The multinational CRASH study found that substantive recommendations from health care providers were predictive of actions taken by people with diabetes during and after a severe hypoglycemic event, ...which highlights the importance of equipping people with actionable strategies to prevent and treat severe hypoglycemia should a severe hypoglycemic event arise.
Background: SURMOUNT-4 was a Phase 3 clinical trial evaluating the safety and efficacy of tirzepatide in adults living with obesity or overweight. The method of delivery for tirzepatide was via a ...weekly, single-use injection pen device. The aim of this qualitative interview study was to better understand the ease-of-use of the pen device used to administer the study medication. Methods: Exit interviews were conducted with a random sample of US-based participants who had completed their Week 88 primary endpoint and Week 92 safety follow-up visits in SURMOUNT-4. A semi-structured discussion guide was used to understand the participant experience of the study, including use of the single-use pen device. Participants also completed an Injection Device Experience Questionnaire (ID-EQ) during their interview. As of May 30, 2023, interviews are on-going; n = 79 have been completed. The intended total sample size is n = 90 interviews. Results: Most participants reported that the single-use pen device was easy to use, and this was reflected in their responses to the IDEQ item "Overall, the device is easy to use": 91% responded "Strongly Agree", and 9% responded "Agree." Participants commented that the device was convenient due to being pre-filled and packaged as an allin-one device, that administration was simple and required minimal steps to inject each dose, that using the device took very little time, and that the needle was small and caused little to no pain. The requirement for the drug (and therefore the device) to be kept refridgerated was the key limitation mentioned. Conclusions: Qualitative exit interview methodology was utilized to understand participants' overall experience during SURMOUNT-4. Participants in the SURMOUNT-4 clinical trial found the single-use injection pen device to be easy to use and convenient.
Background: People with young-onset obesity (diagnosed before age 25) may present with more cardiometabolic abnormalities and obesity-related complications and may be less likely to respond optimally ...to pharmacotherapy. Tirzepatide (TZP) is a once weekly GIP/GLP-1 receptor agonist approved for the treatment of type 2 diabetes (T2D) and under investigation for chronic weight management. We compared baseline characteristics and body weight (BW) change with TZP in participants with young vs later-onset obesity in SURMOUNT-1 which included adults with obesity/overweight with weight-related comorbidities without T2D. Methods: Post hoc analysis included participants (TZP/placebo pooled) with young (N = 946) vs later-onset obesity (N = 1560) with onset age derived from self-reported diagnosis date and birth date at study enrollment. Comparison of baseline characteristics was based on ANCOVA model and change from baseline in BW (placebo-adjusted, TZP pooled) at Week 72 based on MM RM. Results: Participants with young- versus later-onset obesity (mean age 37 vs 50 years) had longer duration of obesity (20 vs 11 years), higher BMI (40.4 vs 36.6 kg/m2), waist circumference (118 vs 112 cm), eGFR (106 vs 93 mL/min/1.73m2), alanine aminotransferase (28 vs 27 IU/L), and lower HbAlc (5.5 vs 5.6%), systolic blood pressure (121 vs 125 mmHg) and cholesterol (186 vs 196 mg/dL) at baseline, respectively (all p < 0.001). Participants with young-onset obesity achieved significantly greater BW loss with TZP than those with later-onset obesity (-20.8 vs -16.7 kg p < 0.001; -18.7 vs -16.8% p = 0.061). Conclusions: Participants with young-onset obesity demonstrated a mixed cardiometabolic risk profile, with some variables worse and some better than those with later-onset obesity. TZP led to substantial BW reduction irrespective of age of obesity diagnosis with greater BW loss in young- versus later-onset obesity. Future studies are warranted to better understand if early intervention in people with young-onset obesity may improve long-term outcomes.
Background: As new antiobesity treatments (AOTs) including injectables and surgery techniques emerge, there is an increasing need to understand expectations and preferences of people with obesity for ...AOT features that inform decision-making. The objective of this study was to explore weight management experiences, perceptions, and preferences of second-generation AOT and surgery features among people with obesity. Methods: Adults with a body mass index (BMI) ≥30 kg/m2 (≥27.5 if of Asian descent) participated in in-person focus group discussions (FGDs) on their experiences, perceptions, and expectations of AOTs. FGDs were recorded and transcripts were qualitatively coded using content analysis. Results: FGDs (5 in English n = 33 and 1 in Spanish n = 5) were conducted in the US. Participants were mean age 50.4 (±10.4) years old, 50% female, 58% White, 16% Black, and 21% Hispanic. Mean BMI was 38.5 (±6.9). Most had ≥1 obesity-related complication (hypertension 61%, osteoarthritis 32%, acid reflux 32%, type 2 diabetes 24%). Nearly all (89%) had previously attempted weight loss via lifestyle modification or oral prescription medications. Most important AOT benefits included amount of weight loss, improved ability to carry out daily activities, comorbidity risk reduction and increased energy. AOT-related concerns included side effects (26%), changes in appetite/diet (21%), surgery-related complications (18%) or anesthesia-related risks (18%), interactions with other medications (16%), vomiting (13%), diarrhea (11%), and nausea (11%). Risks to organs and weight regain also emerged as AOT concerns. Conclusions: When making hypothetical decisions, participants valued the amount of weight loss, time to noticeable weight loss, and comorbidity risk reduction. These were balanced by concerns around side effects, weight regain, and treatment duration. These results will inform a discrete choice experiment to elicit people with obesity's preferences for AOTs.
The Conversations and Reactions Around Severe Hypoglycemia cross-sectional study was conducted to better understand the severe hypoglycemia experiences in persons with diabetes (PWD) and their ...caregivers (CGs).
