Appropriateness and acceptability of continuous glucose monitoring in people with type 1 diabetes at rural first-level hospitals in Malawi: a qualitative study.

OBJECTIVES: The purpose of this qualitative study is to describe the acceptability and appropriateness of continuous glucose monitoring (CGM) in people living with type 1 diabetes (PLWT1D) at first-level (district) hospitals in Malawi. DESIGN: We conducted semistructured qualitative interviews among PLWT1D and healthcare providers participating in the study. Standardised interview guides elicited perspectives on the appropriateness and acceptability of CGM use for PLWT1D and their providers, and provider perspectives on the effectiveness of CGM use in Malawi. Data were coded using Dedoose software and analysed using a thematic approach. SETTING: First-level hospitals in Neno district, Malawi. PARTICIPANTS: Participants were part of a randomised controlled trial focused on CGM at first-level hospitals in Neno district, Malawi. Pretrial and post-trial interviews were conducted for participants in the CGM and usual care arms, and one set of interviews was conducted with providers. RESULTS: Eleven PLWT1D recruited for the CGM randomised controlled trial and five healthcare providers who provided care to participants with T1D were included. Nine PLWT1D were interviewed twice, two were interviewed once. Of the 11 participants with T1D, six were from the CGM arm and five were in usual care arm. Key themes emerged regarding the appropriateness and effectiveness of CGM use in lower resource setting. The four main themes were (a) patient provider relationship, (b) stigma and psychosocial support, (c) device usage and (d) clinical management. CONCLUSIONS: Participants and healthcare providers reported that CGM use was appropriate and acceptable in the study setting, although the need to support it with health education sessions was highlighted. This research supports the use of CGM as a component of personalised diabetes treatment for PLWT1D in resource constraint settings. TRIAL REGISTRATION NUMBER: PACTR202102832069874; Post-results.

Feasibility of continuous glucose monitoring in patients with type 1 diabetes at two district hospitals in Neno, Malawi: a randomised controlled trial.

OBJECTIVES: To assess the feasibility and change in clinical outcomes associated with continuous glucose monitoring (CGM) use among a rural population in Malawi living with type 1 diabetes. DESIGN: A 2:1 open randomised controlled feasibility trial. SETTING: Two Partners In Health-supported Ministry of Health-run first-level district hospitals in Neno, Malawi. PARTICIPANTS: 45 people living with type 1 diabetes (PLWT1D). INTERVENTIONS: Participants were randomly assigned to Dexcom G6 CGM (n=30) use or usual care (UC) (n=15) consisting of Safe-Accu glucose monitors and strips. Both arms received diabetes education. OUTCOMES: Primary outcomes included fidelity, appropriateness and severe adverse events. Secondary outcomes included change in haemoglobin A1c (HbA1c), acceptability, time in range (CGM arm only) SD of HbA1c and quality of life. RESULTS: Participants tolerated CGM well but were unable to change their own sensors which resulted in increased clinic visits in the CGM arm. Despite the hot climate, skin rashes were uncommon but cut-out tape overpatches were needed to secure the sensors in place. Participants in the CGM arm had greater numbers of dose adjustments and lifestyle change suggestions than those in the UC arm. Participants in the CGM arm wore their CGM on average 63.8% of the time. Participants in the UC arm brought logbooks to clinic 75% of the time. There were three hospitalisations all in the CGM arm, but none were related to the intervention. CONCLUSIONS: This is the first randomised controlled trial conducted on CGM in a rural region of a low-income country. CGM was feasible and appropriate among PLWT1D and providers, but inability of participants to change their own sensors is a challenge. TRIAL REGISTRATION NUMBER: PACTR202102832069874.

Peer Support in the Management of Diabetes to Improve Cardiovascular Disease Outcomes in Low- and Middle-Income Countries (LMICs).

Diabetes and cardiovascular disease (CVD) contribute to significant morbidity and mortality in low-resource settings. Living with diabetes can be overwhelming, isolating, and exhausting, even in settings of resource availability and health care access, while the psychosocial burden of living with diabetes and CVD can be exacerbated by an increased burden of social determinants of health in low-resource settings. Diabetes and CVD care heavily rely on self-management, and health care professionals are now recognizing the importance of peer support in supporting healthy behaviors, psychosocial well-being, and improved clinical outcomes. However, there is currently a lack of consistency in how peer support programs are defined, implemented, and evaluated.

