Dynamics in insulin requirements and treatment safety

Harper, Roy; Donnelly, Richard; Bi, Yixi; Bashan, Eran; Minhas, Rubin; Hodish, Israel

doi:10.1016/j.jdiacomp.2016.05.017

Cited by 13 publications

(21 citation statements)

References 25 publications

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“…In addition to increased effectiveness, frequent evaluations for insulin dose changes are necessary to avoid hypoglycemia. Over the course of a year, two-thirds of patients required a more than 20% decrease in their insulin requirements [ 30 ]. The period of decreased insulin doses lasted 10 weeks and the total insulin dose was decreased by 41%.…”

Section: Discussionmentioning

confidence: 99%

Effect of Remote Glucose Monitoring Utilizing Computerized Insulin Dose Adjustment Algorithms: A Pilot Project

Davidson

Davidson²

2019

Diabetes Ther

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Introduction Primary care physicians are often challenged to adjust insulin doses. To facilitate this process, we evaluated in a safety net clinic the work flow and glycemic effects of remote glucose monitoring utilizing Federal Drug Administration (FDA) cleared, Conformité Européenne (CE) registered software that contained computerized algorithms for insulin dose adjustments to help clinicians make dosing decisions for insulin-requiring patients. Methods Patients taking insulin for at least 6 months with HbA1 c levels of at least 8.0% measured glucose levels with a meter attached to their smartphones. Readings were automatically transmitted to a secure, Health Insurance Portability and Accountability Act (HIPAA)-approved server. Values were analyzed every 2–3 weeks and reports, including recommendations for insulin dose changes, were sent to a clinic nurse practitioner (NP) who modified or accepted the recommendations. A staff person contacted patients with the new doses determined by the NP. Results Insulin regimens included basal alone ( N = 11), basal/bolus ( N = 14), and self-mixed/split ( N = 3). Baseline HbA1 levels of 10.0% fell to 8.1% at 3 months ( N = 28) and 7.6% at 6 months ( N = 17) without any clinic visits for dose adjustments. There were 268 reports which allowed providers to see 268 other patients during these avoided clinic visits. The NP agreed with 82% of the recommendations. The total doses of insulin increased by 24%. No patient experienced severe hypoglycemia or visited an emergency department for hypoglycemia. Conclusion Remote glucose monitoring utilizing computerized insulin dose adjustment algorithms saved time for both providers and patients while effectively improving glycemia. Funding The Leonard M. Lipman Charitable Trust and Mellitus Health. Electronic supplementary material The online version of this article (10.1007/s13300-019-0565-y) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Effect of Remote Glucose Monitoring Utilizing Computerized Insulin Dose Adjustment Algorithms: A Pilot Project

Davidson

Davidson²

2019

Diabetes Ther

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“…14,[16][17][18] Dose titration, with frequent adjustments, has been shown to maximize treatment utility because metabolisms vary over time, beyond daily fluctuations in energy balance. 14,16,[19][20][21][22] However, the current structure of the health care system does not encourage (or in many cases permit) such frequent review of glucose data and corresponding timely insulin dosage modification. 19 In usual practice, insulin dose adjustments are done every 90 to 180 days during an outpatient clinic visit.…”

Section: Optimizing Insulin Dosingmentioning

confidence: 99%

“…16 To date, target HbA1c levels have only been consistently maintained in clinical trial settings with frequent insulin titration and monitoring. 21 This improvement lasted only as long as periodic insulin adjustments were made. According to Harper et al, the magnitude of intraindividual variability in insulin requirements is considerable and explains both bouts of hyperglycemia and hypoglycemia in insulin users.…”

Section: Optimizing Insulin Dosingmentioning

confidence: 99%

“…In addition, because the price of insulin is volume-based and there is no steady state for insulin dosage, the cost of insulin during the 9-month intervention may not reflect long-or short-term projected costs of insulin. 21 In addition to costs, two secondary outcomes of interest were also assessed: change in HbA1c and patient satisfaction. To evaluate if patients achieved reduction in HbA1c levels during the study period, we determined the difference between baseline HbA1c and the HbA1c measured at 90 days for each patient using a two-tailed student's t-test in Microsoft Excel.…”

Section: Main Outcome Measuresmentioning

confidence: 99%

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Economic Burden of Contraception Management in Spain

