Severe Hypoglycemia Rates Are Highest among those with Suboptimal Reporting Behaviour—Results from the InHypo-DM Study

Abstract

Many patients fail to report severe hypoglycemia (SH) events to their healthcare provider (HCP). This limits the ability of HCPs to adjust treatment regimens and optimize glycemia. This study aimed to explore the independent association between patients’ disclosure of SH events to their HCP and self-reported rates of SH. Data were obtained from the InHypo-DM population-based study, Canada’s largest hypoglycemia-specific survey. To indicate SH disclosure, patients at risk for hypoglycemia rated how often they reported their SH events (using ADA definitions) to their HCP on a scale from Never to Always. Univariable analyses identified significant clinical or demographic confounders (p≤0.2). Based on the distribution of SH events, zero-inflated negative binomial (ZINB) regression was used to test the relationship between hypoglycemia disclosure and the retrospective incidence of SH events. A total of 552 people with T1DM (17%) or T2DM (83%) completed the InHypo-DM survey. Forty percent of respondents reported at least one or more SH events. The overall incidence rate of SH was 2.45 events/person-year. Thirty-four percent of respondents indicated that they always report SH events. Results of the ZINB model showed that the odds of experiencing any event was not significantly associated with disclosure behaviour (p=0.86). However, the rate of repeated events was almost double (IRR=1.9, 95% CI: 1.2 to 3.0, p=0.004) among individuals who under-reported their SH as compared to those who did not. These results persisted after adjusting for age, medication type, income, most recent HbA1c, and presence of comorbidities. This population-based study revealed a nearly two-fold higher rate of SH among those who under-report to their HCP. Thus, HCPs should be aware that patient reporting may not be a true reflection of SH events and make efforts to elicit accurate information regarding SH events from their patients, especially for those at risk for repeated SH. Disclosure A. Ratzki-Leewing: None. J.E. Black: None. S. Mequanint: None. N.H. Au: None. B.L. Ryan: None. S.M. Reichert: Other Relationship; Self; Novo Nordisk Inc., Sanofi, Abbott, AstraZeneca. Advisory Panel; Self; Servier. Speaker's Bureau; Self; Eli Lilly and Company. Other Relationship; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Speaker's Bureau; Self; Merck & Co., Inc., Janssen Pharmaceuticals, Inc.. J.B. Brown: None. S. Harris: Advisory Panel; Self; Novo Nordisk A/S, Sanofi, Merck, AstraZeneca, Amgen Inc., Lilly/Boehringer Ingelheim, Abbott, Janssen. Consultant; Self; Novo Nordisk A/S, Sanofi, Merck, AstraZeneca, Lilly/Boehringer Ingelheim, Abbott, Janssen. Research Support; Self; Novo Nordisk A/S, Sanofi, Merck, Abbott, AstraZeneca, Janssen. Other Relationship; Self; CIHR, CDA, The Lawson Foundation.

Development and validation of a real‐world model to predict 1‐year Level 3 (severe) hypoglycaemia risk in adults with diabetes (the iNPHORM study, United States)

“…55,56 Onymous versus anonymous self-report has been shown to underestimate SH frequency by 50-65%. 11,28 We further applied multiple backstops to attenuate information bias. Namely, we standardized questionnaires; incorporated validated measures; gathered comprehensive information to jog episodic recall; and gave participants up to 7 days to review and reflect on items before responding.…”

“…Web‐based, compared to postal‐ or telephone‐based, survey modes are generally more effective at eliciting accurate and honest reporting, 54 primarily because they demand little personally identifiable data 55,56 . Onymous versus anonymous self‐report has been shown to underestimate SH frequency by 50‐65% 11,28 . We further applied multiple backstops to attenuate information bias.…”

“…10 Modern hypoglycaemia management leans heavily on patient self-report, as so many events are treated outside the care system. 5,6 Nevertheless, deliberate SH non-disclosure by patients 11,12 and under-recognition by providers 13,14 can invalidate Level 3 event ascertainment during routine medical encounters. As a result, most events are liable to be undetected and unmanaged by clinicians, in spite of their preventability.…”

Family Members: The Forgotten Players in the Diabetes Care Team (The TALK-HYPO Study)

“…Indeed, PWD under-reporting of hypoglycemia (e.g. due to perceived consequences on the PWDs’ careers or driver’s licenses) has been identified as a major problem in clinical care [11, 12]. This is further demonstrated by higher observed rates of hypoglycemia in studies that utilize self-reported data as opposed to sourcing data from clinical trial settings [13, 14].…”

Severe (level 3) hypoglycaemia occurrence in a real‐world cohort of adults with type 1 or 2 diabetes mellitus (iNPHORM, United States)

“…Questionnaires are a preferred method for ascertaining level 3 hypoglycaemia epidemiology: (a) most events are not clinically documented; (b) the lack of a standard BG threshold for SH diminishes the relevance of glucometer data; and (c) deliberate patient non‐disclosure 14,15 and provider under‐recognition 16,17 occlude accurate event assessment at point‐of‐care. Research shows that online questionnaires, which demand little personally identifiable data, are more effective than postal or telephone modes at motivating participation and honest reporting 18,19 .…”