The Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation 303 (PREDICTIVE 303) Study (n = 5604) evaluated the effectiveness of insulin detemir, a long-acting basal insulin analogue, using a simplified patient self-adjusted dosing algorithm (303 Algorithm group) compared with standard-of-care physician-driven adjustments (Standard-of-care group) in a predominantly primary care setting, over a period of 6 months. Insulin detemir was to be started once-daily as add-on therapy to any other glucose-lowering regimens or as a replacement of prestudy basal insulin in patients with type 2 diabetes. Investigator sites rather than individual patients were randomized to either the 303 Algorithm group or the Standard-of-care group. Patients from the 303 Algorithm group sites were instructed to adjust their insulin detemir dose every 3 days based on the mean of three 'adjusted' fasting plasma glucose (aFPG) values (capillary blood glucose calibrated to equivalent plasma glucose values) using a simple algorithm: mean aFPG < 80 mg/dl (<4.4 mmol/l), reduce dose by 3 U; aFPG between 80 and 110 mg/dl (4.4-6.1 mmol/l), no change; and aFPG > 110 mg/dl (>1.1 mmol/l), increase dose by 3 U. The insulin detemir dose for patients in the Standard-of-care group was adjusted by the investigator according to the standard of care. Mean A1C decreased from 8.5% at baseline to 7.9% at 26 weeks for the 303 Algorithm group and from 8.5 to 8.0% for the Standard-of-care group (p = 0.0106 for difference in A1C reduction between the two groups). Mean FPG values decreased from 175 mg/dl (9.7 mmol/l) at baseline to 141 mg/dl (7.8 mmol/l) for the 303 Algorithm group and decreased from 174 mg/dl (9.7 mmol/l) to 152 mg/dl (8.4 mmol/l) for the Standard-of-care group (p < 0.0001 for difference in FPG reduction between the two groups). Mean body weight remained the same at 26 weeks in both groups (change from baseline 0.1 and -0.2 kg for the 303 Algorithm group and the Standard-of-care group respectively). At 26 weeks, 91% of the patients in the 303 Algorithm group and 85% of the patients in the Standard-of-care group remained on once-daily insulin detemir administration. The rates of overall hypoglycaemia (events/patient/year) decreased significantly from baseline in both groups [from 9.05 to 6.44 for the 303 Algorithm group (p = 0.0039) and from 9.53 to 4.95 for the Standard-of-care group (p < 0.0001)]. Major hypoglycaemic events were rare in both groups (0.26 events/patient/year for the 303 Algorithm group and 0.20 events/patient/year for the Standard-of-care group; p = 0.2395). In conclusion, patients in the 303 Algorithm group achieved comparable glycaemic control with higher rate of hypoglycaemia as compared with patients in the Standard-of-care group, possibly because of more aggressive insulin dose adjustments. The vast majority of the patients in both groups were effectively treated with once-daily insulin detemir therapy. The use of insulin detemir in this predominantly p...
Background This treat-to-target study compared the efficacy and safety of insulin detemir (IDet) and insulin glargine (IGla) in a basal-bolus (insulin aspart) regimen in type 2 diabetes.
ObjectiveTo determine the prevalence of obesity and its related comorbidities among patients being actively managed at a US academic medical centre, and to examine the frequency of a formal diagnosis of obesity, via International Classification of Diseases, Ninth Revision (ICD-9) documentation among patients with body mass index (BMI) ≥30 kg/m2.DesignThe electronic health record system at Cleveland Clinic was used to create a cross-sectional summary of actively managed patients meeting minimum primary care physician visit frequency requirements. Eligible patients were stratified by BMI categories, based on most recent weight and median of all recorded heights obtained on or before the index date of 1July 2015. Relationships between patient characteristics and BMI categories were tested.SettingA large US integrated health system.ResultsA total of 324 199 active patients with a recorded BMI were identified. There were 121 287 (37.4%) patients found to be overweight (BMI ≥25 and <29.9), 75 199 (23.2%) had BMI 30–34.9, 34 152 (10.5%) had BMI 35–39.9 and 25 137 (7.8%) had BMI ≥40. There was a higher prevalence of type 2 diabetes, pre-diabetes, hypertension and cardiovascular disease (P value<0.0001) within higher BMI compared with lower BMI categories. In patients with a BMI >30 (n=134 488), only 48% (64 056) had documentation of an obesity ICD-9 code. In those patients with a BMI >40, only 75% had an obesity ICD-9 code.ConclusionsThis cross-sectional summary from a large US integrated health system found that three out of every four patients had overweight or obesity based on BMI. Patients within higher BMI categories had a higher prevalence of comorbidities. Less than half of patients who were identified as having obesity according to BMI received a formal diagnosis via ICD-9 documentation. The disease of obesity is very prevalent yet underdiagnosed in our clinics. The under diagnosing of obesity may serve as an important barrier to treatment initiation.
