Dataset Information

Cost-effectiveness of Initiating an Insulin Pump in T1D Adults Using Continuous Glucose Monitoring Compared with Multiple Daily Insulin Injections: The DIAMOND Randomized Trial.

ABSTRACT: BACKGROUND:The economic impact of both continuous glucose monitoring (CGM) and insulin pumps (continuous subcutaneous insulin infusion [CSII]) in type 1 diabetes (T1D) have been evaluated separately. However, the cost-effectiveness of adding CSII to existing CGM users has not yet been assessed. OBJECTIVE:The aim of this study was to evaluate the societal cost-effectiveness of CSII versus continuing multiple daily injections (MDI) in adults with T1D already using CGM. METHODS:In the second phase of the DIAMOND trial, 75 adults using CGM were randomized to either CGM+CSII or CGM+MDI (control) and surveyed at baseline and 28 weeks. We performed within-trial and lifetime cost-effectiveness analyses (CEAs) and estimated lifetime costs and quality-adjusted life-years (QALYs) via a modified Sheffield T1D model. RESULTS:Within the trial, the CGM+CSII group had a significant reduction in quality of life from baseline (-0.02 ± 0.05 difference in difference [DiD]) compared with controls. Total per-person 28-week costs were $8,272 (CGM+CSII) versus $5,623 (CGM+MDI); the difference in costs was primarily attributable to pump use ($2,644). Pump users reduced insulin intake (-12.8 units DiD) but increased the use of daily number of test strips (+1.2 DiD). Pump users also increased time with glucose in range of 70 to 180 mg/dL but had a higher HbA1c (+0.13 DiD) and more nonsevere hypoglycemic events. In the lifetime CEA, CGM+CSII would increase total costs by $112,045 DiD, decrease QALYs by 0.71, and decrease life expectancy by 0.48 years. CONCLUSIONS:Based on this single trial, initiating an insulin pump in adults with T1D already using CGM was associated with higher costs and reduced quality of life. Additional evidence regarding the clinical effects of adopting combinations of new technologies from trials and real-world populations is needed to confirm these findings.

SUBMITTER: Wan W

PROVIDER: S-EPMC6226055 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Cost-effectiveness of Initiating an Insulin Pump in T1D Adults Using Continuous Glucose Monitoring Compared with Multiple Daily Insulin Injections: The DIAMOND Randomized Trial.

Wan Wen W Skandari M Reza MR Minc Alexa A Nathan Aviva G AG Zarei Parmida P Winn Aaron N AN O'Grady Michael M Huang Elbert S ES

Medical decision making : an international journal of the Society for Medical Decision Making 20181101 8

<h4>Background</h4>The economic impact of both continuous glucose monitoring (CGM) and insulin pumps (continuous subcutaneous insulin infusion [CSII]) in type 1 diabetes (T1D) have been evaluated separately. However, the cost-effectiveness of adding CSII to existing CGM users has not yet been assessed.<h4>Objective</h4>The aim of this study was to evaluate the societal cost-effectiveness of CSII versus continuing multiple daily injections (MDI) in adults with T1D already using CGM.<h4>Methods</h ...[more]

PMID: 30403576

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Project description:Aims/hypothesisWe aimed to compare diabetic retinopathy outcomes in people with type 1 diabetes following introduction of continuous subcutaneous insulin infusion (CSII) therapy with outcomes in people receiving continuing therapy with multiple daily insulin injections (MDI).MethodsThis is a retrospective cohort study using the Scottish Care Information - Diabetes database for retinal screening outcomes and HbA1c changes in 204 adults commenced on CSII therapy between 2013 and 2016, and 211 adults eligible for CSII during the same period but who continued on MDI therapy. Diabetic retinopathy progression (time to minimum one-grade worsening in diabetic retinopathy from baseline grading) was plotted for CSII and MDI cohorts using Kaplan-Meier curves, and outcomes were compared using multivariate Cox regression analysis adjusting for age, sex, baseline HbA1c, blood pressure, cholesterol, smoking status and socioeconomic quintile. Impact of baseline HbA1c and change in HbA1c on diabetic retinopathy progression was assessed within CSII and MDI cohorts.ResultsCSII participants were significantly younger, were from less socially deprived areas, and had lower HbA1c and higher diastolic BP at baseline. There was a larger reduction in HbA1c at 1 year in those on CSII vs MDI (-6 mmol/mol [-0.6%] vs -2 mmol/mol [-0.2%], p < 0.01). Diabetic retinopathy progression occurred in a smaller proportion of adults following commencement of CSII vs continued MDI therapy over mean 2.3 year follow-up (26.5% vs 18.6%, p = 0.0097). High baseline HbA1c (75 mmol/mol [9%]) was associated with diabetic retinopathy progression in the MDI group (p = 0.0049) but not the CSII group (p = 0.93). Change in HbA1c at follow-up, irrespective of baseline glycaemic status, did not significantly affect diabetic retinopathy progression in either group.Conclusions/interpretationCSII was associated with reduced diabetic retinopathy progression compared with continued MDI therapy, and may be protective against diabetic retinopathy progression for those with high baseline HbA1c. Progression of diabetic retinopathy over 3 years was not associated with a change in HbA1c.

