Hypoglycemia: New Definitions and Regulatory Implications

Ratner, Robert E.

doi:10.1089/dia.2018.0113

Cited by 39 publications

(33 citation statements)

References 34 publications

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“…The first step in the approach to IAS is confirming the diagnosis of hypoglycemia, which can be proved by the presence of the Whipple triad: symptoms or signs of hypoglycemia associated with low plasma glucose concentrations (≤ 70 mg/dL), 92,93 and resolution of those symptoms or signs after the plasma glucose concentration is raised by glucose administration. The documentation of the hypoglycemic episode is mandatory, since the nature of the hypoglycemiarelated symptoms is not pathognomonic.…”

Section: Diagnosismentioning

confidence: 99%

<p>Insulin Autoimmune Syndrome (Hirata Disease): A Comprehensive Review Fifty Years After Its First Description</p>

Cappellani¹,

Macchia²,

Falorni³

et al. 2020

DMSO

114

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Insulin autoimmune syndrome (IAS), also named Hirata's disease, is a rare condition characterized by hypoglycemic episodes due to the presence of high titers of insulin autoantibodies (IAA). IAS is a form of immune-mediated hypoglycemia, which develops when a triggering factor (ie, a medication or a viral infection) acts on an underlying predisposing genetic background. IAS pathogenesis involves the formation of insulin-IAA complexes that induce glycemic alterations with a double-phase mechanism: IAA prevent insulin to bind its receptor in the postprandial phase, possibly resulting in mild hyperglycemia; thereafter, insulin is released from the complexes irrespective of blood glucose concentrations, thus inducing hypoglycemia. The diagnosis of IAS is challenging, requiring a careful workup aimed at excluding other causes of hyperinsulinemic hypoglycemia. The gold standard for the definitive diagnosis is the finding of IAA in a blood sample. Because IAS is frequently a self-remitting disease, its management mostly consists of supportive measures, such as dietary modifications, aimed at preventing the development of hypoglycemia. Pharmacological therapies may occasionally be necessary for patients presenting with severe manifestations of IAS. Available therapies may include drugs that reduce pancreatic insulin secretion (somatostatin analogues and diazoxide, for instance) and immunosuppressive agents (glucocorticoids, azathioprine and rituximab). The purpose of this review is to provide a comprehensive analysis of the disease, by describing the burden of knowledge that has been obtained in the 50 years following its first description, took in 1970, and by highlighting the points that are still unclear in its pathogenesis and management.

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Section: Diagnosismentioning

confidence: 99%

<p>Insulin Autoimmune Syndrome (Hirata Disease): A Comprehensive Review Fifty Years After Its First Description</p>

Cappellani¹,

Macchia²,

Falorni³

et al. 2020

DMSO

114

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“…Hypoglycemia, or percent time 54 to <70 mg/dL (Level 1) or <54 mg/dL (Level 2), 19 did not change significantly from baseline to endpoint in the CSII group. Level 1 hypoglycemia increased significantly in the MDI group, but the change from baseline to endpoint was not significantly different between groups.…”

Section: Percent Tirmentioning

confidence: 85%

Glucose Variability and Time in Range in Type 2 Diabetes Treated with U-500R by Pump or Injection: CGM Findings from the VIVID Study

