A Glycemic Threshold Above Which the Improvement of ß-Cell Function and Glycemia in Response to Insulin Therapy Is Amplified in Early Type 2 Diabetes: The Reversal of Glucotoxicity.

OBJECTIVE: Alleviation of unrecognized glucotoxicity, with resultant recovery of ß-cell function, could amplify the glucose-lowering effect of pharmacotherapy and contribute to the variable therapeutic response observed among patients with type 2 diabetes (T2D). However, clinical evidence supporting this concept is lacking. Short-term intensive insulin therapy (IIT) can ameliorate glucotoxicity and improve ß-cell function in early T2D. Thus, for evidence of recovery of glucotoxicity-associated ß-cell dysfunction, we sought to determine whether there exists a baseline fasting glucose threshold above which the post-IIT improvement in both ß-cell function and glycemia is amplified. RESEARCH DESIGN AND METHODS: IIT (glargine, lispro) was administered for 3 weeks to 108 adults with T2D (mean duration 1.8 ± 1.4 years). Oral glucose tolerance tests before and after IIT enabled assessment of ß-cell function by Insulin Secretion-Sensitivity Index-2 and insulinogenic index/HOMA-insulin resistance. For each level of baseline fasting glycemia from 6.0 to 10.5 mmol/L, we modeled the difference in IIT-induced percentage change in ß-cell function between those at/above the indicated glucose level and those below it. RESULTS: The relationship between baseline fasting glucose and the differential change in ß-cell function was nonlinear. Instead, this relationship was best fit by a cubic regression model with inflection (amplification) at fasting glucose at 9.3 mmol/L. Moreover, baseline fasting glucose at 9.3 mmol/L also identified the inflection point at which nonlinear reductions in fasting glucose and 2-h glucose, respectively, were both amplified. CONCLUSIONS: The respective improvements in ß-cell function and glycemia in response to short-term IIT are amplified in those in whom baseline fasting glucose exceeds a defined threshold, consistent with reversal of glucotoxicity.

Evaluation of a unique and innovative diabetes care model in primary care in Ontario, Canada: protocol for a multiple-methods study with a convergent parallel design.

INTRODUCTION: The growth and complexity of diabetes are exceeding the capacity of family physicians, resulting in the demand for community-based, interprofessional, primary care-led transition clinics. The Primary Care Diabetes Support Programme (PCDSP) in London, Ontario, is an innovative approach to diabetes care for high-risk populations, such as medically or socially complex and unattached patients. In this study, we will employ a quadruple-aim approach to evaluate the health system impacts of the PCDSP. METHODS AND ANALYSIS: We will use multiple methods through a convergent parallel design in this project across five unique studies: a case study, a patient study, a provider study, a complications study and a cost-effectiveness study. The project will be conducted in a dedicated stand-alone clinic specialising in chronic disease management, specifically focusing on diabetes care. Participants will include clinic staff, administrators, family physicians, specialists and patients with type 1 or type 2 diabetes who received care at the clinic between 2011 and 2023. The project design will define the intervention, support replication at other sites or for other chronic diseases and address each of the quadruple aims and equity. Following the execution of the five individual studies, we will build a business case by integrating the results. Data will be analysed using both qualitative (content analysis and thematic analysis) and quantitative techniques (descriptive statistics and multiple logistic regression). ETHICS AND DISSEMINATION: We received approval from the research ethics boards at Western University (reference ID: 2023-1 21 766; 2023-1 22 326) and Lawson Health Research Institute (reference ID: R-23-202). A privacy review was completed by St. Joseph's Healthcare Corporation. The findings will be shared among PCDSP staff and patients, stakeholders, academic researchers and the public through stakeholder sessions, conferences, peer-reviewed publications, infographics, posters, media interviews, social media and online discussions. For the patient and provider study, all participants will be asked to provide consent and are free to withdraw from the study, without penalty, until the data are combined. Participants will not be identified in any report or presentation except in the case study, for which, given the number of PCDSP providers, we will seek explicit consent to identify them.

