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AIMS: To describe healthcare resource utilization (HCRU) and associated costs after initiation of injectable glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy by adult patients with type 2 diabetes (T2D) in the prospective, observational, 24-month TROPHIES study in France, Germany, and Italy. MATERIALS AND METHODS: HCRU data for cost calculations were collected by treating physicians during patient interviews at baseline and follow-up visits approximately 6, 12, 18, and 24 months after GLP-1 RA initiation with once-weekly dulaglutide or once-daily liraglutide. Costs were evaluated from the national healthcare system (third-party payer) perspective and updated to 2018 prices. RESULTS: In total, 2,005 patients were eligible for the HCRU analysis (1,014 dulaglutide; 991 liraglutide). Baseline patient characteristics were generally similar between treatment groups and countries. The largest proportions of patients using ≥2 oral glucose-lowering medications (GLMs) at baseline (42.9-43.4%) and month 24 (44.0-45.1%) and using another injectable GLM at month 24 (15.3-23.2%) were in France. Mean numbers of primary and secondary healthcare contacts during each assessment period were highest in France (range = 4.0-10.7) and Germany (range = 2.9-5.7), respectively. The greatest proportions (≥60%) of mean annualized costs per patient comprised medication costs. Mean annualized HCRU costs per patient varied by treatment cohort and country: the highest levels were in the liraglutide cohort in France (909) and the dulaglutide cohort in Germany (883). LIMITATIONS: Limitations included exclusion of patients using insulin at GLP-1 RA initiation and collection of HCRU data by physician, not via patient-completed diaries. CONCLUSIONS: Real-world HCRU and costs associated with the treatment of adults with T2D with two GLP-1 RAs in TROPHIES emphasize the need to avoid generalization with respect to HCRU and costs associated with a particular therapy when estimating the impact of a new treatment in a country-specific setting.
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have become frequent treatments of hyperglycemia in type-2 diabetes (T2D). Not all types of clinical study provide information about the cost of these treatments or the effects they might have on use of other medicines and equipment to control T2D or the need for visits to a doctor or nurse and different types of treatment in hospital. This study collected this information during the regular care of adults in France, Germany, or Italy who were prescribed either dulaglutide or liraglutide (both types of GLP-1 RAs) by their family doctor or a specialist in T2D. There were differences in costs and the need for other medicines and medical services between people using either dulaglutide or liraglutide and for people who were using the same GLP-1 RA in each of the three countries. The information from this study could be used to more accurately understand the overall costs and medical care needed when patients use dulaglutide or liraglutide in France, Germany, or Italy.
Subject(s)
Diabetes Mellitus, Type 2 , Glucagon-Like Peptides , Hypoglycemic Agents , Immunoglobulin Fc Fragments , Liraglutide , Recombinant Fusion Proteins , Humans , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/economics , Liraglutide/therapeutic use , Liraglutide/economics , Glucagon-Like Peptides/analogs & derivatives , Glucagon-Like Peptides/therapeutic use , Glucagon-Like Peptides/economics , Glucagon-Like Peptides/administration & dosage , Immunoglobulin Fc Fragments/therapeutic use , Immunoglobulin Fc Fragments/economics , Recombinant Fusion Proteins/economics , Recombinant Fusion Proteins/therapeutic use , Recombinant Fusion Proteins/administration & dosage , Male , Hypoglycemic Agents/therapeutic use , Hypoglycemic Agents/economics , Female , Prospective Studies , Middle Aged , Aged , Health Resources/statistics & numerical data , Health Resources/economics , Models, EconometricABSTRACT
Objective: Glycemic management in people with type 2 diabetes mellitus (T2DM) on insulin-secretagogue regimens without insulin is of importance, as this group still represents a significant proportion of patients. Risks for acute diabetes events (ADEs), including diabetic ketoacidosis (DKA) or hypoglycemia, using insulin-secretagogue drugs are well established. Few studies have suggested that continuous glucose monitoring (CGM) could be useful for monitoring glucose dynamics associated with the use of such therapies. To document this point an exploratory analysis was conducted in a group of individuals with noninsulin treated T2DM in France who are managed with oral insulin-secretagogues and initiating the FreeStyle Libre® system (FSL). Methods: A retrospective study of the French national SNDS reimbursement claims database (≈66 million French people) was conducted to identify people with T2DM on oral insulin-secretagogues and receiving a first reimbursement of FSL between August 1, 2017 and December 31, 2018. The analysis included data for the 12 months before and up to 24 months after FSL initiation. Hospitalizations for diabetes-related acute events were identified using ICD-10 codes as main or related diagnosis, for: hypoglycemic events; DKA events; comas; and hyperglycemia-related admissions. Results: A total of 1272 people with T2DM on insulin-secretagogues without insulin initiated FSL during the selection period. Of these, 7.15% had at least one hospitalization for any ADE in the year before FSL initiation, compared with 2.52% at 12 months and 2.83% at 24 months following FSL initiation. Reductions in ADEs were driven by -73% fewer admissions for ADEs related to diabetic ketoacidosis (DKA) or other hyperglycemia-related events. These patterns of reduced ADEs persisted after 2 years. Conclusions: This study suggests the value of the FSL system in reducing ADEs in some people with T2DM in France being treated with insulin-secretagogues without insulin. Characteristics of these patients remain to be documented.
