EMBARK: A Randomized, Controlled Trial Comparing Three Approaches to Reducing Diabetes Distress and Improving HbA1c in Adults With Type 1 Diabetes.

OBJECTIVE: To compare the effectiveness of three interventions to reduce diabetes distress (DD) and improve HbA1c among adults with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: Individuals with T1D (n = 276) with elevated DD (a score >2 on the total Type 1 Diabetes Distress Scale) and HbA1c (>7.5%) were recruited from multiple settings and randomly assigned to one of three virtual group-based programs: 1) Streamline, an educator-led education and diabetes self-management program; 2) TunedIn, a psychologist-led program focused exclusively on emotional-focused DD reduction; or 3) FixIt, an integration of Streamline and TunedIn. Assessments of the primary outcomes of DD and HbA1c occurred at baseline and at 3, 6, and 12 months. RESULTS: All three programs demonstrated substantive and sustained reductions in DD (Cohen's d = 0.58-1.14) and HbA1c (range, -0.4 to -0.72) at 12-month follow-up. TunedIn and FixIt participants reported significantly greater DD reductions compared with Streamline participants (P = 0.007). Streamline and TunedIn participants achieved significantly greater HbA1c reductions than did FixIt participants (P = 0.006). CONCLUSIONS: DD can be successfully reduced among individuals with T1D with elevated HbA1c using both the educational/behavioral and emotion-focused approaches included in the study. Although both approaches are associated with significant and clinically meaningful reductions in DD and HbA1c, TunedIn, the emotion-focused program, had the most consistent benefits across both DD and HbA1c. The study findings suggest the overall value of group-based, fully virtual, and time-limited emotion-focused strategies, like those used in TunedIn, for adults with T1D.

Healthy food delivery for type 2 diabetes management in rural clinics' patients: A comparative effectiveness randomized controlled trial protocol.

BACKGROUND: Rural populations experience a higher prevalence of both food insecurity and type 2 diabetes mellitus (T2DM) than metropolitan populations and face many challenges in accessing resources essential to optimal T2DM self-management. This study aims to address these challenges by delivering a T2DM-appropriate food box and recipes directly to rural participants' homes. METHODS: This is a comparative effectiveness randomized controlled trial including 400 English- or Spanish-speaking rural adult participants with T2DM (HbA1c ≥6.5%) experiencing food insecurity. Participants are randomly assigned to a 3-month Healthy Food Delivery Intervention (HFDI) plus one 60-min virtual consultation with a diabetes educator or consultation only. The HFDI includes a weekly food box delivery with recipes. Data are collected at pre-intervention, 3-months (post-intervention), 9-months, and 15-months. The primary outcome is change in HbA1c, with secondary measures including diet quality (Healthy Eating Index-2015, calculated from one 24-h dietary recall at each data collection time point), cardio-metabolic risk factors (i.e., blood pressure, lipids, body mass index, glucose), and patient-centered outcomes (e.g., T2DM self-efficacy, T2DM-related distress). Process evaluation data (e.g., successful food box deliveries, diabetes educator consultation attendance, intervention satisfaction) are collected during and post-intervention (3-months). A cost-effectiveness analysis based on traditional cost per quality-adjusted life year gain thresholds will be conducted to estimate the incremental cost-effectiveness between HFDI plus consultation and consultation alone. CONCLUSION: Findings from this study will provide evidence regarding the effectiveness of an intervention that promotes participant adherence and improves access to healthy food. CLINICAL TRIAL REGISTRATION: NCT04876053.

Lessons learned from the pilot family model of diabetes self-management intervention in the Republic of the Marshall Islands.