Use of once-daily oral semaglutide and associated clinical outcomes among adults with type 2 diabetes in routine clinical practice in Canada: A multicentre, prospective real-world study (PIONEER REAL Canada).

AIM: PIONEER REAL Canada examined real-world clinical outcomes associated with the use of once-daily oral semaglutide in adults with type 2 diabetes. MATERIALS AND METHODS: This was a 34- to 44-week, multicentre, prospective, open-label, non-interventional study in adults who were treatment-naive to injectable glucose-lowering medication and initiated oral semaglutide in routine clinical practice. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to the end of the study (EoS). Secondary endpoints assessed at EoS were change from baseline in body weight (BW); the proportion of participants reaching HbA1c levels <7% and the composite endpoints, HbA1c reduction ≥1% point with BW reduction ≥3% and ≥5%; and treatment satisfaction measured using Diabetes Treatment Satisfaction Questionnaires (DTSQ) status and change. Primary analyses were based on the in-study observation period. RESULTS: In total, 182 participants initiated oral semaglutide (mean age, 58.6 years; HbA1c, 8.0%; BW, 93.7 kg). The estimated changes (95% confidence interval) from baseline to EoS in HbA1c and BW were -1.09% points (-1.24, -0.94; p < .0001) and -7.17% (-8.24, -6.11; p < .0001), respectively. At EoS, 53.7% of participants had HbA1c levels <7%; 39.3% and 31.6% reached HbA1c reduction ≥1% point plus BW reduction ≥3% and ≥5%, respectively. Treatment satisfaction significantly increased (DTSQ status, +4.47 points; DTSQ change, 11.83 points; both p < .0001). At EoS, 75.3% of participants remained on oral semaglutide (55.5% received oral semaglutide 14 mg). No new safety signals were identified for oral semaglutide. CONCLUSIONS: In PIONEER REAL Canada, participants treated with oral semaglutide in routine clinical practice experienced clinically relevant reductions in HbA1c and BW and increased treatment satisfaction.

Examining a Remote Group-Based Type 2 Diabetes Self-Management Education Program in the COVID-19 Era Using the ORBIT Model: Small 6-Week Feasibility Study.

BACKGROUND: To date, most group-based diabetes self-management education (DSME) programs for type 2 diabetes (T2D) have been delivered in person. The rapid transition to remote care at the outset of the COVID-19 pandemic presented opportunities to test, evaluate, and iterate a new remote DSME program. OBJECTIVE: We aim to refine the delivery and evaluation of a multicomponent remote DSME program for adults living with T2D by examining several feasibility outcomes. METHODS: We recruited a convenience sample of patients from a London, Canada, outpatient diabetes clinic (serving high-risk, low-income adults) to participate in a 6-week, single cohort feasibility study from November 2020 to March 2021. This small ORBIT phase 1b feasibility study represents the first in a planned series guided by the ORBIT model for developing behavioral interventions for chronic diseases (phase 1: design; phase 2: preliminary testing; phase 3: efficacy; and phase 4: effectiveness). The feasibility of delivering and evaluating a remote DSME program, including (1) live video education classes, (2) individualized physical activity (PA) prescription and counseling, and (3) intermittently scanned continuous glucose and wearable PA monitoring, was assessed. Feasibility outcomes included recruitment and retention rates, program adherence, and acceptability (ie, technology issues and exit survey feedback). PA was assessed with Fitbit Inspire 2 (Fitbit Inc) and estimated glycated hemoglobin (HbA1c) using the FreeStyle Libre (Abbot). Given the small study sample, group- and individual-level data are reported descriptively. RESULTS: A total of 10 adults living with T2D were recruited (female 60%; age 49.9, SD 14.3 years; estimated HbA1c 6.2%, SD 0.5%). Recruitment and retention rates were 29% and 80%, respectively. Participants attended 83% (25/30) and 93% (37/40) of education classes and PA counseling phone calls, respectively. There were 3.2 (SD 2.6) technology issues reported per person, most of which were related to study data transfer. Exit survey responses suggest most participants (8/9, 89%) were "satisfied" with the program. Recognizing the small sample size and the fact that no inferential statistics were conducted, the mean (SD) for the weekly daily step count and estimated HbA1c are provided for illustrative purposes. Participants accumulated 7103 (SD 2900) and 7515 (SD 3169) steps per day at baseline and week 6, respectively. The estimated HbA1c was 6.2% (SD 0.5%) and 6.2% (SD 0.6%) at baseline and week 6, respectively. CONCLUSIONS: This ORBIT phase 1b study served to refine the delivery (eg, automatic study data upload process recommended to reduce participant burden) and evaluation (eg, purposeful sampling of participants with baseline HbA1c >8% recommended to address selection bias) of a remote DSME program. Preliminary proof-of-concept testing (ORBIT phase 2) incorporating some of these learnings is now warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT04498819; https://clinicaltrials.gov/study/NCT04498819.