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AIMS/HYPOTHESIS: Our study aims to uncover glycaemic phenotype heterogeneity in type 1 diabetes. METHODS: In the Study of the French-speaking Society of Type 1 Diabetes (SFDT1), we characterised glycaemic heterogeneity thanks to a set of complementary metrics: HbA1c, time in range (TIR), time below range (TBR), CV, Gold score and glycaemia risk index (GRI). Applying the Discriminative Dimensionality Reduction with Trees (DDRTree) algorithm, we created a phenotypic tree, i.e. a 2D visual mapping. We also carried out a clustering analysis for comparison. RESULTS: We included 618 participants with type 1 diabetes (52.9% men, mean age 40.6 years [SD 14.1]). Our phenotypic tree identified seven glycaemic phenotypes. The 2D phenotypic tree comprised a main branch in the proximal region and glycaemic phenotypes in the distal areas. Dimension 1, the horizontal dimension, was positively associated with GRI (coefficient [95% CI]) (0.54 [0.52, 0.57]), HbA1c (0.39 [0.35, 0.42]), CV (0.24 [0.19, 0.28]) and TBR (0.11 [0.06, 0.15]), and negatively with TIR (-0.52 [-0.54, -0.49]). The vertical dimension was positively associated with TBR (0.41 [0.38, 0.44]), CV (0.40 [0.37, 0.43]), TIR (0.16 [0.12, 0.20]), Gold score (0.10 [0.06, 0.15]) and GRI (0.06 [0.02, 0.11]), and negatively with HbA1c (-0.21 [-0.25, -0.17]). Notably, socioeconomic factors, cardiovascular risk indicators, retinopathy and treatment strategy were significant determinants of glycaemic phenotype diversity. The phenotypic tree enabled more granularity than traditional clustering in revealing clinically relevant subgroups of people with type 1 diabetes. CONCLUSIONS/INTERPRETATION: Our study advances the current understanding of the complex glycaemic profile in people with type 1 diabetes and suggests that strategies based on isolated glycaemic metrics might not capture the complexity of the glycaemic phenotypes in real life. Relying on these phenotypes could improve patient stratification in type 1 diabetes care and personalise disease management.
Subject(s)
Aldehyde Reductase , Diabetic Retinopathy , Lipase , Humans , Diabetic Retinopathy/genetics , Diabetic Retinopathy/epidemiology , Aldehyde Reductase/genetics , Lipase/genetics , Male , Prospective Studies , Female , France/epidemiology , Middle Aged , Aged , Polymorphism, Single NucleotideABSTRACT
DIABETES TEATED IN GENERAL PRACTICE. Blood glucose monitoring has been an integral part of diabetes treatment for many years, whether for type 1 diabetic patients on multiple daily injections of insulin, insulin pumps or artificial pancreas, and now for patients with type 2 diabetes, even without intnsified insulin therapy. Capillary blood glucose testing with glucose meters, developed in the 80s, has been largely replaced by continuous glucose monitoring with subcutaneous sensors, which since the early 2000s have revolutionized diabetes management, understanding and day-to-day monitoring, for patients and healthcare profressionals alike. Thanks to this continuous monitoring of circulating glucose levels, new performance indices have emerged and are now the subject of international consensus. Therapeutic objectives have been refined, with a shift from discontinuous, cross-sectional measurement of capillary glucose to continuous monitoring of interstitial glucose, enabling control, while also taking a safe look at time spent in areas of hypoglycemic risk and/or high hyperglycemia. The performance of these glucose sensors has been well established in terms of improving glycemic control and preventing certain complications associated with diabetes, justifying an extension of their reimbursement. These modern diabetes monitoring tools open up an impressive range of opportunities for personalized treatment, ultimately reducing the risk of hyperglycemia-related complications and improving patient comfort.
