Design of a real-world, prospective, longitudinal, observational study to compare vortioxetine with other standard of care antidepressant treatments in patients with major depressive disorder: a PatientsLikeMe survey.

BACKGROUND: Major depressive disorder (MDD) is a recurrent psychiatric condition that presents challenges in responding to treatment and achieving long-term remission. To improve outcomes, a shared decision-making treatment approach with patient and healthcare practitioner (HCP) engagement is vital. PatientsLikeMe (PLM), a peer community of patients, provides information on MDD, symptoms, and treatment through forums and resources, helping patients stay engaged in their treatment journey. Data on PLM can be harnessed to gain insights into patient perspectives on MDD symptom management, medication switches, and treatment goals and measures. METHODS: This ongoing, decentralized, longitudinal, observational, prospective study is being conducted using the PLM platform in two parts, enrolling up to 500 patients with MDD in the United States aged ≥ 18 years to compare vortioxetine with other monotherapy antidepressants. The first qualitative component consists of a webinar and discussion forum with PLM community members with MDD, followed by a pilot for functionality testing to improve the study flow and questions in the quantitative survey. The quantitative component follows on the PLM platform, utilizing patient-reported assessments, over a 24-week period. Three surveys will be conducted at baseline and weeks 12 and 24 to collect data on patient global impression of improvement, depression severity, cognitive function, quality of life (QoL) and well-being, medication satisfaction, emotional blunting, symptoms of anhedonia and resilience, as well as goal attainment. Quantitative results will be compared between groups. The qualitative component is complete; patient recruitment is underway for the quantitative component, with results expected in late 2023. DISCUSSION: These results will help HCPs understand patient perspectives on the effectiveness of vortioxetine versus other monotherapy antidepressants in alleviating symptoms of MDD and improvements in QoL. Data from the PLM platform will support a patient goal-based treatment approach, as results can be shared by patients with their HCPs, providing them with insights on patient-centric goals, treatment management and adherence, as well as allowing them to observe changes in patient-related outcomes scores. Findings from the study will also help to optimize the PLM platform to build scalable solutions and connectivity within the community to better serve patients with MDD.

The association between depression symptom endorsement and glycemic outcomes in adolescents with type 1 diabetes.

OBJECTIVE: The prevalence of depression among adolescents with type 1 diabetes is estimated to be 2-3 times higher than in the general population. In adults with type 1 diabetes and depression, short-term outcomes are worse compared to individuals just diagnosed with type 1 diabetes. This study aims to determine if depressive symptom endorsement is associated with glycemic outcomes and short-term complications in adolescents with type 1 diabetes. RESEARCH DESIGN AND METHODS: Analysis was conducted using electronic medical records from the T1D Exchange Quality Improvement Collaborative. Adolescents with type 1 diabetes, aged 12-18, receiving treatment in a diabetes clinic who had been screened for depression with the PHQ-9 between 2016 and 2018 were eligible for inclusion. Individuals must have also had HbA1c data available from the day of depression screening and from 10 to 24 weeks after screening; the final sample size was 1714. RESULTS: Almost 30% of adolescents endorsed mild or greater (PHQ-9 ≥ 5) depressive symptoms. Endorsement of mild or greater depressive symptoms was associated with an 18% increased risk of an HbA1c ≥7.5% and a 42% increased risk of an HbA1c ≥9.0% on the day of screener administration. Depressive symptom endorsement was also associated with an 82% increased risk for DKA. CONCLUSIONS: This study suggests that depression symptoms are associated with an increased risk for elevated HbA1c and short-term complications. With the rising incidence of type 1 diabetes in youth, routine screening, and appropriate management of depression is needed.

"I've Had an Alarm Set for 3:00 a.m. for Decades": The Impact of Type 1 Diabetes on Sleep.

