Specialized Technology Education for Pumps and Pens in Underserved Populations with Diabetes.

Background: Health care disparities in the use of diabetes devices are particularly prevalent, especially given the high levels of health literacy and numeracy needed to understand their use. Methods: To reduce this gap, we created lower literacy, English and Spanish multicultural guides for insulin pen and pump use. Focus groups provided input, nonbranded illustrations were designed, and simplified text was developed. The guides were implemented in our clinic for underresourced individuals in East Los Angeles, California. Subjects given the low literacy guides participated in guide-driven individual and group education, and measures were administered at baseline, 6 and 12 months. Results: Sixty-three adults with type 1 diabetes (T1D) were included, and 43 (68%) completed all 12 months of the study. Initial HbA1c was 9.2 ± 1.97 (standard deviation) with no change over the study course (12-month A1C = 9.3 ± 1.92). However, participants showed significantly reduced psychological distress due to diabetes, increased diabetes knowledge, improved self-report of health, and a trend toward reduced depression. There was also a reduction in rates of diabetic ketoacidosis (DKA). There was no change in rates of hypoglycemia, although there was an increase in fear of hypoglycemia. Conclusions: Appropriately targeted teaching guides can be used to improve various patient-reported outcomes in people with T1D, specifically, overall self-report of health, distress due to diabetes, and diabetes knowledge. Targeted teaching guides also achieved improvements in rates of DKA in T1D. While these results are encouraging, more work is needed to make a significant impact on glycemic control. Clinical Trials registration number: NCT04550585.

Function and Emotion in Everyday Life With Type 1 Diabetes (FEEL-T1D): Protocol for a Fully Remote Intensive Longitudinal Study.

BACKGROUND: Although short-term blood glucose levels and variability are thought to underlie diminished function and emotional well-being in people with type 1 diabetes (T1D), these relationships are poorly understood. The Function and Emotion in Everyday Life with T1D (FEEL-T1D) study focuses on investigating these short-term dynamic relationships among blood glucose levels, functional ability, and emotional well-being in adults with T1D. OBJECTIVE: The aim of this study is to present the FEEL-T1D study design, methods, and study progress to date, including adaptations necessitated by the COVID-19 pandemic to implement the study fully remotely. METHODS: The FEEL-T1D study will recruit 200 adults with T1D in the age range of 18-75 years. Data collection includes a comprehensive survey battery, along with 14 days of intensive longitudinal data using blinded continuous glucose monitoring, ecological momentary assessments, ambulatory cognitive tasks, and accelerometers. All study procedures are conducted remotely by mailing the study equipment and by using videoconferencing for study visits. RESULTS: The study received institutional review board approval in January 2019 and was funded in April 2019. Data collection began in June 2020 and is projected to end in December 2021. As of June 2021, after 12 months of recruitment, 124 participants have enrolled in the FEEL-T1D study. Approximately 87.6% (7082/8087) of ecological momentary assessment surveys have been completed with minimal missing data, and 82.0% (82/100) of the participants provided concurrent continuous glucose monitoring data, ecological momentary assessment data, and accelerometer data for at least 10 of the 14 days of data collection. CONCLUSIONS: Thus far, our reconfiguration of the FEEL-T1D protocol to be implemented remotely during the COVID-19 pandemic has been a success. The FEEL-T1D study will elucidate the dynamic relationships among blood glucose levels, emotional well-being, cognitive function, and participation in daily activities. In doing so, it will pave the way for innovative just-in-time interventions and produce actionable insights to facilitate tailoring of diabetes treatments to optimize the function and well-being of individuals with T1D. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30901.

Team clinic: Expansion of a multidisciplinary care model for adolescents with type 1 diabetes.

BACKGROUND: Adolescent and young adults (AYA) with Type 1 Diabetes (T1D) experience more difficulty with glycemic control than patients in all other age groups. The shared medical appointment (SMA) model has been effective in multiple healthcare populations, but the feasibility and effectiveness of SMA in AYA patients with T1D is unclear. METHODS: This research leverages the team's multidisciplinary expertise to develop an engaging intervention toolkit and test the implementation of the Team Clinic care model for the treatment of T1D among middle school adolescents in a large urban children's hospital serving an economically, racially and ethnically diverse population. In Phase 1, the team will manualize the Team Clinic care model into an engaging, age-appropriate educational and intervention toolkit. In Phase 2, the team will conduct a randomized clinical trial to test the feasibility and usability of the toolkit from the provider perspective (team member satisfaction; clinical efficiency; compliance with American Diabetes Association, American Association of Diabetes Educators, and California Children's Services standards; and payor-level cost data) and the preliminary efficacy of the intervention toolkit on patient- and family-level outcomes (attendance, acceptability/satisfaction with care, patient-level cost data, diabetes outcomes, diabetes family conflict, diabetes distress, and depression). DISCUSSION: AYA patients with T1D often receive care in clinics and institutions with limited resources and time. This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards. Trial registration The study is registered with ClinicalTrials.gov (Protocol Record: NCT04190368).

