Personalized Medicine for Diabetes: The Prevention of Type 2 Diabetes: An Overview

Type 2 diabetes mellitus is one of the major public health threats in the United States today, reaching epidemic rates. Epidemiological evidence suggests a strong link between obesity and the risk of developing diabetes. Increasing evidence demonstrates that lifestyle interventions can significantly delay or possibly prevent the onset of type 2 diabetes in persons with increased risk. Despite these findings, there remain important barriers to the translation of this research to the public health. These include identifying persons with an increased risk for developing the disease and the lack of easily accessible, cost-effective intervention programs. At least one study, however, has effectively implemented an evidenced-based intervention in community settings, suggesting that it may be possible to develop a model for the national scalability of primary prevention in the United States

Psychometric Properties of the Healthful Eating Belief Scales for Persons at Risk of Diabetes

Objective: To examine the validity and reliability of Theory of Planned Behavior (TPB) scales for healthful eating for persons at risk for diabetes. Design: Cross-sectional, using a self-administered questionnaire. Setting: Community in the Midwest. Participants: 106 adults who self-identified based on one or more American Diabetes Association diabetes risks. Variables Measured: Behavioral, normative, and control beliefs; and attitude, subjective norm, perceived behavioral control, and intention to eat a healthful diet. Analysis: Construct validity was assessed with factor analyses and measurement and structural models using structural equation modeling. Reliability of the scales was assessed with Cronbach alpha and a 2-month test- retest. Results: Factor analysis loadings were greater than .37. Cronbach alphas for the behavioral, normative, and control belief scales were .80, .91, and .84, respectively. The measurement model revealed that the measures were significant estimates for the TPB constructs, and they fit well as indirect measures of attitude, subjective norm, and perceived behavioral control in predicting intention to eat a healthful diet. Test-retest revealed 2- month stability of the scales. Conclusions and Implications: Scales for measuring TPB behavioral, normative, and control beliefs were valid and reliable for use with adults at risk for diabetes. Further examination with minority persons is warranted

Physical Activity Belief Scales for Diabetes Risk: Development and Psychometric Testing

This article describes the development and psychometric evaluation of behavioral belief, normative belief, and control belief scales, derived from the theory of planned behavior to predict physical activity intentions of persons at risk for diabetes. In Study 1, belief statements from interviews were categorized, ranked, and evaluated for item construction. Content validity was established by 96. 1 % agreement among a five-member expert panel. In Study 2, items developed from the belief statements were administered to 106 adults at risk for diabetes. Psychometric analyses provided evidence of construct validity and reliability of the three scales. Internal consistency was sufficient (α = .76-.95), and test-retest evaluations indicated scale stability (r = .79- .91). Factor analyses and confirmatory factor analysis using structural equation modeling provided evidence that the items were appropriately grouped under each construct. Researchers and practitioners can use these measures to assess behavioral, normative, and control beliefs about physical activity among persons at risk for diabetes

The HealthPia GlucoPack™ Diabetes Phone: A Usability Study

This is a copy of an article published in Diabetes Technology & Therapeutics copyright Mary Ann Liebert, Inc.; Diabetes Technology & Therapeutics is available online at: http://online.liebertpub.com.Background: Type I diabetes is a common chronic disease of childhood. Both the growing influence of peers and the shifting away from parental influence have been implicated as prime elements contributing to poor glycemic outcomes in adolescents. Mobile technology that can be directed towards providing self-management support and modifying potentially negative child parent interaction holds promise to improve control in adolescents with diabetes. Methods: HealthPia, Inc. (Palisades Park, NJ) has developed a prototype system, the HealthPia GlucoPack™ Diabetes Monitoring System, which integrates a small blood glucose monitoring device into the battery pack of a cell phone. A pilot study used mixed quantitative and qualitative methods to evaluate user satisfaction with the integrated system, including the potential of the device to transmit self-monitoring data to a website for review and analysis by clinicians, parents, and patients. Results: Adolescents in our study liked the integration of the two technologies and agreed that the glucometer was easy to use and that the tool was useful in the management of their diabetes. Conclusions: Future work will focus on the utilization of the diabetes phone as a component of a care delivery system for adolescents with diabetes, including involvement of the health care team and enhancement of the web services that support the use of the phone