DIABÈTE TRAITÉ PAR INSULINE EN MÉDECINE GÉNÉRALE. La surveillance glycémique fait partie intégrante du traitement du diabète depuis de nombreuses années, que ce soit pour le patient diabétique de type 1 sous insulinothérapie en multi-injections, pompe ç insuline ou pancréas artificiel, ou désormais pour le patient atteint de diabète de type 2, même sans insulinothérapie intensifiée. La réalisation de la glycémie capillaire avec mesure du glucose par lecteur de glycémie, développée dans les années 1980, est désormais largement supplantée par les outils de mesure continue du glucose par capteur sous-cutané, lesquels ont révolutionné la prise en charge du diabète, sa compréhension, et son suivi au quotidien depuis le début des années 2000, pour les patients comme pour les professionnels de santé. Grâce à cette surveillance continue des taux circulants de glucose, de nouveaux indices de performance ont vu le jour et font maintenant l'objet de consensus internationaux. Se référant non plus à une mesure transversale et discontinue de la glycémie capillaire mais à une mesure continue du glucose interstitiel, les objectifs thérapeutiques se sont affinés, permettant d'évaluer avec précision le temps passé dans l'intervalle souhaité d'équilibre glycémique, tout en portant un regard de sécurité sur le temps passé dans des zones de risque hypoglycémique et/ou de forte hyperglycémie. Les performances de ces capteurs de glucose sont parfaitement établies en termes d'amélioration du contrôle glycémique et de la prévention de certaines complications liés au diabète, justifiant aujourd'hui un élargissement du champ de leur remboursement. Ces outils modernes de surveillance du diabète ouvrent un champ impressionnant d'opportunités de traitements personnalisés pour, à terme, une réduction du risque de complications liées à l'hyperglycémie et une amélioration du confort de vie du patient.
Subject(s)
Diabetes Mellitus, Type 1 , Diabetes Mellitus, Type 2 , General Practice , Hyperglycemia , Humans , Insulin/therapeutic use , Diabetes Mellitus, Type 2/drug therapy , Blood Glucose Self-Monitoring , Blood Glucose , Diabetes Mellitus, Type 1/drug therapy , Cross-Sectional Studies , Hypoglycemic Agents/therapeutic use , Hyperglycemia/drug therapyABSTRACT
BACKGROUND: The objective of this study was to evaluate the evolution of insulin resistance at 12 months after parathyroidectomy for primary hyperparathyroidism according to the preoperative severity of glucose metabolism abnormalities. METHODS: Observational study of patients who underwent parathyroidectomy between 2016 and 2021. Prediabetes and insulin resistance were defined as fasting glucose ≥1.00 g/L (American Diabetes Association) and homeostatic model assessment of insulin resistance >2.5, respectively. RESULTS: A total of 231 patients were included. Preoperatively, 75 patients (32%) had prediabetes, and 108 patients (47%) had insulin resistance. At 12 months postoperative, homeostatic model assessment of insulin resistance values significantly decreased in patients with prediabetes (-0.69; P = .04) and in patients with insulin resistance (-0.85; P < .001). In patients with prediabetes, 48/75 (64%) decreased their insulin resistance, including 15/48 (31%) with normalization of fasting glucose. In multivariate analysis, preoperative prediabetes (1.82, 1.03-3.21; P = .037) or preoperative homeostatic model assessment of insulin resistance >2.5 (3.90, 2.23-6.75; P < .001) remained independent predictors for insulin resistance reduction observed between preoperative and 12 months postoperative. CONCLUSION: Parathyroidectomy is more likely to reduce insulin resistance in patients with primary hyperparathyroidism and prediabetes or in patients with higher preoperative homeostatic model assessment of insulin resistance values. These data support the use of the preoperative prediabetes criterion in addition to the international workshop criteria for parathyroidectomy to better select patients for surgery.
Subject(s)
Hyperparathyroidism, Primary , Insulin Resistance , Prediabetic State , Humans , Prediabetic State/diagnosis , Blood Glucose , Hyperparathyroidism, Primary/surgery , Hyperparathyroidism, Primary/metabolism , Glucose , InsulinABSTRACT
AIMS: To present the final results of the TROPHIES study (The real-world observational prospective study of health outcomes with dulaglutide and liraglutide in patients with type 2 diabetes). MATERIALS AND METHODS: The prospective, real-world TROPHIES study included patients with type 2 diabetes initiating their first injectable glucose-lowering medication (GLM), dulaglutide or liraglutide, in France, Germany and Italy. The primary endpoint was the time spent on dulaglutide or liraglutide until a significant treatment change over 24 months. Other endpoints measured persistence with treatment, clinical outcomes (glycated haemoglobin [HbA1c] and weight) and treatment patterns. Kaplan-Meier estimates of time to first significant treatment change and persistence with treatment were generated. Propensity-score-based inverse probability of treatment weighting (IPTW) was used to adjust for baseline imbalances in the comparison between cohorts. RESULTS: The 286 of 1014 patients (28.2%) in the dulaglutide cohort and 448 of 991 patients (45.2%) in the liraglutide cohort had a significant treatment change over 24 months. By IPTW analysis, dulaglutide-initiating patients were less likely to have a significant treatment change (hazard ratio [HR] 0.54, 95% confidence interval [CI] 0.46-0.63) and more likely to be persistent with treatment (HR 0.69, 95% CI 0.56-0.86) over 24 months than liraglutide-initiating patients. Dulaglutide and liraglutide yielded similar HbA1c (-11.80 mmol/mol [1.08%] and -11.91 mmol/mol [1.09%]) and weight (-3.5 kg and -3.3 kg) reductions from baseline to 24 months. Few changes in patterns of treatment with other GLMs were observed in the two cohorts. CONCLUSIONS: Dulaglutide-initiating patients had a longer time spent without any significant treatment change and higher persistence than those initiating liraglutide. Treatment with either glucagon-like peptide-1 receptor agonist yielded similar and clinically meaningful reductions in HbA1c and body weight.