There is a dearth of research characterizing the impact on a caregiver's sleep when caring for a minor with type 1 diabetes. This study used focus groups of people with type 1 diabetes and caregivers of minors with type 1 diabetes to explore the experience of how diabetes affects sleep. The occurrence of both unanticipated and planned sleep disruptions led to the majority of participants reporting that their sleep was considerably affected by diabetes. Despite the improvement in blood glucose management that diabetes technology devices can provide, people with type 1 diabetes and their caregivers still report sleep disruption and sleep loss resulting from overnight diabetes management.

Patient perspectives on the use of half-unit insulin pens by people with type 1 diabetes: a cross-sectional observational study.

BACKGROUND: Half-unit pens offer the ability to dose insulin more precisely. Information about half-unit pen use and evidence of their benefits and drawbacks is limited. This study aims to characterize people with type 1 diabetes (T1D) who have used (current/former = EVER) vs. those who have never used half-unit pens (NEVER users) and to understand their perspective. METHODS: An observational cross-sectional online survey was administered through T1D Exchange's online patient community, myGlu.org, to understand the use of half-unit insulin pens. RESULTS: The 278 adult participants (156 EVER, 122 NEVER) had a mean age of 41.8 ± 12.7 years, body mass index of 26.0 ± 3.8 kg/m2, glycated hemoglobin of 6.3% ± 1.0%, and 55% were male. EVER users had T1D for a shorter duration than NEVER users (p < .001). EVER users were less likely to use continuous subcutaneous insulin infusion (p < .001) and more likely to start correcting high blood glucose at a lower level (p < .001) and low blood glucose at a higher level (p < .001). The highest ranked benefits of half-unit pen reported by its current users (N = 131) included prevention of hyperglycemia (40.5%), less anxiety or worry (23.7%), and prevention of hypoglycemia (16.8%). CONCLUSIONS: Half-unit insulin pen is perceived as an insulin device that may help people with T1D to avoid hypo- and hyperglycemic events and decrease their level of disease worry and anxiety. This study highlights the need for patients and health care providers to understand the benefits of half-unit pens while considering options for individualized diabetes management.

Factors associated with fear of hypoglycaemia among the T1D Exchange Glu population in a cross-sectional online survey.

OBJECTIVES: Fear of hypoglycaemia (FoH) has been associated with suboptimal diabetes management and health outcomes. This study investigated factors associated with behavioural and emotional aspects of FoH among adults living with type 1 diabetes (T1D) mellitus. DESIGN: Cross-sectional study. SETTING: Online survey hosted on T1D Exchange Glu, an online community for patients living with T1D mellitus. MEASURES: The Hypoglycaemia Fear Survey II-short form and the Hypoglycaemic Attitudes and Behaviour Scale were used to assess FoH. Multivariable regressions were performed on assessment scores. RESULTS: The study included 494 participants (mean±SD age 43.9±12.2 years, duration of T1D mellitus 16.6±16.8 years, self-reported glycosylated hemoglobin (HbA1c) 6.9%±0.8% (52±9 mmol/mol)), 63% men, 89% on insulin pump, 25% experienced a severe hypoglycaemic event in the last 6 months. Multivariable regression analyses showed higher anxiety, depression severity and diabetes distress were independently associated with FoH (all p<0.01). Longer diabetes duration was associated with lower FoH (p<0.01). Past experience with severe hypoglycaemia was associated with higher worry of hypoglycaemia (p<0.01) but not avoidance behaviour (ns). CONCLUSIONS: These results highlighted the multifaceted nature of FoH, which warrants further discussion between providers and patients to uncover drivers of and actions required to reduce FoH and improve patient care and outcomes.

Preeclampsia and other pregnancy outcomes in nulliparous women with type 1 diabetes: a retrospective survey.

