Evaluation of a digital diabetes prevention program adapted for the Medicaid population: Study design and methods for a non-randomized, controlled trial.
ABSTRACT: Previous studies have shown that lifestyle modification can successfully prevent or delay development of type 2 diabetes. This trial aimed to test if an underserved, low-income population would engage in a digital diabetes prevention program and successfully achieve lifestyle changes to reduce their risk of type 2 diabetes. Participants were recruited from three health care facilities serving low-income populations. The inclusion criteria were: a recent blood test indicating prediabetes, body mass index (BMI)?>?24?kg/m2, age 18-75 years, not pregnant, not insured, Medicaid insured or Medicaid-eligible, internet or smartphone access, and comfort reading and writing in English or Spanish. A total of 230 participants were enrolled and started the intervention. Participants' average age was 48 years, average BMI?=?34.8, average initial HbA1c?=?5.8, 81% were female, and 45% were Spanish speaking. Eighty percent had Medicaid insurance, 18% were uninsured, and 2% were insured by a medical safety net plan. Participants completed a health assessment including measured anthropometrics, HbA1c test, and self-report questionnaires at baseline, 6 and 12 months. The 52-week digital diabetes prevention program included weekly educational curriculum, human health coaching, connected tracking tools, and peer support from a virtual group. Qualitative data on implementation was collected with semi-structured interviews with key informants to understand the barriers, keys to success, and best practices in the adoption of the program within the clinical setting. This paper describes the study design and methodology of a digital diabetes prevention program and early lessons learned related to recruitment, enrollment, and data collection.
Project description:BACKGROUND:Diabetes is a global epidemic affecting approximately 30 million people in the United States. The World Health Organization recommends using technology and telecommunications to improve health care delivery and disease management. The Livongo for Diabetes Program offers a remote monitoring technology with Certified Diabetes Educator outreach. OBJECTIVE:The purpose of this study was to examine health outcomes measured by changes in HbA1c, in time in target blood glucose range, and in depression symptoms for patients enrolled in a remote digital diabetes management program in a Diabetes Center of Excellence setting. METHODS:The impact of the Livongo for Diabetes program on hemoglobin A1c (HbA1c), blood glucose ranges, and depression screening survey results (Patient Health Questionnaire-2 [PHQ-2]) were assessed over 12 months in a prospective cohort recruited from the University of South Florida Health Diabetes Home for Healthy Living. Any patient ?18 years old with a diagnosis of diabetes was approached for voluntary inclusion into the program. The analysis was a pre-post design for those members enrolled in the study. Data was collected at outpatient clinic visits and remotely through the Livongo glucose meter. RESULTS:A total of 86 adults were enrolled into the Livongo for Diabetes program, with 49% (42/86) female, an average age of 50 (SD 15) years, 56% (48/86) with type 2 diabetes mellitus, and 69% (59/86) with insulin use. The mean HbA1c drop amongst the group was 0.66% (P=.17), with all participants showing a decline in HbA1c at 12 months. A 17% decrease of blood glucose checks <70 mg/dL occurred concurrently. Participants with type 2 diabetes not using insulin had blood glucose values within target range (70-180 mg/dL) 89% of the time. Participants with type 2 diabetes using insulin were in target range 68% of the time, and type 1 diabetes 58% of the time. Average PHQ-2 scores decreased by 0.56 points during the study period. CONCLUSIONS:Participants provided with a cellular-enabled blood glucose meter with real-time feedback and access to coaching from a certified diabetes educator in an outpatient clinical setting experienced improved mean glucose values and fewer episodes of hypoglycemia relative to the start of the program.
Project description:INTRODUCTION:We examined the effects of a digitally delivered, type 2 diabetes mellitus prevention program (DPP) for a low-income population. METHODS:We conducted a nonrandomized clinical trial with matched controls. The intervention group was offered a digital DPP, a web-based and mobile-based program including 52 weeks of participation in an educational curriculum, health coaching, and peer support. RESULTS:A total of 227 participants enrolled. At baseline, 34.6 was the mean body mass index, and 5.8 was the mean HbA1c. For the intervention group, mean weight loss was 4.4% at the 12-month follow-up. CONCLUSION:The modified DPP successfully engaged participants and resulted in weight loss. Low-income patients with prediabetes benefitted from a digitally delivered diabetes intervention. This prevention method should be accessible to a low-income population.