Subject(s)
Diabetes Mellitus, Type 2 , Humans , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/epidemiology , Glucagon-Like Peptides/therapeutic use , Glycated Hemoglobin , Hypoglycemic Agents/therapeutic use , Immunoglobulin Fc Fragments/therapeutic use , Liraglutide/therapeutic use , Outcome Assessment, Health Care , Prospective Studies , Recombinant Fusion Proteins/therapeutic useABSTRACT
AIM: To report health-related patient-reported outcomes (PROs) in people with type 2 diabetes (T2D) initiating their first injectable glucose-lowering medication (GLM) with two commonly prescribed glucagon-like peptide-1 receptor agonists (GLP-1RAs) from the prospective, observational TROPHIES study (The Real-World Observational Prospective Study of Health Outcomes with Dulaglutide and Liraglutide in Type 2 Diabetes Patients). MATERIALS AND METHODS: TROPHIES was a two-cohort, 24-month study conducted in France, Germany and Italy. Adults with a T2D diagnosis, naïve to injectable treatment for T2D and prescribed dulaglutide or liraglutide as their first injectable GLM, were eligible for inclusion. Study objectives included describing the following PROs associated with the treatment of T2D with GLP-1RAs: health-related quality of life; impact of weight on self-perception; life and work productivity; and patient satisfaction with treatment and injection device. Additional analyses formally compared PRO measures between the treatment cohorts. RESULTS: Overall, improvements from baseline in PRO scores were observed among people who started dulaglutide or liraglutide. A more pronounced trend of improvement was observed in the dulaglutide cohort for changes from baseline in treatment satisfaction and impact of weight on self-perception, supported by statistically significant differences between treatment cohorts in additional comparative analyses at 12, 18 and 24 months. More positive patient perceptions of the injection device were observed with dulaglutide than with liraglutide. CONCLUSIONS: Improvements in PROs observed in TROPHIES, which were more evident with dulaglutide than liraglutide, reflect a relevant clinical benefit. From the patients' perspective, satisfaction, and confidence in continuing treatment with GLP-1RAs is likely to contribute to long-term treatment persistence.
Subject(s)
Diabetes Mellitus, Type 2 , Adult , Humans , Diabetes Mellitus, Type 2/drug therapy , Glucagon-Like Peptide-1 Receptor/agonists , Glucagon-Like Peptides/therapeutic use , Hypoglycemic Agents/therapeutic use , Immunoglobulin Fc Fragments/therapeutic use , Liraglutide/therapeutic use , Outcome Assessment, Health Care , Patient Reported Outcome Measures , Prospective Studies , Quality of Life , Recombinant Fusion Proteins/therapeutic useABSTRACT
Due to their cardiovascular protective effect, glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 inhibitors (SGLT2is) represent breakthrough therapies for type 2 diabetes mellitus (T2DM). In this review article, we discuss the mechanistic and clinical synergies that make the combined use of GLP-1RAs and SGLT2is appealing in patients with T2DM. Overall, the presented cumulative evidence supports the benefits of GLP-1RA plus SGLT2i combination therapy on metabolic-cardiovascular-renal disease in patients with T2DM, with a low hypoglycemia risk. Accordingly, we encourage the adoption of GLP-1RA plus SGLT2i combination therapy in patients with T2DM and established atherosclerotic cardiovascular disease (ASCVD) or multiple risk factors for ASCVD (i.e., age ≥ 55 years, overweight/obesity, dyslipidemia, hypertension, current tobacco use, left ventricular hypertrophy, and/or proteinuria). Regarding renal effects, the evidence of SGLT2is in preventing kidney failure is more abundant than for GLP-1RAs, which showed a beneficial effect on albuminuria but not on hard kidney endpoints. Hence, in case of persistent albuminuria and/or uncontrolled metabolic risks (i.e., inadequate glycemic control, hypertension, overweight/obesity) on SGLT2i therapy, GLP-1RAs should be considered as the preferential add-on therapy in T2DM patients with chronic kidney disease. Despite the potential clinical benefits of GLP-1RA plus SGLT2i combination therapy in patients with T2DM, several factors may delay this combination to become a common practice soon, such as reimbursement and costs associated with polypharmacy. Altogether, when administering GLP-1RA plus SGLT2i combination therapy, it is important to adopt an individualized approach to therapy taking into account individual preferences, costs and coverage, toxicity profile, consideration of kidney function and glucose-lowering efficacy, desire for weight loss, and comorbidities.