Obstetric complications are more common in women with diabetes than in the general population. This study aimed to learn about the first pregnancy of women with type 1 diabetes from the perspective of women from T1D Exchange-Glu and the T1D Exchange Clinic Registry. Participants were ≥18, diagnosed with type 1 diabetes before conception, and either currently pregnant or had given birth in the preceding 10 years. The final sample size was 533 women. Women who planned pregnancy had significantly lower HbA1c (A1c) at conception. Women who had higher A1cs at conception were at a higher risk for cesarean birth, increased weight gain, hypoglycemia during pregnancy, and earlier onset of preeclampsia. Overall 29% of women developed preeclampsia in this population, over seven times the rate in the general population. This study helps to expand our knowledge of women with type 1 diabetes during the perinatal period. Planning pregnancy, expanding education and support, and preventing preeclampsia may help to improve pregnancy outcomes.

Novel Challenges in Aging with Type 1 Diabetes.

PURPOSE OF REVIEW: Due to treatment advancements, individuals with type 1 diabetes (T1D) are living longer, presenting a unique understudied population with advanced complex needs. This article is a review of the aging literature in T1D and identifies existing gaps while serving as a call to the research community. RECENT FINDINGS: Recent studies have identified an association between cognitive impairment and glycemic variability, as well as increased risk and frequency of hypoglycemia in older adults with T1D. However, limited research exists about additional physical and mental health conditions and barrier to successful treatment in this population. Older adults may experience both age- and diabetes-related barriers to diabetes management. Due to the scarcity of aging T1D research, current treatment guidelines for this age group are based on type 2 diabetes research. There is a critical need to further investigate the physical and mental effects of T1D and aging as well as public health policy; insurance challenges; and needs for support and interventions for older adults with T1D.

"I Live in Constant Fear of Highs," the Daily Impact of Type 1 Diabetes.

Limited research exists regarding the burdens associated with type 1 diabetes (T1D). The study's objective was to understand the impact of T1D from people with T1D and caregivers of minors with T1D. Six focus groups were conducted, with a total of 31 participants. Participants included people with T1D, ages 23 to 72 (n = 17) and caregivers ages 34 to 55 (n = 14). Participants were recruited from T1D Exchange Glu. People with T1D reported time spent managing diabetes had greatest impact, while caregivers reported financial and employment sacrifices as most impactful. Our findings provide insight into the real-world daily impact of diabetes.

Impact of Medicare Continuous Subcutaneous Insulin Infusion Policies in Patients With Type 1 Diabetes.

BACKGROUND: The Centers for Medicare and Medicaid Services (CMS) has numerous requirements for coverage of continuous subcutaneous insulin infusion (CSII; insulin pump). Due to recent improvements in diabetes treatment, people with type 1 diabetes are living longer, resulting in an increase in the number of individuals who are eligible for Medicare and are impacted by CMS policies regarding CSII. METHODS: Two hundred forty-one adults with type 1 diabetes who had been on CSII with CMS coverage for at least 6 months were surveyed. Median age was 67 years, mean A1c was 7.0%, 64% were women, 93% were white, and the median type 1 diabetes duration was 42 years. Participants reported median CSII use of 15 years and 82% were on CSII before starting CMS. RESULTS: Of those starting CSII while on CMS, challenges included cost of supplies (29%) or the insulin pump (24%). The majority (57.5%) reported issues with obtaining supplies, the most common problems being delays in release of supplies (29%), difficulty getting paperwork completed (23.5%), and seeing a health care provider every 90 days (18%). Participants reported changing their CSII behaviors because of supply delays (39%) including leaving site in place >3 days (64%), and reusing pump supplies (34%). Consequently, participants reported adverse outcomes including more erratic (48%) or higher (42%) blood glucose and pain or irritation at sites (34%). CONCLUSION: This study concluded that current CMS CSII policies promote adverse CSII behaviors and outcomes in type 1 diabetes and thus call for changes in the CMS CSII policies.

Misdiagnosis and Diabetic Ketoacidosis at Diagnosis of Type 1 Diabetes: Patient and Caregiver Perspectives.