Background: The Republic of the Marshall Islands (RMI) has a high rate of type 2 diabetes mellitus (T2DM). To address the high rate of T2DM, we tested a culturally adapted family model of diabetes self-management education and support (F-DSMES). We report the results of the 12-month post-intervention data collection and describe the lessons learned from the delivery of the F-DSMES intervention. Methods: Recruitment took place in four churches in Majuro and included 10 h of content delivered over 8-10 weeks. Forty-one participants with T2DM were included. The primary study outcome was glycemic control measured by a change in HbA1c. We also conducted participant interviews to document the participant-reported barriers encountered during the F-DSMES intervention. Results: Participants did not show improvements in their biometric markers; however, participants did show improvement on multiple measures of diabetes knowledge and family support. We identified five areas to improve future interventions: 1) issues with recruitment, retention, and attendance; 2) needing help accessing information and additional healthcare provider counseling; 3) struggles with adhering to diet recommendations; 4) difficulty getting exercise, and 5) improving lessons within the intervention. Conclusion: Although the biomarker data did not show improvement, valuable information was gained to improve the development of larger-scale trials. The results provide evidence of the need for these trials and the desire of participants to continue pursuing this effort. Others doing similar work in other low-to-middle income countries will need to take into consideration the potential barriers and facilitators within participants' social and physical environments.

Study protocol for family model diabetes self-management education with Marshallese participants in faith-based organizations.

Background: Culturally-appropriate family models of diabetes self-management education and support (DSMES) using community health workers (CHWs) have been shown to help address barriers to improving type 2 diabetes mellitus (T2DM) self-management for racial/ethnic minority communities; however, there is limited DSMES research among Marshallese and other Pacific Islanders. Using a community-based participatory research approach, we engaged community stakeholders to co-design a study to implement a culturally adapted family model DSMES (F-DSMES) intervention in faith-based organizations (FBOs) (i.e., churches). Methods: Using a cluster-randomized controlled trial design, we will assess the effectiveness of the F-DSMES intervention for Marshallese patients with T2DM in Arkansas and Oklahoma. Twenty-four FBOs (with 12 primary participants per FBO) will be randomized to one of two study arms: the intervention arm or the wait-list control arm. Primary participants must have at least one family member willing to attend education sessions and data collection events. The F-DSMES intervention consists of ten h of diabetes education delivered by CHWs over eight to ten weeks. Data will be collected from the intervention arm at pre-intervention (baseline), immediate post-intervention (12 weeks), and three months post-intervention. The wait-list control arm will complete a second pre-intervention data collection before receiving the intervention. The primary study outcome will be glycemic control, as measured by HbA1c. Secondary measures include glucose, weight, body mass index, blood pressure, diabetes self-management behaviors, and diabetes management self-efficacy. Conclusion: The knowledge gained from this research will inform future DSMES and other health promotion interventions conducted with Marshallese and other Pacific Islander communities.

Human islet preparations distributed for research exhibit a variety of insulin-secretory profiles.

Human islet research is providing new insights into human islet biology and diabetes, using islets isolated at multiple US centers from donors with varying characteristics. This creates challenges for understanding, interpreting, and integrating research findings from the many laboratories that use these islets. In what is, to our knowledge, the first standardized assessment of human islet preparations from multiple isolation centers, we measured insulin secretion from 202 preparations isolated at 15 centers over 11 years and noted five distinct patterns of insulin secretion. Approximately three quarters were appropriately responsive to stimuli, but one quarter were dysfunctional, with unstable basal insulin secretion and/or an impairment in stimulated insulin secretion. Importantly, the patterns of insulin secretion by responsive human islet preparations (stable Baseline and Fold stimulation of insulin secretion) isolated at different centers were similar and improved slightly over the years studied. When all preparations studied were considered, basal and stimulated insulin secretion did not correlate with isolation center, biological differences of the islet donor, or differences in isolation, such as Cold Ischemia Time. Dysfunctional islet preparations could not be predicted from the information provided by the isolation center and had altered expression of genes encoding components of the glucose-sensing pathway, but not of insulin production or cell death. These results indicate that insulin secretion by most preparations from multiple centers is similar but that in vitro responsiveness of human islets cannot be predicted, necessitating preexperimental human islet assessment. These results should be considered when one is designing, interpreting, and integrating experiments using human islets.