Subject(s)
Cardiovascular Diseases , Diabetes Mellitus, Type 2 , Hypertension , Sodium-Glucose Transporter 2 Inhibitors , Humans , Middle Aged , Diabetes Mellitus, Type 2/diagnosis , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/complications , Hypoglycemic Agents/adverse effects , Glucagon-Like Peptide-1 Receptor/agonists , Sodium-Glucose Transporter 2 Inhibitors/adverse effects , Overweight , Albuminuria/drug therapy , Obesity/complications , Hypertension/drug therapy , Glucose , Sodium , Cardiovascular Diseases/prevention & controlABSTRACT
Background and Aims: Older people with type 2 diabetes (T2DM) on insulin are at increased risk of hypoglycemia and associated morbidity. Management of T2DM in older people must optimize glycemic control, while minimizing risks for hypoglycemia and diabetic ketoacidosis (DKA). In France, the FreeStyle Libre® (FSL) system has been reimbursed since June 2017 for T2DM on intensive insulin therapy. We assessed the impact of starting FSL on hospitalizations for acute diabetes events (ADEs) in people ≥65 years old, with T2DM on intensive insulin therapy. Materials and Methods: A retrospective study on the French Système National des Données de Santé (SNDS) claims database was conducted on people ≥65 years old with T2DM, treated with multiple daily injections (MDI) or insulin pump and starting FSL between August 1, 2017, to December 31, 2018. The analysis covered claims data for 12 months before, and up to 24 months after FSL initiation. Hospitalizations for severe hypoglycemia (SH), DKA, comas, and hyperglycemia were identified using ICD-10 codes. Results: We identified 38,312 people with T2DM ≥65 years old on intensive insulin therapy initiating FSL during the selection period. Hospitalizations for ADEs were observed in 1.6% of subjects in the 12 months before FSL initiation, compared to 1.05% after 12 months and 0.96% after 24 months, a -34% and -40% reduction, driven by fewer DKA admissions after 12 months and by fewer SH admissions at 24 months. Conclusions: These results indicate that FSL can reduce hospitalization for ADEs in this vulnerable older population of adults 65 years of age and older with T2DM on intensive insulin therapy, in whom optimal glycemic control must be achieved, while minimizing risk of hypoglycemia and other ADEs.
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Diabetes Mellitus, Type 2 , Diabetic Ketoacidosis , Hypoglycemia , Adult , Humans , Aged , Diabetes Mellitus, Type 2/drug therapy , Insulin , Hypoglycemic Agents , Retrospective Studies , Blood Glucose , Hypoglycemia/chemically induced , Hypoglycemia/epidemiology , Hypoglycemia/prevention & control , Insulin, Regular, Human , Diabetic Ketoacidosis/chemically induced , France/epidemiologyABSTRACT
OBJECTIVE: The adipogenic PPARG-encoded PPARγ nuclear receptor also displays essential placental functions. We evaluated the metabolic, reproductive, and perinatal features of patients with PPARG-related lipodystrophy. METHODS: Current and retrospective data were collected in patients referred to a National Rare Diseases Reference Centre. RESULTS: 26 patients from 15 unrelated families were studied (18 women, median age 43 years). They carried monoallelic PPARG variants except a homozygous patient with congenital generalized lipodystrophy. Among heterozygous patients aged 16 or more (n = 24), 92% had diabetes, 96% partial lipodystrophy (median age at diagnosis 24 and 37 years), 78% hypertriglyceridaemia, 71% liver steatosis, and 58% hypertension. The mean BMI was 26 ± 5.0â kg/m2. Women (n = 16) were frequently affected by acute pancreatitis (n = 6) and/or polycystic ovary syndrome (n = 12). Eleven women obtained one or several pregnancies, all complicated by diabetes (n = 8), hypertension (n = 4), and/or hypertriglyceridaemia (n = 10). We analysed perinatal data of patients according to the presence (n = 8) or absence (n = 9) of a maternal dysmetabolic environment. The median gestational age at birth was low in both groups (37 and 36 weeks of amenorrhea, respectively). As expected, the birth weight was higher in patients exposed to a foetal dysmetabolic environment of maternal origin. In contrast, 85.7% of non-exposed patients, in whom the variant is, or is very likely to be, paternally-inherited, were small for gestational age. CONCLUSIONS: Lipodystrophy-related PPARG variants induce early metabolic complications. Our results suggest that placental expression of PPARG pathogenic variants carried by affected foetuses could impair prenatal growth and parturition. This justifies careful pregnancy monitoring in affected families.