Project description:BackgroundIntensive insulin therapy with continuous subcutaneous insulin infusion (CSII) devices or multiple daily injections (MDI) reduces the risk of long-term vascular complications of type I diabetes (TID). Both treatments are used routinely, but there is little evidence to demonstrate superiority of either treatment. If CSII treatment reduces the risk of long-term complications or is associated with an improved quality of life (QoL), the additional cost of this therapy may be compensated for by a reduction in long-term health expenditure. If there is no demonstrable difference between treatments, health-care resources may be better invested elsewhere. This study aims to address this gap in knowledge.Methods/designThis is a pragmatic, randomised controlled trial (RCT). Fifteen centres, selected to represent a population with a broad demographic, will recruit 316 patients, newly diagnosed with TID, aged between 7 months and 15 years. Exclusion criteria include additional pathologies or treatments likely to affect glycaemic control and a first-degree relative with TID. Randomisation to CSII or MDI is stratified for age, gender and recruiting centre. The randomised treatment starts within 15 days of diagnosis. Patients will be trained to adjust their insulin dose according to carbohydrate intake and blood glucose level. Study visits coincide with routine clinic appointments at 3, 6, 9 and 12 months when data relating to routine clinical assessments, adverse events and concomitant medications are collected. Health utilities questionnaires are completed at each visit and a diabetes-specific QoL questionnaire (PedsQL) at diagnosis, 6 and 12 months. The primary outcome is glycaemic control (HbA1c) at 12 months. Secondary outcome measures include QoL, insulin use, growth and weight gain, adverse events and a health economics appraisal.DiscussionThis is the first adequately powered RCT comparing CSII and MDI in a non-selected population, treated according to standard practice guidelines. It will produce data that are meaningful to individual patients and local and national policymakers.Trial registrationThe study was registered with the European Clinical Trials Database on 4 November 2010, reference 2010-023792-25.

Project description:ObjectiveTo investigate the long term effects of continuous subcutaneous insulin infusion (insulin pump therapy) on cardiovascular diseases and mortality in people with type 1 diabetes.DesignObservational study.SettingSwedish National Diabetes Register, Sweden 2005-12.Participants18,168 people with type 1 diabetes, 2441 using insulin pump therapy and 15,727 using multiple daily insulin injections.Main outcome measuresCox regression analysis was used to estimate hazard ratios for the outcomes, with stratification of propensity scores including clinical characteristics, risk factors for cardiovascular disease, treatments, and previous diseases.ResultsFollow-up was for a mean of 6.8 years until December 2012, with 114,135 person years. With multiple daily injections as reference, the adjusted hazard ratios for insulin pump treatment were significantly lower: 0.55 (95% confidence interval 0.36 to 0.83) for fatal coronary heart disease, 0.58 (0.40 to 0.85) for fatal cardiovascular disease (coronary heart disease or stroke), and 0.73 (0.58 to 0.92) for all cause mortality. Hazard ratios were lower, but not significantly so, for fatal or non-fatal coronary heart disease and fatal or non-fatal cardiovascular disease. Unadjusted absolute differences were 3.0 events of fatal coronary heart disease per 1000 person years; corresponding figures were 3.3 for fatal cardiovascular disease and 5.7 for all cause mortality. When lower body mass index and previous cardiovascular diseases were excluded, results of subgroup analyses were similar to the results from complete data. A sensitivity analysis of unmeasured confounders in all individuals showed that an unmeasured confounders with hazard ratio of 1.3 would have to be present in >80% of the individuals treated with multiple daily injections versus not presence in those treated with pump therapy to invalidate the significantly lower hazard ratios for fatal cardiovascular disease. Data on patient education and frequency of blood glucose monitoring were missing, which might have influenced the observed association.ConclusionAmong people with type 1 diabetes use of insulin pump therapy is associated with lower cardiovascular mortality than treatment with multiple daily insulin injections.