Analytical Comparison of the Effectiveness of the Diabetes Prevention Program and Weight Watchers as media to prevent Type II Diabetes via Weight Loss in Different Age Categories

poster abstractType II Diabetes is a condition in which the body does not utilize insulin properly and causes detrimental symptoms such as glucose build up in the blood, overflown into the urine and passed out of the body without fulfilling the body’s main source of fuel. The Diabetes Prevention Program (DPP) is a multi-center clinical research study aimed to discover modest weight loss methods compared to oral medication (Glucophage) which prevents diabetes. Subsequently, the Health Information and Translational Sciences department at Indiana University School of Medicine uses Weight Watchers, a weight loss program, for participants at risk for Type II Diabetes (pre-diabetic) to monitor their weight and glucose levels. Both programs are investigating ways to justify the same hypothesis using different methods. Both studies aspire to determine the most affective ways for people to lose weight in order to prevent Type II Diabetes. The DPP was an efficacy trial to establish a correlation between weight loss and the risk of Type II Diabetes. Although the DPP successfully proved their hypothesis, the Weight Watchers study provides another approach in the mission of diabetes prevention. By analyzing six months of archived physical measurements data for the Diabetes Prevention Program study and the Weight Watchers study, one can determine how affective each program is in preventing weight loss depending on the age classification. The age groups are compared in fifteen-year intervals for both programs. Although both programs are successful in their mission, the conclusion of which program is more affective is still under continued study

Center for Pediatric Obesity and Diabetes Prevention Research

poster abstractBackground To facilitate both research and treatment of obesity in youth who are at especially high risk for diabetes, we have created the Center for Pediatric Obesity and Diabetes Prevention Research. The mission of the center is to advance the health of vulnerable populations through obesity and diabetes prevention research focusing on mechanisms of progression from obesity to type 2 diabetes, defining best practices for obesity/diabetes prevention among youth, and cost-effective translation of the research to the community. Specific Aims 1. To promote the clinical investigation of pathophysiologic mechanisms, diagnosis, and primary prevention of type 2 diabetes among vulnerable youth 2. Foster collaboration and facilitate interdisciplinary research between investigators interested in childhood obesity and diabetes prevention 3. Participate in community-based diabetes prevention research Key Ongoing Collaborative Research Projects Youth Diabetes Prevention Clinic (YDPC) – Patient-Centered Outcomes Project This program is designed to evaluate and assess the needs of adolescents (ages 10 – 21) who have evidence of prediabetes. Our goal is to successfully intervene in the trajectory toward the development of diabetes, and to promote healthy weight-control and improved well-being through an individualized treatment plan. Not only has this allowed us to address a significant unmet clinical need, but also to advance pediatric obesity patient-centered outcomes research and comparative effectiveness research in adolescent obesity / diabetes prevention. Dietary Intervention for Glucose Intolerance in Teens (DIG-IT Study) The objective of this study is to determine the impact on glycemic control, in adolescents who have prediabetes, of an individually-tailored wellness coaching strategy used to modify lifestyle habits. Additionally, the study aims to identify lifestyle factors that drive glycemic control, independent of changes in weight. We are conducting this study in in the Youth Diabetes Prevention Clinic via a collaboration with Dr. Gletsu-Miller (Purdue University). ENCOURAGE Healthy Families Study This is a randomized trial evaluating the comparative effectiveness and costs of an adaptation of the Diabetes Prevention Program (DPP) directed at mothers and their children. The intervention is a group based lifestyle program which we developed and implemented in partnership with the YMCA. We are comparing the ENCOURAGE intervention targeted to 1) mothers who have had gestational diabetes or prediabetes, and 2) mothers who have had GDM or prediabetes along with their school-aged children

Using a cell phone-based glucose monitoring system for adolescent diabetes management

INTRODUCTION: Mobile technology may be useful in addressing several issues in adolescent diabetes management. PURPOSE: To assess the feasibility and acceptability of a cell phone glucose monitoring system for adolescents with type 1 diabetes and their parents. METHODS: The authors recruited patients with type 1 diabetes who had been diagnosed for at least 1 year. Each adolescent used the system for 6 months, filling out surveys every 3 months to measure their usability and satisfaction with the cell phone glucose monitoring system, as well as how use of the system might affect quality of family functioning and diabetes management. RESULTS: Adolescents reported positive feelings about the technology and the service, even though a concerning number of them had significant technical issues that affected continued use of the device. Nearly all thought that the clinic involvement in monitoring testing behavior was quite acceptable. The use of the Glucophone™ did not, however, significantly change the quality of life of the adolescents, their level of conflict with their parents, their reported self-management of diabetes, or their average glycemic control within the short time frame of the study. CONCLUSIONS: As a feasibility study of the technology, this work was successful in demonstrating that cell phone glucose monitoring technology can be used in an adolescent population to track and assist in self-monitoring behavior. The authors speculate that explicitly attempting to change behavior, perhaps with the use of behavioral contracts, would enhance the technology's ability to improve outcomes