Health system capacity to manage diabetic ketoacidosis in nine low-income and lower-middle income countries: A cross-sectional analysis of nationally representative survey data.

Background: There has been increasing awareness about the importance of type 1 diabetes (T1D) globally. Diabetic ketoacidosis (DKA) is a life-threatening complication of T1D in low-income settings. Little is known about health system capacity to manage DKA in low- and lower-middle income countries (LLMICs). As such, we describe health system capacity to diagnose and manage DKA across nine LLMICs using data from Service Provision Assessments. Methods: In this cross-sectional study, we used data from Service Provision Assessment (SPA) surveys, which are part of the Demographic and Health Survey (DHS) Program. We defined an item set to diagnose and manage DKA in higher-level (tertiary or secondary) facilities, and a set to assess and refer patients presenting to lower-level (primary) facilities. We quantified each item's availability by service level in Bangladesh (Survey 1: May 22 2014-Jul 20 2014; Survey 2: Jul 2017-Oct 2017), the Democratic Republic of the Congo (DRC) (Oct 16 2017-Nov 24 2017 in Kinshasha; Aug 08 2018-Apr 20 2018 in rest of country), Haiti (Survey 1: Mar 05 2013-Jul 2013; Survey 2: Dec 16 2017-May 09 2018), Ethiopia (Feb 06 2014-Mar 09 2014), Malawi (Phase 1: Jun 11 2013-Aug 20 2013; Phase 2: Nov 13 2013-Feb 7 2014), Nepal (Phase 1: Apr 20 2015-Apr 25 2015; Phase 2: Jun 04 2015-Nov 05 2015), Senegal (Survey 1: Jan 2014-Oct 2014; Survey 2: Feb 09 2015-Nov 10 2015; Survey 3: Feb 2016-Nov 2016; Survey 4: Mar 13 2017-Dec 15 2017; Survey 5: Apr 15 2018-Dec 31 2018; Survey 6: Apr 15 2019-Feb 28 2020), Tanzania (Oct 20 2014-Feb 21 2015), and Afghanistan (Nov 1 2018-Jan 20 2019). Variation in secondary facilities' capacity and trends over time were also explored. Findings: We examined data from 2028 higher-level and 7534 lower-level facilities. Of these, 1874 higher-level and 6636 lower-level facilities' data were eligible for analysis. Availability of all item sets were low at higher-level facilities, where less than 50% had the minimal set of supplies, less than 20% had the full minimal set, and less than 15% had the ideal set needed to diagnose and manage DKA. Across countries in lower-level facilities, less than 14% had the minimal set of supplies and less than 9% the full set of supplies for diagnosis and transfer of DKA patients. No country had more than 20% of facilities with the minimal set of items needed to assess or manage DKA. Where data were available for more than one survey (Bangladesh, Senegal, and Haiti), changes in availability of the minimal set and ideal set of items did not exceed 15%. Tertiary facilities performed best in Haiti, Ethiopia, Malawi, Nepal, Senegal, Tanzania, and Afghanistan. Secondary facilities that were rural, public, and had fewer staff had lower capacity. Interpretation: Health system capacity to manage DKA was low across these nine LLMICs. Although efforts are underway to strengthen health systems, a specific focus on DKA management is still needed. Funding: Leona M. and Harry B. Helmsley Charitable Trust, and Juvenile Diabetes Research Foundation Ltd.

Evaluating implementation of Diabetes Self-Management Education in Maryland County, Liberia: protocol for a pilot prospective cohort study.

