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Aims: Research on hypoglycaemia and quality of life (QoL) has focused mostly on severe hypoglycaemia and psychological outcomes, with less known about other aspects of hypoglycaemia (e.g., self-treated episodes) and impacts on other QoL domains (e.g., relationships). Therefore, we examined the impact of all aspects of hypoglycaemia on QoL in adults with type 1 diabetes (T1DM)., Methods: Participants completed an online survey, including assessment of hypoglycaemia-specific QoL (using the 12-item Hypoglycaemia Impact Profile). Mann-Whitney U tests examined differences in hypoglycaemia-specific QoL by hypoglycaemia frequency, severity, and awareness. Hierarchical linear regression examined associations with QoL., Results: Participants were 1028 adults with T1DM (M ± SD age: 47 ± 15 years; diabetes duration: 27 ± 16 years). Severe and self-treated hypoglycaemia and impaired awareness negatively impacted on overall QoL and several QoL domains, including leisure activities, physical health, ability to keep fit/be active, sleep, emotional well-being, spontaneity, independence, work/studies, and dietary freedom. Diabetes distress was most strongly associated with hypoglycaemia-specific QoL, followed by generic emotional well-being, fear of hypoglycaemia, and confidence in managing hypoglycaemia. Hypoglycaemia frequency and awareness were no longer significantly associated with QoL once psychological factors were considered., Conclusions: Hypoglycaemia negatively impacts on several QoL domains. Psychological factors supersede the effect of hypoglycaemia frequency and awareness in accounting for this negative impact., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Aims: To develop an updated, more theoretically sound system for describing and assessing diabetes-related emotional distress (DD) in adults with type 2 diabetes (T2D)., Methods: Items were developed from qualitative interviews with 11 adults with T2D and 6 clinicians, then categorized as reflecting a core emotional experience of DD or a primary source of DD. Items were then administered to a national sample of TCOYD Registry participants. Data were analyzed using both exploratory (EFA) and confirmatory (CFA) factor analyses. Reliability (alpha) and construct validity also were assessed., Results: EFAs with 599 adults (258 insulin users, 341 non-insulin users) yielded a coherent DD Core scale and 7 DD Source scales (management demands, healthcare provider, hypoglycemia, long-term health, interpersonal issues, shame/stigma, healthcare access), which were confirmed by CFA. All alphas were >0.65. DD Core and DD Source scales were associated with criterion variables (all p < .001). Higher DD Core scores were linked to higher HbA 1c , BMI, more frequent severe hypoglycemia, and poorer self-management (all p < .001)., Conclusions: Good reliability and validity were found for this two-part T2DD Assessment System. It reflects a more contemporary and actionable approach to DD assessment that distinguishes between its key emotional dimension and its underlying contributors., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Aims: To investigate the relationship of unawareness of hypoglycemia with spectral analysis of heart rate variability (HRV) and clinical variables in type 1 diabetes (T1D) individuals., Methods: Participants with type 1 diabetes mellitus (type 1 diabetes) were prospectively assessed for hypoglycemia awareness using the Pedersen-Bjergaard method and were classified as normal hypoglycemia awareness, impaired hypoglycemia awareness and hypoglycemia unawareness. Indices of HRV in frequency domain were evaluated and Ewing tests were used for the diagnosis of cardiovascular autonomic neuropathy (CAN)., Results: Ninety-eight participants with T1D (mean age 26 years, average diabetes duration 13 years, and mean HbA1c 8.4%) were included in this study. The prevalence of hypoglycemia unawareness was 28%. No significant difference was observed on the prevalence of CAN among groups of different hypoglycemia awareness (p = 0.740). On regression analyses, abnormal results of HRV in frequency domain were not associated with unawareness of hypoglycemia. On univariable regression analysis, age, diabetes duration and estimated creatinine clearance were associated with unawareness of hypoglycemia., Conclusion: CAN as assessed by Ewing tests and spectral analysis of HRV is not associated with unawareness of hypoglycemia. There is association of age, diabetes duration and renal deficit with unawareness of hypoglycemia., Competing Interests: Declaration of competing interest We wish to confirm that there are known conflicts of interest associated with this publication and there has been no significant financial support for this work that could have influenced its outcome., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Hypoglycemia, a