Determinants of sustained stabilization of beta-cell function following short-term insulin therapy in type 2 diabetes.

In early type 2 diabetes, the strategy of "induction" with short-term intensive insulin therapy followed by "maintenance" with metformin can stabilize pancreatic beta-cell function in some patients but not others. We thus sought to elucidate determinants of sustained stabilization of beta-cell function. In this secondary analysis of ClinicalTrials.Gov NCT02192424, adults with ≤5-years diabetes duration were randomized to 3-weeks induction insulin therapy (glargine/lispro) followed by metformin maintenance either with or without intermittent 2-week courses of insulin every 3-months for 2-years. Sustained stabilization (higher beta-cell function at 2-years than at baseline) was achieved in 55 of 99 participants. Independent predictors of sustained stabilization were the change in beta-cell function during induction and changes in hepatic insulin resistance and alanine aminotransferase during maintenance. Thus, initial reversibility of beta-cell dysfunction during induction and subsequent preservation of hepatic insulin sensitivity during maintenance are associated with sustained stabilization of beta-cell function following short-term insulin and metformin.ClinicalTrials.Gov NCT02192424.

Responding to vulnerable patients with multimorbidity: an interprofessional team approach.

BACKGROUND: People with multimorbidity, who may be more vulnerable to certain social determinants of health, often require care by an interprofessional primary healthcare (PHC) team that can tailor their approach to address the multiple and complex needs of this population. This paper describes how the needs of vulnerable patients experiencing multimorbidity are identified and provided care by innovative interprofessional PHC teams during an innovative one-hour consultation, outside of usual care. METHODS: This was a descriptive qualitative study. Forty-eight interviews were conducted with 20 allied healthcare professionals: (e.g., social work, pharmacy); 19 physicians (e.g., psychiatry, internal medicine, family medicine); and 9 decision makers. The thematic analysis was iterative using an individual and team approach to identify the main themes and exemplar quotations for illustration. RESULTS: Participants described patients with multimorbidity who were vulnerable as those experiencing major challenges accessing and navigating the healthcare system. Mental health issues were a major contributor to being vulnerable and often linked to common social determinants of health. Cultural factors were identified as potentially causing patients to be vulnerable. Participants articulated how the collaborative nature of the team generated new ideas and facilitated creative recommendations designed to meet the specific needs of each patient. CONCLUSIONS: This one-time consultation went beyond the assessment of a patient's multimorbidity by including a psycho-social-contextual understanding of vulnerability within the healthcare system. Findings may have important clinical and policy implications in the adoption and implementation of this approach and further assist vulnerable patients with multimorbidity in having their complex needs addressed.