Blevins

Lane

Rodbard³

et al. 2021

Diabetes Technology & Therapeutics

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Background: The EValuating U-500R Infusion Versus Injection in Type 2 Diabetes Mellitus (VIVID) study compared two methods of U-500R insulin delivery, continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI), for 26 weeks in people with type 2 diabetes (T2D) requiring high doses of insulin. To assess glycemic variability (GV) and time in range (TIR), a subset of participants performed masked continuous glucose monitoring (CGM). Methods: VIVID participants were adults who had insulin requirements of >200 but £600 U/day and A1C 7.5% to 12%. Participants performed masked CGM for seven consecutive days on each of three occasions: before weeks 0 (baseline), 14, and 26. The primary objective was to compare GV between CSII and MDI groups, based on change from baseline of within-day standard deviation (SD w) of CGM glucose. Results: Of 54 participants enrolled, 41 with evaluable data were analyzed (17 and 24 in CSII and MDI groups, respectively). The CSII group had a significantly greater reduction from baseline in mean SD w of glucose (45.0 to 38.2 mg/dL [-8.1 mg/dL]) compared with the MDI group (47.0 to 45.8 [-0.4 mg/dL]; P = 0.047). TIR 70-180 mg/dL glucose increased significantly from baseline in the CSII group only, from 59.8% to 73.1% (change +12.9%, P < 0.05), but was not significantly different between groups. There were no significant between-group differences in the endpoint mean glucose or A1C. Conclusions: In the VIVID CGM substudy of U-500R in people with T2D requiring high doses of insulin, participants using CSII significantly reduced GV compared with MDI. CSII also significantly increased TIR with no difference between groups.

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“…The blood glucose summary (Figure 4 F) displays the average blood glucose value and the pooled SD (same values as in Table 1). The blood glucose values per range (Figure 4 G) display the number of registrations and their percentages per range (low, on target, or high), which are defined as per the standards [45,46]. This addresses requirement R8 (Table 1).…”

Section: Resultsmentioning

confidence: 99%

Design and Prestudy Assessment of a Dashboard for Presenting Self-Collected Health Data of Patients With Diabetes to Clinicians: Iterative Approach and Qualitative Case Study

Giordanengo

Årsand²,

Woldaregay

et al. 2019

JMIR Diabetes

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Background Introducing self-collected health data from patients with diabetes into consultation can be beneficial for both patients and clinicians. Such an initiative can allow patients to be more proactive in their disease management and clinicians to provide more tailored medical services. Optimally, electronic health record systems (EHRs) should be able to receive self-collected health data in a standard representation of medical data such as Fast Healthcare Interoperability Resources (FHIR), from patients systems like mobile health apps and display the data directly to their users—the clinicians. However, although Norwegian EHRs are working on implementing FHIR, no solution or graphical interface is available today to display self-collected health data. Objective The objective of this study was to design and assess a dashboard for displaying relevant self-collected health data from patients with diabetes to clinicians. Methods The design relied on an iterative participatory process involving workshops with patients, clinicians, and researchers to define which information should be available and how it should be displayed. The assessment is based on a case study, presenting an instance of the dashboard populated with data collected from one patient with diabetes type 1 (in-house researcher) face-to-face by 14 clinicians. We performed a qualitative analysis based on usability, functionality, and expectation by using responses to questionnaires that were distributed to the 14 clinicians at the end of the workshops and collected before the participants left. The qualitative assessment was guided by the Standards for Reporting Qualitative Research. Results We created a dashboard permitting clinicians to assess the reliability of self-collected health data, list all collected data including medical calculations, and highlight medical situations that need to be investigated to improve the situation of the patients. The dashboard uses a combination of tables, graphs, and other visual representations to display the relevant information. Clinicians think that this type of solution will be useful during consultations every day, especially for patients living in remote areas or those who are technologically interested. Conclusions Displaying self-collected health data during consultations is not enough for clinicians; the data reliability has to be assured and the relevant information needs to be extracted and displayed along with the data to ease the introduction during a medical encounter. The prestudy assessment showed that the system provides relevant information to meet clinicians’ need and that clinicians were eager to start using it during consultations. The system has been under testing in a medical trial since November 2018, and the first results of its assessment in a real-life situation are expected in the beginning of next year (2020).

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Hypoglycemia: New Definitions and Regulatory Implications

Cited by 39 publications

References 34 publications

<p>Insulin Autoimmune Syndrome (Hirata Disease): A Comprehensive Review Fifty Years After Its First Description</p>

<p>Insulin Autoimmune Syndrome (Hirata Disease): A Comprehensive Review Fifty Years After Its First Description</p>

Glucose Variability and Time in Range in Type 2 Diabetes Treated with U-500R by Pump or Injection: CGM Findings from the VIVID Study

Design and Prestudy Assessment of a Dashboard for Presenting Self-Collected Health Data of Patients With Diabetes to Clinicians: Iterative Approach and Qualitative Case Study

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