Multimodal image coregistration and inducible selective cell ablation to evaluate imaging ligands.

We combined multimodal imaging (bioluminescence, X-ray computed tomography, and PET), tomographic reconstruction of bioluminescent sources, and two unique, complementary models to evaluate three previously synthesized PET radiotracers thought to target pancreatic beta cells. The three radiotracers {[(18)F]fluoropropyl-(+)-dihydrotetrabenazine ([(18)F]FP-DTBZ), [(18)F](+)-2-oxiranyl-3-isobutyl-9-(3-fluoropropoxy)-10-methoxy-2,3,4,6,7,11b-hexahydro-1H-pyrido[2,1-a]isoquinoline ((18)F-AV-266), and (2S,3R,11bR)-9-(3-fluoropropoxy)-2-(hydroxymethyl)-3-isobutyl-10-methoxy-2,3,4,6,7,11b-hexahydro-1H-pyrido[2,1-a]isoquinolin-2-ol ((18)F-AV-300)} bind vesicular monoamine transporter 2. Tomographic reconstruction of the bioluminescent signal in mice expressing luciferase only in pancreatic beta cells was used to delineate the pancreas and was coregistered with PET and X-ray computed tomography images. This strategy enabled unambiguous identification of the pancreas on PET images, permitting accurate quantification of the pancreatic PET signal. We show here that, after conditional, specific, and rapid mouse beta-cell ablation, beta-cell loss was detected by bioluminescence imaging but not by PET imaging, given that the pancreatic signal provided by three PET radiotracers was not altered. To determine whether these ligands bound human beta cells in vivo, we imaged mice transplanted with luciferase-expressing human islets. The human islets were imaged by bioluminescence but not with the PET ligands, indicating that these vesicular monoamine transporter 2-directed ligands did not specifically bind beta cells. These data demonstrate the utility of coregistered multimodal imaging as a platform for evaluation and validation of candidate ligands for imaging islets.

Reduction of surgical mortality and morbidity in diabetic patients undergoing cardiac surgery with a combined intravenous and subcutaneous insulin glucose management strategy.

OBJECTIVE: To determine if glucose management in postcardiothoracic surgery patients with a combined intravenous (IV) and subcutaneous (SC) insulin regimen reduces mortality and morbidity in patients with diabetes and stress-induced hyperglycemia. RESEARCH DESIGN AND METHODS: Retrospective review of 614 consecutive patients who underwent cardiothoracic (CT) surgery in 2005 was performed to evaluate the incidence and treatment of postoperative hyperglycemia and operative morbidity and mortality. Hyperglycemic patients (glucose >6.05 mmol/l) were treated with IV insulin in the intensive care unit (ICU) followed by SC insulin (outside ICU). Subgroup analysis was performed on 159 coronary artery bypass grafting (CABG)-only patients. RESULTS: Among all CT surgeries, patients with a preoperative diagnosis of diabetes had higher rates of postoperative mortality (7.3 vs. 3.3%; P = 0.03) and pulmonary complications (19.5 vs. 11.6%; P = 0.02) but had similar rates of infections and cardiac, renal, and neurological complications on univariate analysis. However, on multivariate analysis, a preoperative diagnosis of diabetes was not a significant factor in postoperative mortality or pulmonary complications. In CABG-only patients, no significant differences were seen in outcomes between diabetic and nondiabetic patients. Independent of diabetic status, glucose > or =11 mmol/l on ICU admission was predictive of higher rates of mortality and renal, pulmonary, and cardiac postoperative complications. CONCLUSIONS: A combination of IV insulin (in the ICU) and SC insulin (outside the ICU), a less costly and less nursing-intensive therapy than 3 days of IV insulin postoperatively, results in a reduction of the increased surgical morbidity and mortality in diabetic patients after CT surgery.