Real-World Incidence and Risk Factors for Daytime and Nocturnal Non-Severe Hypoglycemia in Adults With Type 2 Diabetes Mellitus on Insulin and/or Secretagogues (InHypo-DM Study, Canada).

BACKGROUND: The aim of this study was to estimate the real-world incidence of self-reported non-severe hypoglycemia (NSH) and its related sociodemographic and clinical risk factors in a general population of Canadian adults with type 2 diabetes mellitus (T2DM) taking insulin and/or secretagogues. METHODS: Data for this study were obtained from the InHypo-DM Study. Self-reported data on the frequency of NSH (past 30 days) as well as sociodemographic and clinical characteristics were collected through an online questionnaire. Risk factors for any, daytime and nocturnal NSH were identified using multivariable negative binomial regression with backward selection. RESULTS: Among 432 adults with T2DM (43.8% female, mean age of 53.1 years), 53.9% (95% confidence interval [CI], 49.2% to 58.6%) reported ≥1 event of any (i.e. daytime or nocturnal) NSH in the past 30 days. The 30-day incidence rate of any NSH was 2.3 events per 30 person-days (95% CI, 2.1 to 2.4). Risk factors associated with the increased rate of any NSH were younger age, lower annual household income, being employed, longer duration of diabetes, higher glycated hemoglobin and presence of comorbidity. Risk factors were generally similar for daytime NSH (except for the exclusion of diabetes duration and addition of diabetes medication type) and nocturnal NSH (except for the exclusion of being employed). CONCLUSIONS: This is the largest Canadian investigation to estimate the real-world frequency and distribution of self-reported NSH in T2DM. Events were alarmingly frequent and recurrent. Numerous sociodemographic and clinical risk factors were elucidated. These results highlight the importance of identifying high-risk individuals to minimize future occurrences of hypoglycemia.

Health Care Providers' Emotional Responses to Their Patients' Hypoglycemic Events: Qualitative Findings From the InHypo-DM Study, Canada.

OBJECTIVE: Hypoglycemia can cause psychological distress in people with diabetes; however, less is understood about the emotional impact of hypoglycemia on their health care providers (HCPs). This article focuses on the experiences and emotions of HCPs caring for patients with diabetes. METHODS: This was a descriptive qualitative study from the InHypo-DM research program. Purposive sampling was used to recruit 20 HCPs from a variety of professions for 30- to 45-minute semi-structured interviews. An iterative analysis was conducted to identify the overarching themes. RESULTS: Three overarching themes encompassed the responses of participants when their patients experienced hypoglycemia. The first was a sense of professional responsibility, as participants felt they must have failed or inadequately fulfilled their professional duties. The second was a more personal range of emotions such as sadness and guilt. The final theme was how these emotions created a "call to action," prompting participants to identify potential strategies to prevent future hypoglycemic events. CONCLUSION: This qualitative study highlights the emotional impact of patients' hypoglycemia on HCPs. Although it may have been expected that HCPs have a strong sense of professional responsibility, it was unexpected that these responses often became personal emotions. To ameliorate the negative impact of these responses on patient care, HCPs should engage in activities that enable them to anticipate and manage their own emotional responses. In addition, strategies to optimize hypoglycemia detection and prevention should be promoted.

Short-term intensive insulin as induction and maintenance therapy for the preservation of beta-cell function in early type 2 diabetes (RESET-IT Main): A 2-year randomized controlled trial.