Subject(s)
Hypertension , Hypertriglyceridemia , Lipodystrophy , Pancreatitis , Infant, Newborn , Humans , Female , Pregnancy , Adult , PPAR gamma/genetics , Retrospective Studies , Acute Disease , Placenta , ParturitionABSTRACT
AIM: To investigate sleep apnoea prevalence, factors influencing severity, and associations between sleep apnoea severity and micro-/macrovascular complications in a large population of patients with type 1 diabetes. MATERIALS AND METHODS: This French multicentre prospective cohort study was conducted between July 2016 and June 2020. Adults with type 1 diabetes using an insulin pump were eligible. Home care provider nurses collected demographic and clinical data and set up oximetry to determine the oxygen desaturation index (ODI). No, mild-moderate and severe sleep apnoea were defined as ODI <15 events/h, 15 to <30 events/h and ≥30 events/h, respectively. Univariate and multivariate analyses were performed to identify factors associated with sleep apnoea, and associations between sleep apnoea severity and micro-/macrovascular complications were determined using logistic regression. RESULTS: Of 769 participants, 12.4% and 3.4% had mild-to-moderate or severe sleep apnoea, respectively. Factors significantly associated with sleep apnoea on multivariate analysis were age, sex, body mass index (BMI) and hypertension. After adjustment for age, sex and BMI, presence of severe sleep apnoea was significantly associated with macrovascular complications (odds ratio vs. no sleep apnoea: 3.96 [95% confidence interval 1.43-11.11]; P < 0.01), while mild-to-moderate sleep apnoea was significantly associated with presence of diabetic retinopathy (odds ratio 2.09 [95% confidence interval 1.10-3.74]; P < 0.01). CONCLUSION: Sleep apnoea is a significant comorbidity in patients with type 1 diabetes, especially with respect to diabetic complications. This highlights the need for sleep apnoea screening and management in these individuals.
Subject(s)
Diabetes Mellitus, Type 1 , Sleep Apnea, Obstructive , Adult , Humans , Diabetes Mellitus, Type 1/complications , Diabetes Mellitus, Type 1/epidemiology , Prospective Studies , Sleep Apnea, Obstructive/complications , Sleep Apnea, Obstructive/epidemiology , Sleep Apnea, Obstructive/diagnosis , Risk Factors , Prevalence , ComorbidityABSTRACT
Aims/Hypothesis: Initiation of insulin therapy in people with type 2 diabetes (T2DM) may be necessary to achieve glycemic targets but is associated with acute diabetes events (ADEs), including severe hypoglycemia (SH) or diabetic ketoacidosis (DKA). We assessed the impact of initiating FreeStyle Libre® system (FSL) on hospitalizations for ADEs in people with T2DM on basal insulin only regimen±noninsulin antidiabetic drugs. Materials and Methods: A retrospective study of the French national Système National des Données de Santé reimbursement claims database (≈66 million French people) identified people with T2DM on basal insulin therapy receiving a first reimbursement of FSL between August 1, 2017 and December 31, 2018. Claims data for the 12 months before, and up to 24 months after FSL initiation, were analyzed. Hospitalizations for ADEs were identified, using ICD-10 codes as main or related diagnosis, for: SH events; DKA events; comas; and hyperglycemia-related admissions. Results: A total of 5933 people with T2DM on basal insulin therapy initiated FSL during the selection period. Of the patients, 78.9% were on basal insulin and other hypoglycemic agents. Among the 5933 patients identified, 2.01% had at least one hospitalization for any ADE in the year before FSL initiation, compared to 0.75% (1 year) and 0.60% (2 years). Reductions in ADEs were driven by 75% fewer DKA admissions, with a 44% reduction in SH admissions. These patterns of reduced ADEs persisted after 2 years, with a further 43% reduction in DKA rates. Conclusions/Interpretation: This study emphasizes the value of the FSL system in reducing ADEs in people with T2DM in France not on intensive insulin therapy and initially treated with basal-only insulin therapy.