Ribes¹,

Poza

Campos

et al. 2018

JHEOR

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Background: A wide variety of contraceptive methods are available, some of them reimbursed by the Spanish National Health System (SNHS). However, the number of unintended pregnancies (UP) is still significant, leading to a high economic burden, mainly derived from non-adherence to and the incorrect use of contraceptive methods. Objectives: This study aims to estimate the economic burden associated with reversible contraception management in Spain, from the perspectives of both the SNHS and women, over a 5-year period. Methods: A survey was performed to identify contraception management in Spain based on the experience of a panel of six expert gynecologists. An economic model was conducted to quantify the current burden of contraception according to healthcare resources use over 5 years. The costs included in the analysis were diagnostic tests, initial and follow-up consultations, methods acquisition costs, and UP derived from therapy failure. Results: Reversible contraception costs in Spain amount to €12.5 billion over a 5–year period. Condoms and combined oral contraceptives (COC) account for 86.8% of the total cost and the other methods only 13.2%. There are differences in contraceptive use according to women’s age. Short-acting reversible contraceptives (SARC) such as COC, condom and vaginal ring, are most commonly used by younger women. However, SARC are correlated with the highest failure rate, resulting in over €7.2 billion cost, explained by the high number of UP. Long-acting reversible contraceptives (LARC), such as the levonorgestrel-releasing intrauterine system (LNG-IUS20), implant and copper intrauterine devices (IUD), are selected by women over 35 years of age due to user-independent compliance. SARC methods result in a higher cost per woman over 5 years: vaginal ring €2427.8, patch €2402.6, condom €2060.1 and COC €1895.1; while LARC methods are the most economic option per women: LNG-IUS20 €630.4, copper IUD €658.2, LNG-IUS12 €703.8, intramuscular injectable €907.8 and implant €940.5. Conclusions: LARC methods result in lower costs compared with SARC options from the perspectives of the SNHS and women, explained by user-independent compliance, preventing a significant number of UP and its elevated economic burden. An increased LARC methods use could avoid UP events, leading to significant cost-savings for the SNHS.

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“…Another challenge artificial pancreas systems face is the significant inter-day variability in insulin requirements that people with diabetes are subject to [24]. A solution to this problem is the inclusion of adaptive control mechanisms which automatically adjust the controller setting accordingly to the insulin requirements [25,26].…”

Section: Introductionmentioning

confidence: 99%

The Bio-inspired Artificial Pancreas for Type 1 Diabetes Control in the Home: System Architecture and Preliminary Results

Herrero

El-Sharkawy

Daniels

et al. 2019

J Diabetes Sci Technol

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Background: Artificial pancreas (AP) technology has been proven to improve glucose and patient-centered outcomes for people with type 1 diabetes (T1D). Several approaches to implement the AP have been described, clinically evaluated, and in one case, commercialized. However, none of these approaches has shown a clear superiority with respect to others. In addition, several challenges still need to be solved before achieving a fully automated AP that fulfills the users’ expectations. We have introduced the Bio-inspired Artificial Pancreas (BiAP), a hybrid adaptive closed-loop control system based on beta-cell physiology and implemented directly in hardware to provide an embedded low-power solution in a dedicated handheld device. In coordination with the closed-loop controller, the BiAP system incorporates a novel adaptive bolus calculator which aims at improving postprandial glycemic control. This paper focuses on the latest developments of the BiAP system for its utilization in the home environment. Methods: The hardware and software architectures of the BiAP system designed to be used in the home environment are described. Then, the clinical trial design proposed to evaluate the BiAP system in an ambulatory setting is introduced. Finally, preliminary results corresponding to two participants enrolled in the trial are presented. Results: Apart from minor technical issues, mainly due to wireless communications between devices, the BiAP system performed well (~88% of the time in closed-loop) during the clinical trials conducted so far. Preliminary results show that the BiAP system might achieve comparable glycemic outcomes to the existing AP systems (~73% time in target range 70-180 mg/dL). Conclusion: The BiAP system is a viable platform to conduct ambulatory clinical trials and a potential solution for people with T1D to control their glucose control in a home environment.

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Dynamics in insulin requirements and treatment safety

Abstract: Our findings may call attention to a major contributing factor to hypoglycemia among insulin users. In reality, insulin dosage is seldom adjusted and thus transient periods of decrease in insulin requirements and overtreatment are usually overlooked.

Cited by 13 publications

References 25 publications

Effect of Remote Glucose Monitoring Utilizing Computerized Insulin Dose Adjustment Algorithms: A Pilot Project

Effect of Remote Glucose Monitoring Utilizing Computerized Insulin Dose Adjustment Algorithms: A Pilot Project

Economic Burden of Contraception Management in Spain

The Bio-inspired Artificial Pancreas for Type 1 Diabetes Control in the Home: System Architecture and Preliminary Results

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