AIM: To test the hypothesis that the addition of periodic courses of short-term intensive insulin therapy (IIT) could enhance the effect of metformin (MET) maintenance therapy on preservation of beta-cell function following induction IIT. METHODS: In this multicentre, randomized controlled trial, 108 adults with type 2 diabetes (median 1.3 years' duration; HbA1c 6.6% ± 0.6%) were randomized to 3 weeks of induction IIT (glargine, lispro) followed by MET maintenance, either with or without periodic 2-week courses of IIT every 3 months for 2 years. Beta-cell function was assessed by the Insulin Secretion Sensitivity Index-2 (ISSI-2) at an oral glucose tolerance test every 3 months. RESULTS: In both arms, induction IIT increased ISSI-2, improved whole-body insulin sensitivity and reduced hepatic insulin resistance (all P ≤ .0004). The primary outcome of baseline-adjusted ISSI-2 at 2 years was not improved by the addition of intermittent IIT (MET + IIT) and was slightly higher in the MET arm (baseline-adjusted difference -35 [95% CI: -66, -3]), with three additional beta-cell measures showing no significant differences. Baseline-adjusted HbA1c at 2 years did not differ between MET and MET + IIT (6.3% ± 0.1% vs. 6.4% ± 0.1%, P = .46), with 32.6% of participants in each arm maintaining HbA1c of 6.0% or less at 2 years. CONCLUSION: Although initial induction IIT induces metabolic improvement, subsequent repeat courses of IIT every 3 months do not further enhance the effect of MET maintenance therapy on beta-cell function.

Patient-centred innovation for multimorbidity care: a mixed-methods, randomised trial and qualitative study of the patients' experience.

BACKGROUND: Patient-centred interventions to help patients with multimorbidity have had mixed results. AIM: To assess the effectiveness of a provider-created, patient-centred, multi-provider case conference with follow-up, and understand under what circumstances it worked, and did not work. DESIGN AND SETTING: Mixed-methods design with a pragmatic randomised trial and qualitative study, involving nine urban primary care sites in Ontario, Canada. METHOD: Patients aged 18-80 years with ≥3 chronic conditions were referred to the Telemedicine IMPACT Plus intervention; a nurse and patient planned a multi-provider case conference during which a care plan could be created. The patients were randomised into an intervention or control group. Two subgroup analyses and a fidelity assessment were conducted, with the primary outcomes at 4 months being self-management and self-efficacy. Secondary outcomes were mental and physical health status, quality of life, and health behaviours. A thematic analysis explored the patients' experiences of the intervention. RESULTS: A total of 86 patients in the intervention group and 77 in the control group showed no differences, except that the intervention improved mental health status in the subgroup with an annual income of ≥C$50 000 (ß-coefficient 11.003, P = 0.006). More providers and follow-up hours were associated with poorer outcomes. Five themes were identified in the qualitative study: valuing the team, patients feeling supported, receiving a follow-up plan, being offered new and helpful additions to their treatment regimen, and experiencing positive outcomes. CONCLUSION: Overall, the intervention showed improvements only for patients who had an annual income of ≥C$50 000, implying a need to address the costs of intervention components not covered by existing health policies. Findings suggest a need to optimise team composition by revising the number and type of providers according to patient preferences and to enhance the hours of nurse follow-up to better support the patient in carrying out the case conference's recommendations.

Beyond the Sick Role: The Many Roles of Adults With Type 1 and Type 2 Diabetes in the Management of Hypoglycemia-The InHypo-DM Study, Canada.

OBJECTIVES: Hypoglycemia is a common adverse event for people with type 1 and type 2 diabetes mellitus. In this article, we explore the specific roles that individuals assume to prevent or treat hypoglycemia. METHODS: A descriptive qualitative study from the UnderstandINg the impact of HYPOglycemia on Diabetes Management Study (InHypo-DM) research program. A purposive sample of people with type 1 and type 2 diabetes were recruited for semistructured interviews. There were 16 participants (women and men), who were, on average, 53 years old. Average time since diagnosis was 15 (type 1) and 21 (type 2) years; all patients had at least 1 hypoglycemic event in the past year. Individual and team analysis of interviews were conducted to identify overarching themes. RESULTS: Participants articulated 4 roles in preventing or treating hypoglycemia. The first role was being a manager by assuming ownership and accountability for their own glycemic control. The second role, being a technician, used both subjective and objective information and employed specific strategies to respond to hypoglycemic events. The third role, educator, extended beyond self-management to increase others' awareness of hypoglycemia. The fourth role, advocate, involved championing one's own needs during a hypoglycemic event. These 4 roles were, in turn, influenced by the contexts of work, social settings, exercise and travel. CONCLUSIONS: These findings demonstrate that strategies that individuals use to avoid or reduce the severity of a hypoglycemic event extend beyond merely making impromptu decisions during events. Instead, these 4 roles of manager, technician, educator and advocate, embedded in specific contexts, enhanced their mastery in managing hypoglycemia in daily life.