Project description:Understanding the relationships among diabetes, teeth present, and dental insurance is essential to improving primary and oral health care. Participants were older adults who attended senior centers in northern Manhattan (New York, N.Y.). Sociodemographic, health, and health care information were obtained via intake interviews, number of teeth present via clinical dental examinations, and glycemic status via measurement of glycosylated hemoglobin (HbA1c). Complete data on dental insurance coverage status for 785 participants were available for analysis (1,015 after multiple imputation). For participants with no dental insurance and any private/other dental insurance, number of teeth present is less for participants with diabetes than for participants without diabetes; however, for participants with Medicaid coverage only, the relationship is reversed. Potential explanations include the limited range of dental services covered under the Medicaid program, inadequate diabetes screening and monitoring of Medicaid recipients, and the poor oral and general health of Medicaid recipients.
Project description:To evaluate a digitally delivered, intensive behavioral counseling program for a workforce at risk for obesity-related chronic disease.Employees were offered a digital health program modeled after the diabetes prevention program (DPP). Annual workforce health assessments were used to examine changes in chronic disease risk factors between participants (n = 634) relative to a matched comparison group (n = 1268).Overall, employees were gaining an average of 3.5 pounds annually before program inception. Program engagement was positive; 83% completed the majority of the curriculum and 31% lost at least 5% of their starting weight. Compared with non-participating peers, participants demonstrated reduced weight, improved fasting blood glucose, and improved nutritional intake after a year.The digital health program was effective for engaging employees in health behavior change. Digital options facilitate widespread implementation.
Project description:<h4>Introduction</h4>The study details the experiences of Medicare, Medicaid and privately insured patients with diabetes in the United States by focusing on how these distinct populations perceive their disease and manage their treatment.<h4>Methods</h4>A national survey was fielded among a representative sample of 2,307 US adult diagnosed diabetes patients to investigate demographic, lifestyle, treatment, access to information, and socioeconomic status. This was achieved using a combination of telephone-based interviews and internet-based questionnaires administered via KnowledgePanel®, the only large-scale online panel based on a representative random sample of the US population.<h4>Results</h4>Patients with Medicaid-based insurance face significant differences in diagnosis, treatment and intensity of their diabetes as compared to their Medicare and privately insured counterparts. Medicaid patients develop diabetes at an earlier age with an increased level of severity, and face significant socioeconomic concerns. Medicaid patients also have different health information seeking preferences than their counterparts, impacted by technology use patterns and education preferences. All groups report challenges in paying for their diabetes care, though cost-sharing requirements are relatively low.<h4>Conclusions</h4>Significant variation in experience between Medicaid, Medicare, and privately insured patients can inform disease management and patient engagement strategies. Payers, clinicians and public health agencies can leverage these findings to design initiatives more effectively and understand how intergroup variability impacts program uptake and disease outcomes.
Project description:OBJECTIVE:Type 2 diabetes is growing in epidemic proportions and disproportionately affects lower-income, diverse communities. Text messaging may provide one of the most rapid methods to overcome the "digital divide" to improve care. RESEARCH DESIGN AND METHODS:A randomized, nonblinded, parallel-groups clinical trial design allocated N = 126 low-income, Hispanic participants with poorly controlled type 2 diabetes to receive the Dulce Digital intervention or usual care (UC). Dulce Digital participants received up to three motivational, educational, and/or call-to-action text messages per day over 6 months. The primary outcome was HbA1c; lipids, blood pressure, and BMI were secondary outcomes. Satisfaction and acceptability were evaluated via focus groups and self-report survey items. RESULTS:The majority of patients were middle-aged (mean age 48.43 years, SD 9.80), female (75%), born in Mexico (91%), and uninsured (75%) and reported less than a ninth-grade education level (73%) and mean baseline HbA1c 9.5% (80 mmol/mol), SD 1.3, and fasting plasma glucose 187.17 mg/dL, SD 64.75. A statistically significant time-by-group interaction effect indicated that the Dulce Digital group achieved a significantly greater reduction in HbA1c over time compared with UC (P = 0.03). No statistically significant effects were observed for secondary clinical indicators. The number of blood glucose values texted in by participants was a statistically significant predictor of month 6 HbA1c (P < 0.05). Satisfaction and acceptability ratings for the Dulce Digital intervention were high. CONCLUSIONS:Use of a simple, low-cost text messaging program was found to be highly acceptable in this sample of high-risk, Hispanic individuals with type 2 diabetes and resulted in greater improvement in glycemic control compared with UC.