Improving Medication Adherence for Chronic Disease Using Integrated e-Technologies

Diabetes mellitus (DM) is a chronic disease affecting more than 285 people worldwide and the fourth leading cause of death. Increasing evidence suggests that many DM patients have poor adherence with prescribed medication therapies, impacting clinical outcomes. Patients' barriers to medication adherence and the extent to which barriers contribute to poor outcomes, however, are not routinely assessed. We designed a dashboard for an electronic health record system to integrate DM disease and medication data, including patient-reported barriers to adherence. Processes to support routine capture of data from patients are also being explored. The dashboard is being evaluated at multiple ambulatory clinics to examine whether integrated electronic tools can support patient-centered decision-making processes involving complex medication regimens for DM and other chronic diseases

Validation of a Scale to Measure Patient-Perceived Barriers to Medication Use

AIMS: Medication adherence may explain why patients show very different clinical outcomes. Previous assessments of adherence have used refill rates and pill counts. Few studies have investigated patient-identified barriers to using medications as prescribed. This is particularly true for persons with diabetes, most of whom are using poly-pharmacy regimens. We created a questionnaire to measure patient perceptions of barriers to medication adherence (PBMA) targeting a predominately low income, inner-city minority population. METHODS: Twenty items (Likert scale) leading with "I sometimes don't take my diabetes medicines because..." were developed from 5 focus groups (N=48). A questionnaire including these items was mailed to 1000 patients who have diabetes. RESULTS: Using data from 267 respondents (Mean age=58, 74%female, 43% non-Hispanic Caucasian, 77% income<$15,000), exploratory factor analyses with varimax rotation identified 5 factors, that may contribute to poor medication adherence: personal access to medications (F1); communication with providers (F2); understanding or appropriately following the prescribed regimen (F3); side effects (F4) and system factors that inhibited access to medication (F5). Cronbach alphas ranged from .73 to .83 for the five factors and was .92 for total scale score. No relationships were found between total scores and gender, race, or income. Greater perception of barriers was significantly (p<0.01) associated with being younger (r= -0.21), being bothered more by physical (r= -0.40) and emotional side effects (r= 0.43), and less satisfaction with control of blood sugar by diabetes medications (r= 0.45). CONCLUSIONS: This instrument is reliable, factorially valid, and consistent with clinical observation regarding factors known to be associated with patient medication adherence. Although study participants were patients with diabetes, the PBMA may be applicable to other therapeutic areas

Translating the Diabetes Prevention Program into the Community The DEPLOY Pilot Study

Background The Diabetes Prevention Program (DPP) found that an intensive lifestyle intervention can reduce the development of diabetes by more than half in adults with prediabetes, but there is little information about the feasibility of offering such an intervention in community settings. This study evaluated the delivery of a group-based DPP lifestyle intervention in partnership with the YMCA. Methods This pilot cluster-randomized trial was designed to compare group-based DPP lifestyle intervention delivery by the YMCA to brief counseling alone (control) in adults who attended a diabetes risk-screening event at one of two semi-urban YMCA facilities and who had a BMI ≥24 kg/m2, ≥2 diabetes risk factors, and a random capillary blood glucose of 110–199 mg/dL. Multivariate regression was used to compare between-group differences in changes in body weight, blood pressures, HbA1c, total cholesterol, and HDL-cholesterol after 6 and 12 months. Results Among 92 participants, controls were more often women (61% vs 50%) and of nonwhite race (29% vs 7%). After 6 months, body weight decreased by 6.0% (95% CI=4.7, 7.3) in intervention participants and 2.0% (95% CI=0.6, 3.3) in controls (p<0.001; difference between groups). Intervention participants also had greater changes in total cholesterol (–22 mg/dL vs +6 mg/dL controls; p<0.001). These differences were sustained after 12 months, and adjustment for differences in race and gender did not alter these findings. With only two matched YMCA sites, it was not possible to adjust for potential clustering by site. Conclusions The YMCA may be a promising channel for wide-scale dissemination of a low-cost approach to lifestyle diabetes prevention