Perspectives of specialists and family physicians in interprofessional teams in caring for patients with multimorbidity: a qualitative study.

BACKGROUND: Patients with multimorbidity often require services across different health care settings, yet team processes among settings are rarely implemented. We explored perceptions of specialists and family physicians collaborating in a telemedicine interprofessional consultation for patients with multimorbidity to better understand the value of bringing physicians together across the boundaries of health care settings. METHODS: This was a descriptive qualitative, interview-based study. Physicians who had previously participated in the Telemedicine Interprofessional Model of Practice for Aging and Complex Treatments (Telemedicine IMPACT Plus [TIP] Program) were invited to participate and asked to describe their experience of being a member of the program. Interviews were conducted from March to May 2016. We conducted an iterative and interpretive process using both individual and team analysis to identify themes. RESULTS: There were 15 participants, 9 specialists and 6 family physicians. Three themes emerged in the analysis: creating new perspectives on care for patients with multimorbidity by sharing knowledge, skills and attitudes; the shift from a consultant model to an interprofessional team model (allowing a window into the community, extending discussions beyond the medical model and focusing on the patient's health in context); and opportunities for learners, including learning about interprofessional collaboration and gaining exposure to a real-world model for caring for people with multimorbidity in outpatient settings. INTERPRETATION: Family physicians and specialists participating in a TIP Program believed the program improved their knowledge and skills, while also serving as an effective care delivery strategy. The findings also support that learners require more exposure to nontraditional consultant models in order to care for patients with multimorbidity effectively.

Living With Hypoglycemia: An Exploration of Patients' Emotions: Qualitative Findings From the InHypo-DM Study, Canada.

Hypoglycemia is one of the most common adverse events for people living with type 1 or type 2 diabetes. To gain a deeper understanding of patients' emotions regarding hypoglycemia, we conducted a descriptive qualitative study. Purposive sampling was used to recruit participants for a 30- to 45-minute semi-structured interview. The 16 participants included both women and men with either type 1 or type 2 diabetes, with a mean age of 53 years and mean time since diagnosis of 21 years. All participants had experienced more than one hypoglycemia event in the past year, ranging from nonsevere to severe. Data collection and analysis occurred in an iterative manner. Individual and team analyses of interviews were conducted to identify overarching themes and sub-themes. Thematic analysis revealed the unique interconnection among the emotions experienced by participants, including fear, anxiety, frustration, confidence, and hope. Time, experience, and reflection helped to build participants' confidence in their ability to manage a hypoglycemia event. Patients' emotions regarding hypoglycemia provide valuable insights into life with diabetes. Although hypoglycemia continues to evoke feelings of fear and anxiety, the role of hope may temper these emotions. Understanding the complex interplay of emotions concerning hypoglycemia can guide health care providers in improving clinical practice and promoting patient-centered interventions. Ultimately, health care providers can build patients' hypoglycemia-related confidence by using a strengths-based approach.

Clinical care gaps and solutions in diabetes and advanced chronic kidney disease: a patient-oriented qualitative research study.