Adults with type 1 or type 2 diabetes and CGs were recruited in 8 countries; Canadian cohort data are reported in this study. Insulin-treated PWD who reported a severe hypoglycemic event within the past 3 years and CGs who care for PWD ≥4 years old and who met the criteria were eligible for the study. Participants completed an online survey about their experience with severe hypoglycemia, its treatment and actions during and after severe hypoglycemia.
Of the 324 respondents, 139 (43%) reported discussions about severe hypoglycemia with a health-care provider (HCP) at every visit. During the most recent severe hypoglycemic event, the most common actions taken included ingestion of oral carbohydrates and calling emergency medical services; glucagon was rarely used. Despite many respondents (67%) feeling scared because of the most recent severe hypoglycemic event, only 55% (51% with type 1 and 61% with type 2) discussed this event with an HCP. The event affected the mood/emotional status, physical activities and sleep of PWD and CGs.
Severe hypoglycemia impacts the emotional and physical status of PWD and CGs. Despite this, many respondents did not report discussions about the most recent severe hypoglycemic event with HCPs. Furthermore, <50% of the respondents reported discussions about severe hypoglycemia with HCPs at every visit. Purposeful communication about severe hypoglycemia can help fulfil Diabetes Canada guideline recommendations to review experiences with hypoglycemia among PWD at every visit.
L’étude transversale Conversations and Reactions Around Severe Hypoglycaemia (CRASH) a été réalisée pour mieux comprendre les expériences que vivent les personnes diabétiques (PD) et leurs soignants lors des épisodes d’hypoglycémie grave.
Les adultes atteints du diabète de type 1 ou de type 2 et les soignants ont été recrutés dans 8 pays. La présente étude révèle les données de la cohorte canadienne. Les PD traitées par insuline qui avaient rapporté un épisode d’hypoglycémie grave au cours des 3 dernières années et les soignants qui prenaient soin des PD âgées ≥ 4 ans et qui répondaient aux critères étaient admissibles à l’étude. Les participants ont rempli une enquête en ligne qui portait sur leur expérience en lien avec l’hypoglycémie grave, son traitement et les mesures prises durant et après l’hypoglycémie grave.
Parmi les 324 répondants, 139 (43 %) ont rapporté avoir discuté de l’hypoglycémie grave avec un prestataire de soins de santé (PSS) à chaque rendez-vous. Au cours de l’épisode le plus récent d’hypoglycémie grave, les mesures les plus fréquemment prises étaient les suivantes : l’ingestion de glucides par voie orale et l’appel des services médicaux d’urgence. Toutefois, le glucagon a rarement été utilisé. Malgré la crainte qu’avaient éprouvée plusieurs répondants (67 %) concernant le plus récent épisode d’hypoglycémie grave, seulement 55 % (51 % de ceux atteints du diabète de type 1 et 61 % de ceux atteints du diabète de type 2) ont parlé de cet épisode avec un PSS. L’épisode avait nui à l’humeur et à l’état émotionnel, aux activités physiques et au sommeil des PD et des soignants.
L’hypoglycémie grave a des répercussions sur l’état émotionnel et l’état physique des PD et des soignants. Malgré ces répercussions, plusieurs répondants n’ont pas rapporté avoir discuté de l’épisode d’hypoglycémie grave le plus récent avec les PSS. De plus, < 50 % des répondants ont rapporté avoir discuté de l’hypoglycémie grave avec les PSS à chaque rendez-vous. Des communications réfléchies sur l’hypoglycémie grave peuvent contribuer à donner suite aux recommandations de Diabète Canada afin d’examiner les expériences en lien avec l’hypoglycémie des PD à chaque rendez-vous.
The multinational CRASH study found that substantive recommendations from health care providers were predictive of actions taken by people with diabetes during and after a severe hypoglycemic event, ...which highlights the importance of equipping people with actionable strategies to prevent and treat severe hypoglycemia should a severe hypoglycemic event arise.
Treatments for severe hypoglycemia aim to restore blood glucose through successful administration of rescue therapy, and choosing the most effective and cost-effective option will improve outcomes ...for patients and may reduce costs for healthcare payers. The present analysis aimed to compare costs and use of medical services with nasal glucagon and injectable glucagon in people with type 1 and 2 diabetes in Canada when used to treat severe hypoglycemic events when impaired consciousness precludes treatment with oral carbohydrates using an economic model, based on differences in the frequency of successful administration of the two interventions.
A decision tree model was prepared in Microsoft Excel to project outcomes with nasal glucagon and injectable glucagon. The model structure reflected real-world decision-making and treatment outcomes, based on Canada-specific sources. The model captured the use of glucagon, emergency medical services (EMS), emergency room, inpatient stay, and follow-up care. Costs were accounted for in 2019 Canadian dollars (CAD).
Nasal glucagon was associated with reduced use of all medical services compared with injectable glucagon. EMS call outs were projected to be reduced by 45%, emergency room treatments by 52%, and inpatient stays by 13%. Use of nasal glucagon was associated with reduced direct, indirect, and combined costs of CAD 1,249, CAD 460, and CAD 1,709 per severe hypoglycemic event, respectively, due to avoided EMS call outs and hospital costs, resulting from a higher proportion of successful administrations.
When a patient with type 1 or type 2 diabetes is being treated for a severe hypoglycemic event when impaired consciousness precludes treatment with oral carbohydrate, use of nasal glucagon was projected to be dominant versus injectable glucagon in Canada reducing costs and use of medical services.
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