common complication of insulin therapy in patients with diabetes, is associated with increased hospital morbidity and mortality. Hypoglycemia may be underrecognized in hospitalized patients due to impaired counter regulation or reduced recognition. Beta blocker (BB) use may also affect hypoglycemia recognition., Aim: To characterize hypoglycemia unawareness and patient perceived hypoglycemia burden in hospitalized patients., Materials and Methods: Over a 2-month period, we prospectively identified non-critically ill cognitively intact hospitalized insulin-requiring patients who were undergoing bedside glucose monitoring. Participants were included if they reported any episode of hypoglycemia in the 30 days prior to admission and either had no BB use or were on stable BB for 90 days. Hypoglycemia unawareness was assessed using the Clarke score and burden of hypoglycemia was assessed with the (TRIM-HYPO) score., Results: Of the 46 participants, 20 were not taking a BB and 26 were taking a BB. Predictors of hypoglycemia during admission included glucose coefficient of variation and hospital length of stay. Nine participants (20%) had hypoglycemia unawareness (Clarke score ≥4). Participants with a history of coronary artery disease were less likely to have impaired awareness. Burden of hypoglycemia was associated with more hypoglycemia and longer hospital length of stay. There were no differences in measures of hypoglycemia unawareness or burden according to BB use., Conclusions: BB use was not related to hypoglycemia unawareness, or burden in hospitalized high risk patients. Hypoglycemia burden may identify patients at higher risk of hypoglycemia during admission., Competing Interests: Declaration of competing interest Kathleen Dungan, MD discloses research support from Sanofi Aventis, Novo Nordisk, Eli Lilly, consulting activities with Eli Lilly. Clarine Long has no competing interest to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Aims: In type 1 diabetes (T1D), treatment efficacy is limited by the unpredictability of blood glucose results and glycemic variability (GV). Fear of Hypoglycemia (FOH) remains a major brake for insulin treatment optimization. We aimed to assess the association of GV with FOH in participants with T1D in an observational cross-sectional study performed in 9 French Diabetes Centres (NCT02790060)., Methods: Participants were T1D for ≥5 years, aged 18-75 years, on stable insulin therapy for ≥3 months. The coefficient of variation (CV) of blood glucose and mean amplitude of glycemic excursions (MAGE) were used to assess GV from 7-point self-monitoring of blood glucose (SMBG). FOH was assessed using the validated French version of the Hypoglycemia Fear Survey-II (HFS-II) questionnaire., Results: Among a total of 570 recruited participants, 298 were suitable for analysis: 46% women, 58% on continuous subcutaneous insulin infusion [CSII], mean age 49 ± 16 years, HbA1c 7.5 ± 0.9%, HFS-II score 67 ± 18 and 12% with recent history of severe hypoglycemia during the previous 6 months, mean CV 39.8 ± 9.7% and MAGE 119 ± 42 mg/dL. CV and MAGE did not significantly correlate with HFS-II score (R = -0.05;P = 0.457 and R = 0.08;P = 0.170). Participants with severe hypoglycemia in the previous 6 months had higher HFS scores. Participants with higher HFS scores presented more hypoglycemias during follow-up., Conclusions: FOH as determined using the HFS-II questionnaire was not associated with 7-point SMBG variability in participants with T1D, but was associated with a positive history of severe hypoglycemia. Higher FOH was associated with higher frequency of hypoglycemia during follow-up., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Aims: To determine if impaired awareness of hypoglycemia in patients with type 1 diabetes persists over time and to assess if continuous glucose monitoring use was associated with improved awareness of hypoglycemia in our population., Methods: Thirty-six with type 1 diabetes and impaired awareness of hypoglycemia who participated in studies on impaired awareness of hypoglycemia between 2009 and 2015 were contacted to complete an online survey. The survey included the Cox/Clarke and Gold hypoglycemia questionnaires and questions about continuous glucose monitoring use., Results: 23 of 36 (63%) subjects contacted completed the survey. (12 M, 11 F; median age 51 years, median diabetes duration 34 years). One had had an islet cell transplant and was excluded. Persistent impaired awareness of hypoglycemia was found in 19/22 (86%) using the Cox questionnaire and 18/22 (82%) using the Gold questionnaire. Consistent use of continuous glucose monitoring over the last six months defined as using a device ≥75% of time over the last 6 months was reported by 67% (12/18) and 68% (13/19) of participants with persistent impaired awareness of hypoglycemia as measured by Gold and Cox; respectively. Nineteen