Project description:BackgroundThe use of continuous subcutaneous insulin infusion (CSII) therapy in pregnancies affected by pregestational diabetes mellitus (DM) has generated mixed outcome data worthy of further investigation. This systematic review and meta-analysis aims to evaluate clinical outcomes associated with CSII versus multiple daily injections (MDIs) in pregnant persons with pregestational DM.MethodsA predefined, systematic, librarian-assisted search of MEDLINE (PubMed), Embase, Cochrane Library, Scopus, ClinicalTrials.gov, and World Health Organization International Clinical Trial Registry Platform (published from 2010 to 2022) yielded 3003 studies describing pregnancy outcomes associated with CSII and/or MDI for pregestational DM. The primary exposure was mode of insulin administration, with cesarean delivery and neonatal hypoglycemia as the primary maternal and neonatal outcomes, respectively. Secondary outcomes included hypertensive disorders of pregnancy, first and third-trimester glycemic control, large-for-gestational age (LGA) neonate, preterm birth, neonatal intensive care unit admission, need for respiratory support, hyperbilirubinemia, 5-minute Apgar <7, shoulder dystocia, and perinatal mortality. We calculated pooled odds ratios (OR) with 95% confidence intervals (CI) using random-effects models.ResultsAmong 39 eligible studies, 39% of the 5518 pregnancies included were exposed to CSII. Odds of cesarean delivery were higher with CSII (20 studies: 63% vs 56%, odds ratio [OR] 1.3 [95% confidence interval (CI) 1.2-1.5]), but we did not identify a difference in the odds of neonatal hypoglycemia (23 studies: 31% vs 34%, OR 1.1 [95% CI 0.9-1.5]). Among secondary outcomes, only the odds of LGA (20 studies: 47% vs 38%, OR 1.4 [95% CI 1.2-1.6]) were higher in individuals using CSII versus MDI.ConclusionsUse of CSII (vs MDI) for pregestational DM in pregnancy is associated with higher odds of cesarean delivery and delivery of an LGA neonate. Further evaluation of how CSII use may influence neonatal size and delivery route is warranted.

Project description:BACKGROUND:The majority of therapies have generally targeted fasting glucose control, and current mealtime insulin therapies have longer time action profiles than that of endogenously secreted insulin. The primary purpose of this study was to assess both glucose time-in-range (TIR: 70-180?mg/dL) and postprandial glucose excursions (PPGE) in 1-4?h using a real-time continuous glucose monitor (CGM) with Technosphere insulin (TI) versus insulin aspart in patients with type 1 diabetes (T1DM) on multiple daily injections (MDI). RESEARCH DESIGN AND METHODS:This pilot, investigator-led, collaborative, open-label, multicenter, clinical research trial enrolled 60 patients with T1DM with HbA1c levels ?6.5% and ?10%. Individuals were randomized to treatment with titrated TI (n?=?26) or titrated insulin aspart (n?=?34), stratified by baseline HbA1c levels (?8% or >8%). All were required to wear a real-time CGM throughout the trial. All patients in the TI group were advised to take supplemental inhalations at 1 and 2?h after meals if indicated based on postprandial glucose (PPG) values. The coprimary outcomes were assessed both in the full intent-to-treat population and in those individuals randomized to TI who were compliant with supplemental doses ?90% of the time (n?=?15). The CGM data were analyzed using linear regression models. RESULTS:Overall, those treated with TI versus aspart achieved comparable TIR, but less time spent in hypoglycemia (<60 and <50?mg/dL, both P?<?0.05). In the TI-compliant group (n?=?15), TIR was significantly greater (62.5%?±?2.6% vs. 53.8%?±?1.7%, P?=?0.009) and time in hyperglycemia >180?mg/dL was lower (34.2%?±?2.7% vs. 41.0%?±?1.7%, P?=?0.045) as compared with the aspart group. PPG was also significantly lower in the TI cohort at 60 and 90?min postmeal, and PPGE were lower in the TI-compliant group as compared with the aspart group over 1-4-h postmeal (P?<?0.05). In addition, there was weight gain in the aspart group compared with weight loss in the TI group (P?=?0.006) despite higher prandial TI insulin dose. CONCLUSIONS:We conclude that using TI appropriately at mealtimes with supplemental dosing improves prandial glucose (TIR and 1-4?h) control without any increase in time in hypoglycemia or weight gain in patients with T1DM on MDI. The study results support a larger study using a treat-to-target design to confirm these findings. Clinical trial reg. no. NCT03143816, clinicaltrials.gov .

Dataset Information

Cost-effectiveness of Initiating an Insulin Pump in T1D Adults Using Continuous Glucose Monitoring Compared with Multiple Daily Insulin Injections: The DIAMOND Randomized Trial.

Publications

Cost-effectiveness of Initiating an Insulin Pump in T1D Adults Using Continuous Glucose Monitoring Compared with Multiple Daily Insulin Injections: The DIAMOND Randomized Trial.

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