INTRODUCTION: Achieving glycaemic targets for people living with diabetes (PLWD) is challenging, especially in settings with limited resources. Programmes need to address gaps in knowledge, skills and self-management. Diabetes Self-Management Education (DSME) is an evidence-based intervention to educate and empower PLWD to improve self-management activities. This protocol describes a pilot study assessing the feasibility, acceptability and effect on clinical outcomes of implementing DSME in clinics caring for people living with insulin-dependent diabetes in Liberia. METHODS AND ANALYSIS: Our protocol is a three-phased, mixed-methods, quasi-experimental prospective cohort study. Phase 1 focuses on (a) establishing a Patient Advisory Board and (b) training providers in DSME who provide care for PLWD. In phase 2, clinicians will implement DSME. In phase 3, we will train additional providers who interact with PLWD.We will assess whether this DSME programme can lead to increased provider knowledge of DSME, improvements in diabetes self-management behaviours, glycaemic control, diabetes knowledge and psychosocial well-being, and a reduction in severe adverse events. Primary outcomes of interest are implementation outcomes and change in frequency of self-management behaviours by patients. Secondary outcomes include change in haemoglobin A1c, psychosocial well-being, severe adverse events and change in provider knowledge of DSME. ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of Liberia Institutional Review Board (IRB) and the Brigham and Women's Hospital IRB. Findings from the study will be shared with local and national clinical and programmatic stakeholders and published in an open-access, peer-reviewed journal.

Protocol for a feasibility randomised control trial for continuous glucose monitoring in patients with type 1 diabetes at first-level hospitals in rural Malawi.

INTRODUCTION: The majority of people living with type 1 diabetes (PLWT1D) struggle to access high-quality care in low-income countries (LICs), and lack access to technologies, including continuous glucose monitoring (CGM), that are considered standard of care in high resource settings. To our knowledge, there are no studies in the literature describing the feasibility or effectiveness of CGM at rural first-level hospitals in LICs. METHODS AND ANALYSIS: This is a 3-month, 2:1 open-randomised trial to assess the feasibility and clinical outcomes of introducing CGM to the entire population of 50 PLWT1D in two hospitals in rural Neno, Malawi. Participants in both arms will receive 2 days of training on diabetes management. One day of training will be the same for both arms, and one will be specific to the diabetes technology. Participants in the intervention arm will receive Dexcom G6 CGM devices with sensors and solar chargers, and patients in the control arm will receive Safe-Accu home glucose metres and logbooks. All patients will have their haemoglobin A1c (HbA1c) measured and take WHO Quality of Life assessments at study baseline and endline. We will conduct qualitative interviews with a selection of participants from both arms at the beginning and end of study and will interview providers at the end of the study. Our primary outcomes of interest are fidelity to protocols, appropriateness of technology, HbA1c and severe adverse events. ETHICS AND DISSEMINATION: This study is approved by National Health Sciences Research Committee of Malawi (IRB Number IR800003905) and the Mass General Brigham (IRB number 2019P003554). Findings will be disseminated to PLWT1D through health education sessions. We will disseminate any relevant findings to clinicians and leadership within our study catchment area and networks. We will publish our findings in an open-access peer-reviewed journal. TRIAL REGISTRATION NUMBER: PACTR202102832069874.

Assessing disparities in barriers to attending pediatric diabetes camp.

OBJECTIVES: While the benefits of diabetes camp programs are well established, minority youth are underrepresented in camp attendance. No research to date has explored barriers to camp attendance or potential disparities in those barriers. Further, little is known about sources families prioritize in seeking diabetes information and support. METHODS: This was a prospective survey of families of children with type 1 diabetes (T1D) using convenience sampling during normally-scheduled clinic visits. Thirty-nine children and their caregivers completed the survey. Results were analyzed for prevalence and mean number of reported barriers, benefits, and diabetes information networks. RESULTS: Age range was 5-15 years and mean duration of diabetes was 2.9 years (0.4-9y). The most prevalent barriers were location, cost, and concern about sending children to overnight camp. Caregivers had high level of knowledge of camp benefits. Participants reported engaging with the diabetes community through interactions with their diabetes team, Facebook groups, and the JDRF. CONCLUSION: Increasing awareness, transportation assistance, and scholarship funding all may increase accessibility of diabetes camps. Diabetes clinic and online or social media groups are both acceptable means of disseminating information about diabetes camp. Further research is indicated to verify if these results are applicable to the larger diabetes community.

Eye-Tracking Based Attention Bias Modification (ET-ABM) Facilitates Disengagement from Negative Stimuli in Dysphoric Individuals.