of the 22 participants (86%) reported severe hypoglycemia over the last six months., Conclusion: Impaired awareness of hypoglycemia persisted in >80% of the subjects with type 1 diabetes we studied between 2009 and 2015. While the consistent use of continuous glucose monitoring among our participants was high; it did not translate into restoration of hypoglycemia awareness in this population. This real world data shows that severe hypoglycemia continues to be a frequent problem in this patient population., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Aims: To detect whether adults with type 1 diabetes mellitus (T1DM) have lower cognitive performance than healthy individuals and to detect risk factors for low cognitive performance., Methods: Twenty-six adults with T1DM and twenty-six healthy subjects matched for age, gender and educational level were compared for cognitive performance by a chronometric computerized test measuring visuo-spatial working memory (N-Back) and by two validated neuropsychological tests (Mini Mental State Examination, Animal Naming Test). Clinical data about diabetes duration, average daily insulin dosage, glycated haemoglobin, retinopathy, urine albumin-creatinine ratio, previous hypoglycaemic coma and awareness of hypoglycaemia were obtained from medical records. Basal pre-test glycemia and blood pressure were measured for each patient., Results: No differences were found between patients (n = 26) and healthy controls (n = 26) in neuropsychological tests. Within diabetic patients, those with impaired awareness of hypoglycaemia (n = 7) or history of coma in the recent 1-3 years (n = 5) had psychomotor slowing at the N-Back test (592 ± 35 vs. 452 ± 21 ms and 619 ± 40 vs. 462 ± 19 ms, respectively; both p < 0.01). The variables related to diabetic severity did not show a relationship with reaction times of the N-Back test., Conclusion: Psychomotor speed slowing is detectable in patients with T1DM who have a history of previous hypoglycaemic episodes or coma., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Aims: Islet cell transplantation can functionally cure type 1 diabetes complicated by hypoglycemia unawareness (HU), but requires immunosuppression. This study identified the lived experiences and risk/benefit considerations of patients pre-transplant., Methods: Content analysis identified themes from four open-ended questions pre-transplant in an islet transplant clinical trial. The sample included 23 (19 female) patients, with a mean age = 48.3 and diabetes duration = 29.3 years., Results: Lack of control due to diabetes and HU was the overarching theme pre-transplant. Four sub-themes were also identified: fear of hypoglycemia, diabetes-related complications, hopes/expectations after transplant, and transplant outcomes. Patients expressed fear of HU and long-term complications pre-transplant, and hoped islet transplant would improve diabetes management. Patients further emphasized anxiety over burdening others, and hopes of advancing research. In addition, other patients emphasized frustrations regarding the impact of HU on themselves, such as the inability to perform activities of daily living. Many patients were primarily worried about immunosuppressive side effects rather than islet transplant success., Conclusions: Patients viewed islet transplantation as a means to gain autonomy and control over their lives. They desired reduced anxiety associated with HU, despite concerns over immunosuppressive side-effects. These findings need confirmation, but may help to further improve patient education and patient-provider communication., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Aims: We aimed to re-assess the previously shown but recently disputed association between HbA1c and severe hypoglycemia., Methods: 52 Patients with T1D and IAH participated in an earlier reported randomized, crossover trial with two 16-week intervention periods comparing continuous glucose monitoring (CGM) with self-monitoring of blood glucose (SMBG). In this previous study, time spent in normoglycemia (the primary outcome), was improved by 9.6% (p<0.0001). We performed post-hoc analyses using a zero-inflated Poisson regression model to assess the relationship between severe hypoglycemia and HbA1c, glucose variability and duration of diabetes., Results: During SMBG use, HbA1c and the number of severe hypoglycemic events were negatively associated (OR 0.20 [95% CI 0.09 to 0.44]). During CGM use, this relationship showed an odds ratio of 0.65 (95% CI 0.42 to 1.01). There was no significant relationship between glucose variability or duration of diabetes and severe hypoglycemia., Conclusions: In patients with T1D and IAH, treated with standard SMBG, a negative association exists between HbA1c and the number of severe hypoglycemic events. Thus, reaching target HbA1c values still comes with a higher risk of severe