Subject(s)
Diabetes Mellitus, Type 2 , Diabetic Ketoacidosis , Hypoglycemia , Humans , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/diagnosis , Retrospective Studies , Blood Glucose , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use , Hypoglycemia/chemically induced , Hypoglycemia/epidemiology , Hypoglycemia/prevention & control , Diabetic Ketoacidosis/epidemiology , Diabetic Ketoacidosis/etiology , Diabetic Ketoacidosis/prevention & control , Hospitalization , Insulin, Regular, Human/therapeutic use , France/epidemiologyABSTRACT
Objective: The primary aim of this study was to identify predictive factors associated with onset of de-novo clinically significant pituitary insufficiencies following endoscopic endonasal surgery (EES) for pituitary adenomas. The secondary objective explored the predictive factors of surgical success. Methods: A retrospective analysis was conducted on 211 patients who underwent EES. Logistic regression models were employed for the primary and secondary objectives. Patients were stratified into specific groups based on surgical indications and prolactin levels for nuanced analysis. Results: Significant predictors for de-novo pituitary insufficiencies included male sex (OR 3.3, CI95% 1.3-8.1, p=0.01), immediate postoperative insufficiencies (OR 5.6, CI95% 2.8-11.1, p<0.001), and HYPRONOS criteria (OR 5.7, CI95% 1.6-20.9, p=0.008). For surgical success, preoperative insufficiencies (OR 0.7, CI95% 0.5-0.9, p=0.008), repeat surgeries (OR 0.1, CI95% 0-0.4, p=0.001), and gonadotroph or somatotroph adenomas were significant. Age and adenoma size were not predictive in multivariate analysis. Furthermore, we observed a "dip and recover" effect of prolactin after surgery and lower prolactin levels at follow-up (< 3 ng/ml) are correlated with more anterior pituitary insufficiencies than normoprolactinemic patients (p = 0.004). Conclusion: This study identifies key predictors for outcomes in pituitary surgery. Our research is the first to employ individualized success criteria for EES, challenging existing perceptions about the role of age and adenoma size. These findings open avenues for nuanced, individualized preoperative risk assessment and postoperative management.
Subject(s)
Adenoma , Hypopituitarism , Pituitary Neoplasms , Humans , Male , Pituitary Neoplasms/surgery , Pituitary Neoplasms/complications , Prognosis , Retrospective Studies , Prolactin , Treatment Outcome , Adenoma/surgery , Adenoma/complications , Hypopituitarism/complicationsABSTRACT
INTRODUCTION: The use of predictive low-glucose suspend (PLGS) sensor-augmented pumps has been shown to lead to a significant reduction in hypoglycemic episodes in patients with type 1 diabetes (T1D), but their effects on hyperglycemia exposure are heterogeneous. The aim of this study was to determine the settings of the Medtronic 640G system to obtain the optimal balance between occurrence of both hypoglycemia and hyperglycemia. METHODS: The hypo- and hyperglycemia area under the curve (AUC), as well as system settings [hypoglycemic threshold, mean insulin total daily dose (TDD), mean basal insulin percentage, and mean daily duration of PLGS] were collected between 2 and 12 times during 1 year in patients from four university hospital centers. Univariate/multivariate analyses and receiver operating characteristics (ROC) curves were performed to determine factors associated with hyper- and hypoglycemia AUC. RESULTS: A total of 864 observations were analyzed from 110 patients with T1D. Two preselected settings predictive of low hyperglycemia AUC were a basal insulin percentage < 52.0% [sensitivity (Se) = 0.66 and specificity (Sp) = 0.53] and a PLGS duration > 157.5 min/day (Se = 0.47 and Sp = 0.73). The preselected setting predictive of a low hypoglycemia AUC was a PLGS duration ≤ 174.4 min (Se = 0.83 and Sp = 0.51). Between-visit variation of PLGS and TDD was positively correlated (r = 0.61; p < 0.0001). CONCLUSION: The most important Medtronic 640G setting was the mean daily PLGS duration, where a value between 157.5 and 174.4 min/day was associated with the best reduction in both hypo- and hyperglycemia AUC. In this study, we showed that PLGS duration could be indirectly modified through total daily insulin dose adaptation. TRIAL REGISTRATION: This study is registered in clinicaltrials.gov (NCT03047486).
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AIMS: The 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 METHODS: TROPHIES 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. RESULTS: By 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. CONCLUSIONS: In 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.