BACKGROUND: Patients with diabetes and advanced chronic kidney disease face a high health care burden. As part of a patient-oriented research initiative to identify ways to better support patients' diabetes care, we explored their health care experience and solutions for patient-centred diabetes care. METHODS: We engaged 2 patients with advanced kidney disease and diabetes to join our multidisciplinary team as full research partners. They were involved in our design and conduct of the study, the analysis of the results and knowledge translation. We conducted qualitative interviews (1:1 semistructured interviews and focus groups) with patients with a history of both diabetes (type 1 or 2) and advanced kidney disease including those using dialysis. We identified overarching themes using individual and team analysis and conducted interviews until data saturation was reached. RESULTS: Twelve participants were interviewed between October 2017 and February 2018. Six people were interviewed in 2 separate focus groups (consisting of 4 and 2 participants) and 6 participated in 1:1 interviews with our team. Participants described being burdened by medical appointments, strict conflicting diets, costly diabetes therapies and fragmented, siloed health care. They indicated that self-management support, education and coordinated diabetes care might better support their diabetes care. INTERPRETATION: Patients with complex medical comorbidities face many challenges traversing a health care system organized around single diseases. Researchers and policy-makers should study and develop patient-centred diabetes care strategies to better support these high-risk patients.

A qualitative enquiry of hypoglycemia and the social determinants of health: The InHypo-DM study, Canada.

INTRODUCTION: A significant body of research exists on the impact of the social determinants of health (SDoHs) on diabetes care and general health outcomes. However, less is known about health care practitioners' (HCPs') perspectives and experiences regarding the impact of the SDoHs on their patients with Type I and Type 2 diabetes mellitus and how this affects the prevention and treatment of hypoglycemia. METHOD: A descriptive qualitative study, derived from the InHypo-DM (Canada) research program. A purposive sampling technique was used to recruit participants residing in southwestern Ontario, Canada, for a 30- to 45-min semistructured interview. Individual and team analysis of interviews was conducted to identify overarching and subthemes. Twenty HCP participants, including endocrinologists, family physicians, and allied health care practitioners, were recruited. Seven were Certified Diabetes Educators. RESULTS: Participants articulated 2 overarching components of the SDoHs: patients' socioeconomic issues and psychosocial issues. They highlighted two socioeconomic issues: occupation type and poverty. Participants also emphasized 3 areas pertaining to patients' psychosocial issues: stage in the life cycle (e.g., elderly), social isolation, and mental health. DISCUSSION: This study emphasizes the need for conducting detailed and comprehensive social histories during clinical diabetes assessments, as well as the necessity of adequate clinical time and resources for HCPs and patients to address these issues in the context of hypoglycemia management. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Results From a Feasibility Study of Square-Stepping Exercise in Older Adults With Type 2 Diabetes and Self-Reported Cognitive Complaints to Improve Global Cognitive Functioning.

OBJECTIVES: Adults with type 2 diabetes mellitus have an increased risk for dementia. Therefore, we proposed an intervention called the Square-stepping exercise (SSE) program to mitigate this risk. Our primary aim was to determine the feasibility of SSE in adults with type 2 diabetes and self-reported cognitive complaints. Our secondary aim was to determine whether 24 weeks of SSE improved cognition. Our tertiary aim was to determine whether SSE improved antisaccade reaction time, which is a measure of executive-related oculomotor control. METHODS: Adults >49 years with type 2 diabetes and self-reported cognitive complaints were randomized to an SSE group (2×/week for 24 weeks of SSE) or a control group. Feasibility was assessed by recruitment and attendance. Participants were assessed at baseline, after 12 weeks and after 24 weeks for global cognitive function, memory, planning, reasoning and concentration via a computer-based cognitive battery (Cambridge Brain Sciences) and antisaccade reaction time (at baseline and 24 weeks). RESULTS: Participants in the SSE group were (mean [SD]): 65.9 (5.2) years old; 33% female; body mass index 33.3 kg/m2 (4.8) (n=12). Participants in the control group were 71.2 (6.9) years old; 31% female; body mass index 31.9 kg/m2 (4.6) (n=13). Over 24 weeks, attendance was 70.2% (SD 17.2) for 4/12 participants. There were 4 withdrawals and 1 adverse event. There were no differences in global cognitive functioning. The SSE group improved in planning domain change scores between 12 and 24 weeks (F=5.8, p=0.03, ηp2=0.28) compared to controls. In the SSE group, we found a nonsignificant improvement in antisaccade reaction time of 38 ms (SD 16), n=2, compared to 9 ms (SD 45) in the control group, n=8. CONCLUSIONS: SSE should be evaluated further to improve its feasibility in older adults with type 2 diabetes. This study provides preliminary evidence that SSE improves executive function in adults with type 2 diabetes and self-reported cognitive complaints.