hypoglycemia. CGM weakens this association, suggesting CGM enables patients to reach their target HbA1c more safely., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Aims: To identify the unique sources of diabetes distress (DD) for adults with type 1 diabetes (T1D)., Methods: Sources of DD were developed from qualitative interviews with 25 T1D adults and 10 diabetes health care providers. Survey items were then developed and analyzed using both exploratory (EFA) and confirmatory CFA) analyses on two patient samples. Construct validity was assessed by correlations with depressive symptoms (PHQ8), complications, HbA1C, BMI, and hypoglycemia worry scale (HWS). Scale cut-points were created using multiple regression., Results: An EFA with 305 U.S. participants yielded 7 coherent, reliable sources of distress that were replicated by a CFA with 109 Canadian participants: Powerlessness, Negative Social Perceptions, Physician Distress, Friend/Family Distress, Hypoglycemia Distress, Management Distress, Eating Distress. Prevalence of DD was high with 41.6% reporting at least moderate DD. Higher DD was reported for women, those with complications, poor glycemic control, younger age, without a partner, and non-White patients., Conclusions: We identified a profile of seven major sources of DD among T1D using a newly developed assessment instrument. The prevalence of DD is high and is related to glycemic control and several patient demographic and disease-related patient characteristics, arguing for a need to address DD in clinical care., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Diabetes mellitus is associated with significant morbidity and mortality derived from long-term microvascular and macrovascular complications of chronic hyperglycemia. The Diabetes Control and Complications Trial (DCCT) and the UK Prospective Diabetes Study (UKPDS) have clearly shown the benefits of intensive glycemic control for preventing or delaying the development and progression of long-term complications. However, intensive glycemic control, particularly with insulin therapy, is associated with an increased incidence of hypoglycemia, which is the major barrier to the implementation of intensive treatment from the physician's and patient's perspective. Avoiding the use of intensive treatment most often precludes optimal glycemic control. Some of the many underlying causes of hypoglycemia are defective and deficient counterregulatory responses, relative hyperinsulinization owing to a missed meal, excessive or unplanned exercise, erroneous insulin dosages, excessive insulinotropic effects of some oral secretagogues, and the failure of traditional insulin preparations to simulate the physiologic patterns of endogenous basal insulin secretion found in nondiabetic individuals. Additionally, patient involvement is critical to intensive glycemic control and should involve frequent self-monitoring of blood glucose (SMBG), adherence to treatment regimens, and knowledge of the interrelationship among physical activity, diet, and insulin. This review summarizes the current knowledge on hypoglycemia with a focus on the improvements in insulin therapy (i.e., the mealtime and basal insulin analogs) that may produce more normal physiologic insulin profiles with an attendant lower risk of hypoglycemia than that currently seen in clinical practice.

Hypoglycemic unawareness may be due to diminished adrenal and/or peripheral sympathochromaffin responses to hypoglycemia. To determine whether hypoglycemic symptom awareness is more closely related to adrenal or nonadrenal sympathetic activity, we studied the relationship between symptoms and the epinephrine, norepinephrine, and muscle sympathetic nerve activity (MSNA) responses to hypoglycemia in ten IDDM and ten control subjects. MSNA was measured continuously using microneurography during hyperinsulinemic (720 pmol m-2 min-1), glucose clamp with 60 min of euglycemia, 30 min of hypoglycemia, and 30 min of recovery. Subjects were asked to rate a series of symptoms every 10 min during the last 30 min of each period and were unaware of their plasma glucose concentration. MSNA increased significantly in both groups during insulin clamp (p < 0.05) and further increased during hypoglycemia (p < 0.01). Both epinephrine and norepinephrine levels significantly increased during hypoglycemia (p < 0.02). The increase in adrenergic symptom responses during hypoglycemia positively correlated with epinephrine (r = 0.75, p < 0.01), but not with MSNA in the control subjects. A similar near significant relationship for epinephrine was seen in IDDM subjects (r = 0.65, p = 0.056). No significant predictors were found for neuroglycopenic or cholinergic symptoms. Thus, the variation in hypoglycemic symptoms is not related to the MSNA response to hypoglycemia. Adrenergic symptom variation is due to differences in adrenal epinephrine secretion.