Project description:Background:Social media can effectively mediate digital health interventions and thus, overcome barriers associated with face-to-face interaction. Objective:To assess the impact of patient-centered diabetes education program administered through WhatsApp on glycosylated hemoglobin (HbA1c) values, assess the correlation, if any, between health literacy and numeracy on intervention outcomes. Methods:During an 'intervention phase' spread over six months, target diabetic patients (N=109) received structured education through WhatsApp as per the American Association of Diabetes Educators Self-Care Behaviors recommendations. The control group with an equal number of participants received 'usual care' provided by health professionals void of the social media intervention. Changes in HbA1c levels were recorded thrice (at baseline, 3 and 6 months) for the test group and twice (baseline and 6 months) for the control group. Change in HbA1c values were compared and statistical significance was defined at p<0.05. Baseline health literacy and diabetes numeracy were assessed for both groups (N=218) using the Literacy Assessment for Diabetes (LAD), and the Diabetes Numeracy Test (DNT), respectively, and values were correlated with HbA1c change p<0.05. Participants' satisfaction with the intervention was also assessed. Results:The average age of respondents was 41.98 (SD 15.05) years, with a diabetes history of 10.2 (SD 8.5) years. At baseline, the average HbA1c in the control and test groups were 8.4 (SD 1.06) and 8.5 (SD 1.29), respectively. After six months, a significant drop in HbA1c value was noticed in intervention group (7.7; SD 1.35; p= 0.001); with no significance in the control group (8.4; SD 1.32; p=0.032, paired t-test). Moreover, the reduction in HbA1c was more in the test group (0.7%) than the control group (0.1%) with a difference of 0.6% which is considered clinically significant. There was no significant correlation between LAD score and HbA1c at baseline (r=-0.203, p=0.064), 3 months (r=-0.123, p=0.266) and 6 months (r=-0.106, p= 0.337) Pearson correlation. A similar result was observed with DNT, where DNT score and HbA1c at baseline, 3 months and 6 months showed no correlation (r=0.112, 0.959 and 0.886; respectively) with HbA1c levels. Eighty percent of the respondents found the social media intervention 'beneficial' and suggested it be used long term. Conclusions:Diabetes education via WhatsApp showed promising outcomes regardless of the level of patients' health literacy or numeracy.
Project description:Promotora Effectiveness Versus Metformin Trial (PREVENT-DM) is a randomized comparative effectiveness trial of a lifestyle intervention based on the Diabetes Prevention Program delivered by community health workers (or promotoras), metformin, and standard care. Eligibility criteria are Hispanic ethnicity, female sex, age ? 20 years, fluent Spanish-speaking status, BMI ? 23 kg/m(2), and prediabetes. We enrolled 92 participants and randomized them to one of the following three groups: standard care, DPP-based lifestyle intervention, or metformin. The primary outcome of the trial is the 12-month difference in weight between groups. Secondary outcomes include the following cardiometabolic markers: BMI, waist circumference, blood pressure, and fasting plasma glucose, hemoglobin A1C (HbA1c), total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, and insulin. PREVENT-DM participants are socioeconomically disadvantaged Latinas with a mean annual household income of $15,527 ± 9922 and educational attainment of 9.7 ± 3.6 years. Eighty-six percent of participants are foreign born, 20% have a prior history of gestational diabetes, and 71% have a first-degree relative with diagnosed diabetes. At baseline, PREVENT-DM participants had a mean age of 45.1 ± 12.5 years, weight of 178.8 ± 39.3 lbs, BMI of 33.3 ± 6.5 kg/m(2), HbA1c of 5.9 ± 0.2%, and waist circumference of 97.4 ± 11.1cm. Mean baseline levels of other cardiometabolic markers were normal. The PREVENT-DM study successfully recruited and randomized an understudied population of Latinas with prediabetes. This trial will be the first U.S. study to test the comparative effectiveness of metformin and lifestyle intervention versus standard care among prediabetic adults in a "real-world" setting.