Clinical and Psychosocial Outcomes of a Structured Transition Program Among Young Adults With Type 1 Diabetes.

PURPOSE: We identified and treated young adults with type 1 diabetes who had been lost to follow-up during their transfer from pediatric to adult care, comparing their clinical, psychosocial, and health care utilization outcomes to participants receiving continuous care (CC) throughout the transition to adult care. METHODS: Individuals in their last year of pediatric care (CC group, n = 51) and individuals lost to follow-up in the transfer to adult care ("lapsed care" [LC] group, n = 24) were followed prospectively for 12 months. All participants were provided developmentally tailored diabetes education, case management, and clinical care through a structured transition program. RESULTS: At baseline, LC participants reported lapses in care of 11.6 months. Compared with CC participants, they had higher hemoglobin A1C (A1C; p = .005), depressive symptoms (p = .05), incidence of severe hypoglycemia (p = .005), and emergency department visits (p = .004). At 12-month follow-up, CC and LC participants did not differ on the number of diabetes care visits (p = .23), severe hypoglycemia (no events), or emergency department visits (p = .22). Both groups' A1C improved during the study period (CC: p = .03; LC: p = .02). LC participants' depressive symptoms remained elevated (p = .10), and they reported a decline in life satisfaction (p = .007). There was greater loss to follow-up in the LC group (p = .04). CONCLUSIONS: Our study suggests that, for young adults with a history of lapses in care, a structured transition program is effective in lowering A1C, reducing severe hypoglycemia and emergency department utilization, and improving uptake of routine diabetes care. Loss to follow-up and psychosocial concerns remain significant challenges in this population.

Let's Empower and Prepare (LEAP): Evaluation of a Structured Transition Program for Young Adults With Type 1 Diabetes.

OBJECTIVE: To evaluate the efficacy of a structured transition program compared with usual care in improving routine follow-up, clinical, and psychosocial outcomes among young adults with type 1 diabetes. RESEARCH DESIGN AND METHODS: Eighty-one young adults in their last year of pediatric care were recruited from three clinics. Intervention group (IG) participants (n = 51) received a structured transition program incorporating tailored diabetes education, case management, group education classes, and access to a newly developed young adult diabetes clinic and transition website. Control group (CG) participants (n = 30) received usual care. The primary outcome was the number of routine clinic visits. Secondary outcomes included glycemic control, hypoglycemia, health care use, and psychosocial well-being. Assessments were conducted at baseline, and 6 and 12 months. RESULTS: Limitations in CG follow-up prevented direct comparisons of adult care visits; however, at the 12-month follow-up among IG participants discharged from pediatric care (n = 32), 78% had one or more adult visits. Among IG participants, the total number of clinic visits did not differ between those who transitioned and those who remained in pediatric care (3.0 ± 1.24 vs. 3.11 ± 0.94, P = 0.74). IG compared with CG participants had improved glycemic control (-0.40 ± 1.16% vs. 0.42 ± 1.51% [4.4 ± 12.7 mmol/mol vs. 4.6 ± 16.5 mmol/mol], P = 0.01), incidence of severe hypoglycemia (0.0% vs. 16%, P = 0.02), and global well-being (P = 0.02) at 12 months. CONCLUSIONS: A structured transition program was successful in facilitating transition to adult care without a decrease in clinical follow-up. Compared with usual care, the transition program facilitated improvements in glycemic control, hypoglycemia, and psychosocial well-being.

Impact of intensive lifestyle intervention on depression and health-related quality of life in type 2 diabetes: the Look AHEAD Trial.

OBJECTIVE: We examined the effects of an intensive lifestyle intervention (ILI), compared with a diabetes support and education (DSE) control intervention, on long-term changes in depression symptoms, antidepressant medication (ADM) use, and health-related quality of life (HRQoL) in overweight/obese individuals with type 2 diabetes. RESEARCH DESIGN AND METHODS: Look AHEAD was a multisite randomized controlled trial of 5,145 overweight/obese participants assigned to ILI (designed to produce weight loss) or DSE and followed for a median of 9.6 years. The Beck Depression Inventory (BDI) was administered at baseline, annually at years 1-4, and again at year 8. Mean BDI scores and incidence of BDI scores ≥10, indicative of likely mild or greater depression, were examined. Annually through year 10, participants reported their ADM use and completed the Medical Outcomes Study Short Form 36 (SF-36) questionnaire, which yields physical component summary (PCS) and mental component summary (MCS) scores. RESULTS: ILI significantly reduced the incidence of mild or greater depression symptoms (BDI scores ≥10) compared with DSE (hazard ratio [HR] = 0.85; 95% CI 0.75-0.97; P = 0.0145). Although SF-36 PCS scores worsened over time in both groups, ILI participants reported better physical function than DSE throughout the first 8 years (all P values <0.01). There were no significant differences between treatment arms in the proportion of participants who used ADMs or in SF-36 MCS scores. CONCLUSIONS: ILI for overweight/obese patients with type 2 diabetes may reduce the risk of developing clinically significant symptoms of depression and preserve physical HRQoL. These findings should be considered when evaluating the potential benefits of ILIs.