IN BRIEF Diabetic ketoacidosis (DKA) is a life-threatening complication that frequently occurs at diagnosis of type 1 diabetes, occurs more commonly when a patient is misdiagnosed, is the leading cause of death in children with type 1 diabetes, and is associated with worse long-term outcomes. Our retrospective online survey found that 25% of all participants were misdiagnosed and that misdiagnosis was associated with an 18% increased risk for DKA compared to those correctly diagnosed. Adult providers should consider type 1 diabetes when diagnosing type 2 diabetes, and pediatric providers should rule out type 1 diabetes when a patient reports nonspecific viral symptoms.

Using patient reported outcomes in diabetes research and practice: Recommendations from a national workshop.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the American Diabetes Association (ADA) Co-Sponsored the workshop, Using Patient Reported Outcomes in Diabetes Research and Practice. The goal of the workshop was to identify PRO research priorities for those living with type 1 or type 2 diabetes, discuss considerations for use of disease specific versus generic measures, as well as outline research priorities to meet key end-user needs for assessing PROs for diabetes researchers, clinicians/hospital systems, patients/caregivers, and regulators. Here, we summarize the conclusions and recommendations from the workshop.

Use of Glucagon in Patients With Type 1 Diabetes.

IN BRIEF Glucagon is an invaluable tool for patients with type 1 diabetes who experience severe hypoglycemia, but little is known about the actual use of rescue glucagon in this patient population. This survey study found that patients with type 1 diabetes were not adequately prescribed glucagon or educated about the use of glucagon, and patients reported various administration issues in using it. These results strongly suggest the need for standards of practice to increase the prescribing of glucagon and the provision of initial and ongoing education about its use and administration and the development of a glucagon rescue device or a glucagon product that would eliminate the complexity of its current formulation and packaging.

Standardizing Clinically Meaningful Outcome Measures Beyond HbA1c for Type 1 Diabetes: A Consensus Report of the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange.

OBJECTIVE: To identify and define clinically meaningful type 1 diabetes outcomes beyond hemoglobin A1c (HbA1c) based upon a review of the evidence, consensus from clinical experts, and input from researchers, people with type 1 diabetes, and industry. Priority outcomes include hypoglycemia, hyperglycemia, time in range, diabetic ketoacidosis (DKA), and patient-reported outcomes (PROs). While priority outcomes for type 1 and type 2 diabetes may overlap, type 1 diabetes was the focus of this work. RESEARCH AND METHODS: A Steering Committee-comprising representatives from the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange-was the decision-making body for the Type 1 Diabetes Outcomes Program. Their work was informed by input from researchers, industry, and people with diabetes through Advisory Committees representing each stakeholder group. Stakeholder surveys were used to identify priority outcomes. The outcomes prioritized in the surveys were hypoglycemia, hyperglycemia, time in range, DKA, and PROs. To develop consensus on the definitions of these outcomes, the Steering Committee relied on published evidence, their clinical expertise, and feedback from the Advisory Committees. RESULTS: The Steering Committee developed definitions for hypoglycemia, hyperglycemia, time in range, and DKA in type 1 diabetes. The definitions reflect their assessment of the outcome's short- and long-term clinical impact on people with type 1 diabetes. Knowledge gaps to be addressed by future research were identified. The Steering Committee discussed PROs and concluded that further type 1 diabetes-specific development is needed. CONCLUSIONS: The Steering Committee recommends use of the defined clinically meaningful outcomes beyond HbA1c in the research, development, and evaluation of type 1 diabetes therapies.

Medical specialty camps for youth with diabetes.

Camps for children with medical conditions have been in existence for decades. With the advent of new medical technology and research advances, children with medical illnesses are living long lives with chronic conditions. Camp provides an ideal setting to help these youth manage and cope with their disease. Using camps for children who have diabetes as a model, this article reviews the history of medical specialty camps and the psychosocial and medical aspects of the disease that are unique to this population and describes the intentional programming and special considerations within this camping environment. The article concludes with a review of research and recent studies conducted at camps for youth who have diabetes that investigate the benefits of these specialized camping programs.