Subject(s)
Diabetes Mellitus, Type 2 , Liraglutide , Humans , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/chemically induced , Prospective Studies , Glycated Hemoglobin , Drug Administration Schedule , Glucagon-Like Peptides , Immunoglobulin Fc Fragments/adverse effects , Recombinant Fusion Proteins/adverse effects , Hypoglycemic Agents , Glucagon-Like Peptide 1 , Outcome Assessment, Health Care , Glucagon-Like Peptide-1 Receptor/agonistsABSTRACT
Background: Support programs are provided to people with diabetes to help them manage their disease. However, adherence to and persistence in support programs are often low, making it difficult to demonstrate their effectiveness. Aim: To identify the determinants of patients' perceived interest in diabetes support programs because it may be a powerful determinant of effective participation in such programs. Patients and Methods: An online study conducted in April 2021 in metropolitan France on 600 people with diabetes recruited from a consumer panel. A 64-item psychosocial questionnaire including a question asking to evaluate the helpfulness of a support program was used. Univariate, multivariate, and multiple correspondence analyses were performed. Results: The existence of a typology, known as Unsafe/Safe, was discovered, in which patients with type 2 diabetes respond in two distinct ways. Type U (unsafe) patients, who believe that a support program would be helpful, are more likely to be nonadherent to their treatment, have high hemoglobin A1c levels, have at least one diabetic complication, lack information regarding their disease and treatment, rate the burden of their disease and impairment of their quality of life as high, worry about their future, and are pessimistic. Type S (safe) patients have the opposite characteristics. Type U patients can be dichotomized into two broad classes: one in which they lack information regarding disease and treatment and the other in which alterations in the quality of life and burden of the disease predominate. Insulin-treated patients give more importance to the lack of information, whereas noninsulin-treated patients complain primarily about the burden of the disease and impairment of quality of life. Conclusion: This study describes this new U/S typology, proposes a simple method based on a nine-item questionnaire to identify type U patients by calculating a Program Helpfulness Score described herein, and clarifies the nature of the intervention to be provided to them. This novel approach could be applied to other chronic diseases.
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AIM: Flash glucose monitoring provides a range of glucose metrics. In the current study, we aim to identify those that indicate that glycaemic targets can be consistently met and contrast the total (t-CV) and within-day coefficient of variation (wd-CV) to guide the assessment of glucose variability and hypoglycaemia exposure. METHODS: De-identified data from Flash readers were collected. The readers were sorted into 10 equally sized groups of scan frequency followed by quartiles of estimated A1c (eA1c). A similar grouping was performed for the total coefficient of variation (t-CV) and within-day coefficient of variation (wd-CV). In addition, analysis of the association of time below 54 mg/dl and glucose variability measured by t-CV and wd-CV was performed. RESULTS: The dataset included 1 002 946 readers. Readers sorted by 10 equal groups of scan rate and quartiles by eA1c, t-CV and wd-CV represented 25 074 readers per group. The association of lower eA1c with higher time in range and reduced time above range was clear. The correlation of eA1c quartiles and time below range was not consistent. An association between glucose variability and hypoglycaemia was found. Both wd-CV and t-CV were associated with time below range. For achieving the consensus target of <1% time below 54 mg/dl, the associated wd-CV and t-CV values were 33.5% and 39.5%, respectively. CONCLUSIONS: The type of CV reported by the different continuous glucose monitoring systems should be acknowledged. CV <36% might not be adequate to ensure low hypoglycaemia exposure. To our knowledge, the majority of continuous glucose monitoring reports the t-CV. Appropriate thresholds should be used to identify patients that would probably meet time below range targets (t-CV <40% or wd-CV <34%).
Subject(s)
Diabetes Mellitus, Type 1 , Hypoglycemia , Blood Glucose , Blood Glucose Self-Monitoring , Glucose , Glycated Hemoglobin , Humans , Hypoglycemia/chemically induced , Hypoglycemia/epidemiologyABSTRACT
Background: The RELIEF study has previously shown a fall in the rate of acute diabetes events (ADEs) in people living with type 1 diabetes (PwDT1) or people living with type 2 diabetes (PwDT2) in the 12 months after initiation of flash glucose monitoring (FLASH) in France. The 2-year follow-up has provided new insights on the frequency of ADEs, including severe hypoglycemia and diabetic ketoacidosis (DKA), during use of FLASH. Methods: The RELIEF study included 31,446 PwDT1 and 41,027 PwDT2 with a first delivery of FreeStyle Libre (FSL) between August 1 and December 31, 2017. Hospitalizations for DKA, severe hypoglycemia, diabetes-related coma, and hyperglycemia were recorded for the 12 months before and 24 months after FSL initiation. Persistence of the FSL system use was estimated through a Kaplan-Meier survival curve. Change in usual blood glucose monitoring was estimated through acquisition of blood glucose test strips. Results: In the 2 years after FSL initiation, hospitalizations for ADEs were reduced by 49% and by 48% in PwDT1 or PwDT2, respectively, driven by reductions in DKA. After 2 years, 88% of patients persisted with the system and estimated mean consumption of blood glucose test strips had fallen after 2 years by -82% and by -84% in type 1 diabetes mellitus and type 2 diabetes mellitus, respectively. Conclusion: Use of FSL consistently reduces the rates of hospitalization for ADEs, mainly DKA, 2 years after initiation, confirming this is not a transitory effect. Use of FSL also results in a clear and progressive drop in use of blood glucose test strips over the 2-year period.