This manuscript presents 12‐month interim data.Materials and MethodsTROPHIES is a prospective, non‐comparative, observational study of patients with T2D in Europe, naïve to injectable antihyperglycaemic treatments and initiating dulaglutide or liraglutide. Data on clinical characteristics, GLP‐1 RA persistence and treatment patterns of glucose‐lowering medication were collected at initiation of first injectable therapy and by 12 months.ResultsBy 12 months, 1014 dulaglutide and 991 liraglutide patients were eligible across France, Germany and Italy. Both cohorts presented a high probability 95% confidence interval (CI) of GLP‐1 RA persistence dulaglutide, 0.88 (0.86 to 0.90); liraglutide, 0.83 (0.80 to 0.85) and reduction in mean glycated haemoglobin percentage (95% CI) from baseline dulaglutide, −1.18 (−1.27 to −1.08); liraglutide, −1.15 (−1.26 to −1.05) with 48.2% of dulaglutide and 41.2% of liraglutide patients reaching their individualized glycated haemoglobin percentage target set by the physician at baseline. Mean weight (95% CI) change from baseline was −3.2 kg (−3.6 to −2.8) for dulaglutide and −3.4 kg (−3.9 to −3.0) for liraglutide. Slight changes in concomitant medications were observed compared with baseline.ConclusionsIn the real‐world setting, dulaglutide and liraglutide cohorts achieved good persistence with similarly improved glycaemic control that was accompanied by weight loss at 12 months, consistent with previous clinical trial results.
Type 2 diabetes mellitus (T2DM) is a frequent comorbidity in patients with cirrhosis that is projected to rise in prevalence due to the worldwide burden of obesity, insulin-resistance and ...non-alcoholic fatty liver disease. The management of T2DM in patients with cirrhosis is complex given the requirement for accurate adaptation according to the level of liver function impairment, with lack of summary of the little evidence available in the literature. Here, we summarise the data available with respect to the epidemiology and the impact of T2DM in patients with cirrhosis, as well as those on the management of T2DM in these patients. We provide guidance for the diagnosis of T2DM and the monitoring of glycaemic control in patients with cirrhosis, and for the management of nutrition and pharmacological treatments in relation to the level of liver dysfunction.
Introduction
This study aimed to determine, in close to real-life conditions, the efficacy and safety of switching from any basal insulin to insulin glargine 300 U/mL (Gla-300) in patients with ...uncontrolled type 2 diabetes (T2D).
Methods
This was an interventional, multicenter, single-arm, prospective study with a 24-week treatment phase. Adult patients with T2D treated with basal insulin with or without other antidiabetics, HbA1c > 7.5%, and fasting self-monitored blood glucose (F-SMBG) > 130 mg/dL (mean of three measures) at baseline were included. Insulin dose was titrated to reach F-SMBG 90–130 mg/dL. Efficacy and safety were assessed at 12 weeks (W12) and 24 weeks (W24). The main outcome parameter was HbA1c change between baseline and W24. Safety parameters included self-reported hypoglycemia (any type). Patients’ satisfaction with the treatment was assessed by the Diabetes Treatment Satisfaction Questionnaire (DTSQ).
Results
A total of 140 patients were included and 137 were treated. Mean HbA1c decreased from 8.64% at baseline to 8.14% at W12 (mean difference 95% CI − 0.51% − 0.64; − 0.38) and 8.01% at W24 (− 0.64% − 0.81; − 0.46). Target F-SMBG was reached in 35.0% of the patients at W12 and 38.4% at W24. The percentages of patients reaching HbA1c levels < 7.0%, < 7.5%, and < 8.0% at W24 were 11.4%, 29.5%, and 50.8%, respectively, while only 31.6% had an HbA1c value < 8.0% at baseline. HbA1c reduction was greater in patients with higher baseline levels. During the treatment phase, 46.0% of the participants had at least one hypoglycemia event; 31.4% documented symptomatic hypoglycemia, 2.2% severe hypoglycemia, and 12.2% nocturnal hypoglycemia. Treatment satisfaction increased by 20% between baseline and W24.
Conclusion
These data, derived from close to real-life practice in France, confirm the reassuring results of randomized trials on the efficacy and safety of Gla-300.
Trial Registration
EudraCT number 2015-002416-33.
TROPHIES is a 24-month, prospective, non-comparative, observational study in adult patients with T2D initiating their first injectable glucose-lowering treatment with once-weekly dulaglutide (DU) or ...once-daily liraglutide (LIRA) in France, Germany, and Italy. Patient disposition, clinical characteristics, and GLP-1 RA persistence at 12-months are described for 1112 DU and 1039 LIRA patients eligible for analysis. The 12-month mean HbA1c (SD) change from baseline was -1.2 (1.4)% (baseline, 8.2 (1.2)%) in the DU cohort and -1.2 (1.5)% (baseline, 8.3 (1.3)%) in the LIRA cohort. At 12-months, 35% DU and 29% LIRA patients reached their individualized HbA1c target set by the physician at baseline. The mean weight change for DU and LIRA from baseline to 12-months was -3.3 (5.5) kg and -3.4 (6.1) kg, respectively. Probability (95%CI) of GLP-1 RA persistence was high in both DU and LIRA cohorts at 12-months: DU, 0.88 (0.86-0.90); LIRA 0.82 (0.79-0.84); (Figure). In summary, these data show similar HbA1c and weight reductions for DU and LIRA at 12-months with good persistence, consistent with known clinical trial results.
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