To address shortcomings of purely reaction-time based attention bias modification (ABM) paradigms, a novel eye-tracking based ABM training (ET-ABM) was developed. This training targets the late disengagement from negative stimuli and the lack of attention for positive information, which are characteristics of depression. In the present study, 75 dysphoric students (BDI ≥ 9) were randomly assigned to either this positive training (PT), or a sham-training (ST) that did not train any valence-specific gaze pattern (positive and negative pictures had to be disengaged from and attended to equally often). Results showed that the PT induced a positive attentional bias (longer fixations of positive than negative pictures). Although the ST group showed an increase in positive attentional bias as well, this increase was not as strong as in the PT group. Compared to the ST, the PT specifically induced faster disengagement from negative pictures. No differential training effects were found on stress responses or state rumination. These results show that the ET-ABM successfully modifies attentional processes, specifically late disengagement from negative stimuli, in dysphoric students, and hence might be a promising alternative to existing ABM paradigms.

Working mechanisms of a general positivity approach-avoidance training: Effects on action tendencies as well as on subjective and physiological stress responses.

BACKGROUND AND OBJECTIVES: The general positivity training, a Cognitive Bias Modification procedure modifying individuals' approach-avoidance tendencies to positively and negatively valenced pictures by means of a joystick task, has been proven effective in attenuating stress reactivity in dysphoric students. The present study explored which training component (pull positive pictures, push negative pictures, or both) is the active one in changing action tendencies and stress responses. METHODS: Two-hundred-and-thirteen students completed one of four approach-avoidance trainings before being exposed to a stressful speech-task: The general positivity training (pull positive and push negative pictures), a training to approach positive pictures and avoid empty pictures (ApP), a training to avoid negative pictures and approach empty pictures (AvN), or a sham-training. RESULTS: The pattern of results suggests that the groups trained to avoid negative pictures showed a stronger increase in positive approach-avoidance tendencies than the other two groups. However, only the positivity training induced significant within-group changes in positive bias. The groups further did not differ in self-report or cardiovascular measures of anxiety in response to the stress-task. Instead, the training affected mood directly: Exposure to negative pictures during the training increased state anxiety. LIMITATIONS: Generalizability of the findings is limited by using an unselected student sample. Also, the use of empty pictures as neutral stimuli in the ApP and AvN could have weakened training effects in these groups. CONCLUSIONS: Although our results hint at the importance of avoiding negative pictures for modifying an approach-avoidance bias, only the positivity training with both components may effectively induce a positive bias. Remarkably, we failed to replicate and extend previously reported effects of the training on stress-responses. Hence, it remains questionable whether the changes in bias reflect changes in underlying cognitive processing tendencies or task-specific learning effects.

Investigating the (cost-) effectiveness of attention bias modification (ABM) for outpatients with major depressive disorder (MDD): a randomized controlled trial protocol.

BACKGROUND: Despite the range of available, evidence-based treatment options for Major Depressive Disorder (MDD), the rather low response and remission rates suggest that treatment is not optimal, yet. Computerized attention bias modification (ABM) trainings may have the potential to be provided as cost-effective intervention as adjunct to usual care (UC), by speeding up recovery and bringing more patients into remission. Research suggests, that a selective attention for negative information contributes to development and maintenance of depression and that reducing this negative bias might be of therapeutic value. Previous ABM studies in depression, however, have been limited by small sample sizes, lack of long-term follow-up measures or focus on sub-clinical samples. This study aims at evaluating the long-term (cost-) effectiveness of internet-based ABM, as add-on treatment to UC in adult outpatients with MDD, in a specialized mental health care setting. METHODS/DESIGN: This study presents a double-blind randomized controlled trial in two parallel groups with follow-ups at 1, 6, and 12 months, combined with an economic evaluation. One hundred twenty six patients, diagnosed with MDD, who are registered for specialized outpatient services at a mental health care organization in the Netherlands, are randomized into either a positive training (towards positive and away from negative stimuli) or a sham training, as control condition (continuous attentional bias assessment). Patients complete eight training sessions (seven at home) during a period of two weeks (four weekly sessions). Primary outcome measures are change in attentional bias (pre- to post-test), mood response to stress (at post-test) and long-term effects on depressive symptoms (up to 1-year follow-up). Secondary outcome measures include rumination, resilience, positive and negative affect, and transfer to other cognitive measures (i.e., attentional bias for verbal stimuli, cognitive control, positive mental imagery), as well as quality of life and costs. DISCUSSION: This is the first study investigating the long-term effects of ABM in adult outpatients with MDD, alongside an economic evaluation. Next to exploring the mechanism underlying ABM effects, this study provides first insight into the effects of combining ABM and UC and the potential implementation of ABM in clinical practice. TRIAL REGISTRATION: Trialregister.nl, NTR5285 . Registered 20 July 2015.