Project description:BACKGROUND:Lifestyle change interventions (LCI) for prevention of type 2 diabetes are covered by Medicare, but rarely by US Medicaid programs that constitute the largest public payer system in the USA. We estimate the long-term health and economic implications of implementing LCIs in state Medicaid programs. METHODS:We compared LCIs modeled after the intervention of the Diabetes Prevention Program versus routine care advice using a decision analytic simulation model and best available data from representative surveys, cohort studies, Medicaid claims data, and the published literature. Target population were non-disability-based adult Medicaid beneficiaries aged 19-64 years at high risk for type 2 diabetes (BMI ?25 kg/m2 and HbA1c ? 5.7% or fasting plasma glucose ? 110 mg/dl) from eight study states (Alabama, California, Connecticut, Florida, Iowa, Illinois, New York, Oklahoma) that represent around 50% of the US Medicaid population. Incremental cost-effectiveness ratios (ICERs) measured in cost per quality-adjusted life years (QALYs) gained, and population cost and health impact were modeled from a healthcare system perspective and a narrow Medicaid perspective. RESULTS:In the eight selected study states, 1.9 million or 18% of non-disability-based adult Medicaid beneficiaries would belong to the eligible high-risk target population - 66% of them Hispanics or non-Hispanic black. In the base-case analysis, the aggregated 5- and 10-year ICERs are US$226 k/QALY and US$34 k/QALY; over 25 years, the intervention dominates routine care. The 5-, 10-, and 25-year probabilities that the ICERs are below US$50 k (US$100 k)/QALY are 6% (15%), 59% (82%) and 96% (100%). From a healthcare system perspective, initial program investments of US$800 per person would be offset after 13 years and translate to US$548 of savings after 25 years. With a 20% LCI uptake in eligible beneficiaries, this would translate to upfront costs of US$300 million, prevent 260 thousand years of diabetes and save US$205 million over a 25-year time horizon. Cost savings from a narrow Medicaid perspective would be much smaller. Minorities and low-income groups would over-proportionally benefit from LCIs in Medicaid, but the impact on population health and health equity would be marginal. CONCLUSIONS:In the long-term, investments in LCIs for Medicaid beneficiaries are likely to improve health and to decrease healthcare expenditures. However, population health and health equity impact would be low and healthcare expenditure savings from a narrow Medicaid perspective would be much smaller than from a healthcare system perspective.
Project description:OBJECTIVE:We examined the effects of metformin on diabetes prevention and the subgroups that benefited most over 15 years in the Diabetes Prevention Program (DPP) and its follow-up, the Diabetes Prevention Program Outcomes Study (DPPOS). RESEARCH DESIGN AND METHODS:During the DPP (1996-2001), adults at high risk of developing diabetes were randomly assigned to masked placebo (n = 1,082) or metformin 850 mg twice daily (n = 1,073). Participants originally assigned to metformin continued to receive metformin, unmasked, in the DPPOS (2002-present). Ascertainment of diabetes development was based on fasting or 2-h glucose levels after an oral glucose tolerance test or on HbA1c. Reduction in diabetes incidence with metformin was compared with placebo in subgroups by hazard ratio (HR) and rate differences (RDs). RESULTS:During 15 years of postrandomization follow-up, metformin reduced the incidence (by HR) of diabetes compared to placebo by 17% or 36% based on glucose or HbA1c levels, respectively. Metformin's effect on the development of glucose-defined diabetes was greater for women with a history of prior gestational diabetes mellitus (GDM) (HR 0.59, RD -4.57 cases/100 person-years) compared with parous women without GDM (HR 0.94, RD -0.38 cases/100 person-years [interaction P = 0.03 for HR, P = 0.01 for RD]). Metformin also had greater effects, by HR and RD, at higher baseline fasting glucose levels. With diabetes development based on HbA1c, metformin was more effective in subjects with higher baseline HbA1c by RD, with metformin RD -1.03 cases/100 person-years with baseline HbA1c <6.0% (42 mmol/mol) and -3.88 cases/100 person-years with 6.0-6.4% (P = 0.0001). CONCLUSIONS:Metformin reduces the development of diabetes over 15 years. The subsets that benefitted the most include subjects with higher baseline fasting glucose or HbA1c and women with a history of GDM.