Performance of a Glucose Meter with a Built-in Automated Bolus Calculator versus Manual Bolus Calculation in Insulin-Using Subjects

The New York Times published an article on April 5, 2014, titled "Even Small Medical Advances Can Mean Big Jumps in Bills" by Elizabeth Rosenthal, 1 claiming that diabetes technologies and therapies are overpriced, offer little value, and place an unjust burden on the US health care system. "That captive audience of Type 1 diabetics has spawned lines of high-priced gadgets and disposable accouterments, borrowing business models from technology companies like Apple." This controversial article failed to capture the benefits of technology not only in improving glycemic control as determined by hemoglobin A1c (A1c) but also in mitigating the frequency, severity, and cost of hypoglycemia. The article also did not address the increasing problem and resultant costs of hypoglycemia in patients with type 2 diabetes and how technology might be used to mitigate this as well. 2 In light of Rosenthal's article, it is important to objectively review the literature to answer the following questions: 1. What is the cost of hypoglycemia? 2. What is the evidence that technology can improve A1c and/or reduce the risk of hypoglycemia? 3. What are the limitations in using technology to accomplish this? 4. What is the cost-effectiveness of technology? 5661D STXXX10.

Section: Bolus Calculators (Bc)mentioning

confidence: 96%

The Benefits, Limitations, and Cost-Effectiveness of Advanced Technologies in the Management of Patients With Diabetes Mellitus

Vigersky

2015

“…Such calculators already exist for bolus insulin (primarily for insulin pumps or intensive care units), and several studies on such devices or programs have been published. [61][62][63][64][65][66][67][68][69][70] It is imaginable that the availability of basal insulin dose calculators that incorporate basal insulin titration algorithms-under the condition that the previously mentioned issues are taken into accountassists patients and physicians in real life and leads to substantial improvements of diabetes control. This improvement of diabetes control should be proven in controlled trials.…”

Section: What Are the Future Perspectives?mentioning

confidence: 99%

Common Standards of Basal Insulin Titration in T2DM

Arnolds

Heise

Flacke

et al. 2013

Type 2 diabetes mellitus has become a worldwide major health problem, and the number of people affected is steadily increasing. Thus, not all patients suffering from the disease can be treated by specialized diabetes centers or outpatient clinics, but by primary care physicians. The latter, however, might have time constraints and have to deal with many kinds of diseases or with multimorbid patients, so their focus is not so much on lowering high blood glucose values. Thus, the physicians, as well as the patients themselves, are often reluctant to initiate and adjust insulin therapy, although basal insulin therapy is considered the appropriate strategy after oral antidiabetic drug failure, according to the latest international guidelines. A substantial number of clinical studies have shown that insulin initiation and optimization can be managed successfully by using titration algorithms-even in cases where patients themselves are the drivers of insulin titration. Nevertheless, tools and strategies are needed to facilitate this process in the daily life of both primary health care professionals and patients with diabetes.

“…1 There is also an increasing body of evidence that bolus calculators may improve glycemic control and treatment satisfaction in patients who use these devices as intended.…”

Section: Potential Benefitsmentioning

confidence: 99%

Trends in FDA Regulation of Software to Control Insulin Dosing

Klonoff

Aimbe

2015

Insulin dosing software is increasingly residing on mobile medical devices such as blood glucose (BG) monitors, continuous glucose monitors, and handheld devices. Most of the available software products worldwide are not cleared by the US Food and Drug Administration (FDA). I expect that we will all be seeing even more of such software products in the next few years because of 3 trends: (1) the evidence for these products to provide benefits is accumulating, (2) the public's demand for mobile medical devices is growing, and (3) the mHealth cloud based software infrastructure is becoming more established. For this type of product to become accepted as mainstream medical products it will be necessary for them to receive regulatory clearance. The regulatory pathway at FDA is evolving. As the demand for assistance with insulin dosing grows, I expect that this type of software will become established as a widely used tool for managing insulinrequiring diabetes.