Can't Look Away: An Eye-Tracking Based Attentional Disengagement Training for Depression.

To address shortcomings of purely reaction-time based attentional bias modification (ABM) paradigms, we developed an ABM task that is controlled by eye-tracking. This task allows to assess and train both disengagement from negative pictures and maintained attention to positive pictures. As a proof-of-principle study with an unselected student sample, this positive training (PT; N = 44) was compared to a negative training (NT; N = 42), which reinforced the opposite attentional pattern. Importantly, training trials were completed only if participants performed the correct gaze patterns. Results showed that higher depression levels were associated with slower disengagement from negative stimuli at baseline. As expected, the PT induced longer fixations on positive pictures and faster disengagement from negative pictures. The NT showed no changes in attentional processes. The groups did not differ in mood reactivity and recovery from a stressor. Advantages of using eye-tracking in ABM and potential applications of the training are discussed.

Always Approach the Bright Side of Life: A General Positivity Training Reduces Stress Reactions in Vulnerable Individuals.

Emotional disorders are characterized by cognitive biases towards negative stimuli, and a lack of biases towards positive ones. Therefore, we developed a cognitive bias modification training, modifying approach-avoidance tendencies to diverse emotional pictures. In Study 1, a negative training (pull negative, push positive pictures) was compared to a positive training (vice versa) in 141 students. The pre-existing positivity bias remained after positive training, but reversed into a negativity bias after negative training. This effect transferred to an attentional bias. The training affected neither mood nor emotional vulnerability to stress. In Study 2, we investigated the effects of the positive training in 102 dysphoric and non-dysphoric students, all in a sad mood state. Compared to placebo training, the positive training strengthened a positivity bias, and it reduced emotional vulnerability in dysphoric students. This suggests potential therapeutic value of the training, but further studies are needed.

Randomized trial of infusion set function: steel versus teflon.

BACKGROUND: This study compared infusion set function for up to 1 week using either a Teflon(®) (Dupont(™), Wilmington, DE) catheter or a steel catheter for insulin pump therapy in type 1 diabetes mellitus. SUBJECTS AND METHODS: Twenty subjects participating in a randomized, open-labeled, crossover study were asked to wear two Quick-Set(®) and two Sure-T(®) infusion sets (both from Medtronic Minimed, Northridge, CA) until the infusion set failed or was worn for 1 week. All subjects wore a MiniMed continuous glucose monitoring system for the duration of the study. RESULTS: One subject withdrew from the study. There were 38 weeks of Sure-T wear and 39 weeks of Quick-Set wear with no difference in the survival curves of the infusion sets. There was, however, a 15% initial failure rate with the Teflon infusion set. After 7 days, both types of infusion sets had a 64% failure rate. Overall, 30% failed because of hyperglycemia and a failed correction dose, 13% were removed for pain, 10% were pulled out by accident, 10% had erythema and/or induration of>10 mm, 5% fell out because of loss of adhesion, and 4% were removed for infection. The main predictor of length of wear was the individual subject. There was no increase in hyperglycemia or daily insulin requirements when an infusion set was successfully used for 7 days (n=25 of 77 weeks). CONCLUSIONS: We found no difference between steel and Teflon infusion sets in their function over 7 days, although 15% of Teflon sets failed because of kinking on insertion. The strongest predictor of prolonged 7-day infusion set function was the individual subject, not the type of infusion set.