Real-world crude incidence of hypoglycemia in adults with diabetes: Results of the InHypo-DM Study, Canada.

OBJECTIVE: Very few real-world studies have been conducted to assess the incidence of diabetes-related hypoglycemia. Moreover, there is a paucity of studies that have investigated hypoglycemia among people taking secretagogues as a monotherapy or in combination with insulin. Accordingly, our research team developed and validated the InHypo-DM Person with Diabetes Mellitus Questionnaire (InHypo-DMPQ) with the aim of capturing the real-world incidence of self-reported, symptomatic hypoglycemia. The questionnaire was administered online to a national sample of Canadians (≥18 years old) with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) treated with insulin and/or insulin secretagogues. RESEARCH DESIGN AND METHODS: Self-report data obtained from the InHypo-DMPQ were descriptively analyzed to ascertain the crude incidence proportions and annualized incidence densities (rates) of 30-day retrospective non-severe and 1-year retrospective severe hypoglycemia, including daytime and nocturnal events. RESULTS: A total of 552 people (T2DM: 83%; T1DM: 17%) completed the questionnaire. Over half (65.2%) of the total respondents reported experiencing at least one event (non-severe or severe) at an annualized crude incidence density of 35.1 events per person-year. The incidence proportion and rate of non-severe events were higher among people with T1DM versus T2DM (77% and 55.7 events per person-year vs 54% and 28.0 events per person-year). Severe hypoglycemia was reported by 41.8% of all respondents, at an average rate of 2.5 events per person-year. CONCLUSIONS: The results of the InHypo-DMPQ, the largest real-world investigation of hypoglycemia epidemiology in Canada, suggest that the incidence of hypoglycemia among adults with diabetes taking insulin and/or insulin secretagogues is higher than previously thought.

Commentary on: "Effects of Regular Physical Activity on the Cognitive Performance of Type 2 Diabetic Patients: A Systematic Review" by Podolski et al. (Metab Syndr Relat Disord 2017;15:481-493).

Type 2 diabetes mellitus (T2DM) imparts an increased risk for cognitive decline, specifically executive function, which is important to maintain for diabetes self-management. There is evidence to suggest that exercise improves cognition in healthy older adults; however, the literature in adults with T2DM is lacking. This commentary is in complement to Podolski et al.'s systematic review evaluating the effects of physical activity on cognitive function in adults with T2DM. We have included eight additional studies and further highlight their conclusions on the heterogeneity of the literature thus far. Three current issues with the literature are as follows: (1) variability in interventions (e.g., aerobic, resistance, lifestyle, and yoga), (2) variability in cognitive outcome measures, and (3) lack of detailed description of the population studied, for example, baseline glycated hemoglobin (A1C) values. Overall, making it difficult to compare these studies and draw final conclusions. Thus, the efficacy for exercise to improve cognition in adults with T2DM is not yet well understood. Potential ways to mitigate these limitations could be for future studies that (1) use robust methodology whenever possible, that is, randomized controlled trials, (2) to follow current guideline-derived exercise recommendations for adults with T2DM, and (3) utilize cognitive outcome measures that are consistent across studies. The hope is that these consistencies in turn will help to determine the efficacy of exercise on cognitive function in adults with T2DM and therefore, allow national organizations to develop recommendations and guidelines for healthcare practitioners to follow.