IGF-based GH dosing is clinically feasible in both GHD and ISS patients, although GH dose requirements and auxological outcomes are distinct between these groups. This suggests a degree of both GH and IGF insensitivity in subjects with ISS that requires specific management strategies to optimize growth during GH therapy.
PurposeTo compare the prevalence of diabetes-related complications and comorbidities, clinical characteristics, glycemic control, and treatment patterns in patients with type 2 diabetes (T2D) within a large integrated healthcare system in 2008 vs 2013.MethodsAn electronic health record system was used to create a cross-sectional summary of all patients with T2D as on 1 July 2008 and 1 July 2013. Differences between the two data sets were assessed after adjusting for age, gender, race, and household income.ResultsIn 2008 and 2013, 24 493 and 41 582 patients with T2D were identified, respectively, of which the majority were male (52.3% and 50.1%) and Caucasian (79% and 75.2%). The mean ages (years) were 64.8 and 64.3. The percentages of patients across the defined A1C categories were 64.3 and 66.7 for <7%, 21.1 and 18.8 for 7–7.9%, 7.8 and 7.5 for 8–8.9%, and 6.8 and 7.0 for ≥9% in 2008 and 2013, respectively. The most prevalent T2D-related comorbidities were hypertension (82.5% and 87.2%) and cardiovascular disease (26.9% and 22.3%) in 2008 and 2013, respectively. Thiazolidinedione and sulfonylurea use decreased, whereas metformin and dipeptidyl peptidase-4 inhibitor use increased in the 5-year period.ConclusionsPatients with T2D are characterized by a high number of comorbidities. Over 85% of the patients had an A1C<8% within our integrated health delivery system in 2008 and 2013. In 2008 and 2013, metformin therapy was the most commonly utilized antidiabetic agent, and sulfonylureas were the most commonly utilized oral antidiabetic agent in combination with metformin. As integrated health systems assume greater shared financial risk in newer payment models, achieving glycemic targets (A1C) and the management of comorbidities will become ever-more important, for preventing diabetes-related complications, as well as to ensure reimbursement for the medical care that is rendered to patients with diabetes.
BackgroundIncreasing diabetes prevalence affects a substantial number of pregnant women in the United States. Our aims were to evaluate health outcomes, medical costs, risks and types of complications associated with diabetes in pregnancy for mothers and newborns.MethodsIn this retrospective claims analysis, patients were identified from the Truven Health MarketScan® database (2004–2011 inclusive). Participants were aged 18–45 years, with ascertainable diabetes status [Yes/No], date of birth event >2005 and continuous health plan enrolment ≥21 months before and 3 months after the birth.ResultsIn total, 839 792 pregnancies were identified, and 66 041 (7.86%) were associated with diabetes mellitus [type 1 (T1DM), 0.13%; type 2 (T2DM), 1.21%; gestational (GDM), 6.29%; and GDM progressing to T2DM (patients without prior diabetes who had a T2DM diagnosis after the birth event), 0.23%]. Relative risk (RR) of stillbirth (2.51), miscarriage (1.28) and Caesarean section (C-section) (1.77) was significantly greater with T2DM versus non-diabetes. Risk of C-section was also significantly greater for other diabetes types [RR 1.92 (T1DM); 1.37 (GDM); 1.63 (GDM progressing to T2DM)]. Risk of overall major congenital (RR ≥ 1.17), major congenital circulatory (RR ≥ 1.19) or major congenital heart (RR ≥ 1.18) complications was greater in newborns of mothers with diabetes versus without. Mothers with T2DM had significantly higher risk (RR ≥ 1.36) of anaemia, depression, hypertension, infection, migraine, or cardiac, obstetrical or respiratory complications than non-diabetes patients. Mean medical costs were higher with all diabetes types, particularly T1DM ($27 531), than non-diabetes ($14 355).ConclusionsComplications and costs of healthcare were greater with diabetes, highlighting the need to optimize diabetes management in pregnancy. © 2015 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons, Ltd.
Background Chronic Kidney Disease (CKD) is a major public health problem worldwide. There is limited literature on a model to project the number of people with CKD. This study projects the number of residents with CKD in Singapore by 2035 using a Markov model. Methods A Markov model with nine mutually exclusive health states was developed according to the clinical course of CKD, based on a discrete time interval of 1 year. The model simulated the transition of cohorts across different health states from 2007 to 2035 using prevalence, incidence, mortality, disease transition, and disease detection rates. Results From 2007 to 2035, the number of residents with CKD is projected to increase from 316,521 to 887,870 and the prevalence from 12.2% to 24.3%. Patients with CKD stages 1-2 constituted the largest proportion. The proportion of undiagnosed cases will decline from 72.1% to 56.4%, resulting from faster progression to higher CKD stages and its eventual detection. Conclusion By 2035, about one-quarter of the Singapore residents are expected to have CKD. National policies need to focus on primary disease prevention and early disease detection to avoid delayed treatment of CKD which eventually leads to end-stage renal disease.
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