Continuous glucose monitoring pilot in low-income type 1 diabetes patients.

BACKGROUND: Continuous glucose monitoring (CGM) has been shown to be a valuable tool to improve glycemic control in patients with diabetes. The objective of this pilot study was to develop and implement CGM in an existing diabetes clinic for low-income patients on multiple daily injections. SUBJECTS AND METHODS: This was a single-center, prospective, randomized controlled, crossover pilot study. Initial focus groups were held to create low-literacy, Spanish and English guides to the use of carbohydrate counting and CGM. These tools were implemented to train participants on carbohydrate counting and insulin adjustments participants. Subjects were then randomized to start in Group A (CGM) or Group B (self-monitoring blood glucose and then switched after 28 weeks). Hemoglobin A1c (HbA1c) was obtained at baseline and at the end of both study phases. RESULTS: Twenty-five economically challenged, primarily Latino participants with minimal prior education on intensive diabetes management completed the study. No significant reduction in HbA1c or decrease in time spent in parameters of low and high blood glucose was shown. However, eighty percent of participants who completed the study wanted to continue to use CGM once the research study was over. The participants also felt that the CGM made adjusting insulin easier. CONCLUSIONS: CGM can be implemented in patients from a low-income public clinic; however, HbA1c reduction was not achieved. Given the underlying lack of baseline self-management knowledge, a longer trial might be necessary to see benefit with CGM in this population.

The role of farmers' markets in two low income, urban communities.

UNLABELLED: To collect consumer demographics, utilization, satisfaction, and eating and physical activity behavior information from customers using two newly established farmers' markets in low income urban communities in East and South Los Angeles. From April 1, 2007 through June 3, 2009, farmers' market customers completed a short, anonymous survey. The data analysis included a descriptive analysis of key variables and examined the number of new and repeat customers over time to track the rate of farmers' market use over time. SETTING: The East Los Angeles Farmers' Market and the Watts Healthy Farmers' Market. SUBJECTS: 415 farmers' market customers from East Los Angeles and 1,374 from South Los Angeles. The demographic profile of farmers' market consumers were primarily Latina women earning less than $22,000 per year with less than 12 years of education who reported some level of food insecurity. Most customers lived within 4 miles of the markets with repeat customers shopping twice a month or more. Overall, customers reported high satisfaction with the farmers' markets in each community and the majority reported positive changes in physical activity and eating behaviors since using the market. Many consumers reported they wanted to see additional items sold at the market, including prepared foods, non-food items and other products not allowed to be sold at certified farmers' markets.

Clinical and behavioral correlates of achieving and maintaining glycemic targets in an underserved population with type 2 diabetes.

OBJECTIVE: In an underserved Latino area, we established a disease-management program and proved its effectiveness. However, many patients still remained above target. This study was designed to evaluate which factors are associated with reaching program goals. RESEARCH DESIGN AND METHODS: This was a randomized, prospective, observational study in which patients enrolled in our program were followed for 2 years with outcomes, measures, and questionnaires assessed at baseline and at 6, 12, and 24 months. RESULTS: Overall, A1C fell by 1%. Adherence to medication was the strongest predictor of reaching the target A1C of <8%; baseline A1C was also predictive. Knowledge scores increased in those who reached target, but the measures of self-efficacy and empowerment did not change for either group. CONCLUSIONS: Diabetes management is effective in a lower-income Latino population. However, adherence was suboptimal even when medications were provided on-site for free. Further research into barriers associated with medication adherence is needed.

Food and park environments: neighborhood-level risks for childhood obesity in east Los Angeles.

PURPOSE: The rapid increase in obesity over the past two decades suggests that behavioral and environmental influences, including poor nutrition and physical inactivity, are fueling what is now widely recognized as a public health crisis. Yet, limited research has been conducted to examine how environmental factors, such as neighborhood-level characteristics, may be associated with increased risk for obesity. METHODS: Community-level risk associated with childhood obesity was examined in East Los Angeles, a community with one of the highest rates of childhood obesity in Los Angeles by triangulating: 1) spatial data for the number and location of food establishments relative to the location of schools; 2) observations regarding the availability and quality of fruits and vegetables in local grocery stores; and 3) observations regarding the quality and utilization of local parks. RESULTS: The findings revealed that there were 190 food outlets in the study community, of which 93 (49%) were fast-food restaurants. Of the fast-food restaurants, 63% were within walking distance of a school. In contrast, there were 62 grocery stores, of which only 18% sold fresh fruits and/or vegetables of good quality. Of the stores that did sell fruits and/or vegetables, only four were within walking distance of a school. Although well maintained, the five parks in this community accounted for only 37.28 acres, or 0.543 acres per 1000 residents. CONCLUSIONS: These findings suggest that children have easy access to fast food, and limited access to both healthy food options and parks in which to engage in physical fitness activities. This was particularly true in areas around schools. The implications for these findings with regards to policy-related prevention and future research are discussed.