Dulce Digital: An mHealth SMS-Based Intervention Improves Glycemic Control in Hispanics With Type 2 Diabetes.
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ABSTRACT: 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.
SUBMITTER: Fortmann AL
PROVIDER: S-EPMC5606313 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Type 2 diabetes disproportionately impacts ethnic minorities and individuals from low socioeconomic status. Diabetes self-management education and support has been shown to improve clinical outcomes in these populations, and mobile health (mHealth) interventions can reduce barriers to access. Dulce Digital-Me (DD-Me) was developed to integrate adaptive mHealth technologies to enhance self-management and reduce disparities in the high-risk, underserved Hispanic population. The objective of the present study was to evaluate reach, adoption, and implementation of an mHealth diabetes self-management education and support intervention in this underrepresented population. The present analysis is a multimethod process evaluation using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The study was effective in reaching a sample that was representative of the intended population; only modest but significant differences were observed in sex and age. The DD-Me health coach (HC) cited several important facilitators of intervention adoption, including outreach frequency and personalization, and the automated HC report. Implementation fidelity was high, with participants receiving >90% of intended interventions. Participants who received DD-Me with support from a HC were most engaged, suggesting utility and acceptability of integrating HCs with mHealth interventions. Perceptions of implementation among study participants were positive and consistent across study arms. This evaluation revealed the target population was successfully reached and engaged in the digital health interventions, which was implemented with high fidelity. Further studies should evaluate the efficacy and maintenance of the study following the RE-AIM model to determine whether this intervention warrants expansion to additional settings and populations.
| S-EPMC10496430 | biostudies-literature
Project description:BackgroundBy 2034, the number of US individuals with diabetes is predicted to increase from 23.7 to 44.1 million, and annual diabetes-related spending is expected to grow from $113 to $336 billion. Up to 55% of US Hispanics born in the year 2000 are expected to develop diabetes during their lifetime. Poor healthcare access and cultural barriers prevent optimal care, adherence, and clinical benefit, placing Hispanics at disproportionate risk for costly diabetes complications. Mobile technology is increasingly prevalent in all populations and can circumvent such barriers. Our group developed Dulce Digital, an educational text messaging program that improved glycemic control relative to usual care. Dulce Digital-Me (DD-Me) has been tailored to a participant's individual needs with a greater focus on health behavior change.MethodsThis is a three-arm, parallel group, randomized trial with equal allocation ratio enrolling Hispanic adults with low income and poorly managed type 2 diabetes (N = 414) from a San Diego County Federally Qualified Health Center. Participants are randomized to receive Dulce Digital, Dulce Digital-Me-Automated, or Dulce Digital-Me-Telephonic. The DD-Me groups include Dulce Digital components plus personalized goal-setting and feedback delivered via algorithm-driven automated text messaging (DD-Me-Automated) or by the care team health coach (DD-Me-Telephonic) over a 12-month follow-up period. The study will examine the comparative effectiveness of the three groups in improving diabetes clinical control [HbA1c, primary outcome; low-density lipoprotein cholesterol (LDL-C), and systolic blood pressure (SBP)] and patient-provider communication and patient adherence (i.e., medication, self-management tasks) over 12 months and will examine cost-effectiveness of the three interventions.DiscussionOur comparative evaluation of three mHealth approaches will elucidate how technology can be integrated most effectively and efficiently within primary care-based chronic care model approaches to reduce diabetes disparities in Hispanics and will assess two modes of personalized messaging delivery (i.e., automated messaging vs. telephonic by health coach) to inform cost and acceptability.Trial registrationNCT03130699-All items from the WHO Trial Registration data set are available in https://clinicaltrials.gov/ct2/show/study/NCT03130699 .
| S-EPMC8796443 | biostudies-literature
Project description:BACKGROUND:Type 2 diabetes (T2D) is a major chronic condition requiring management through lifestyle changes and recommended health service visits. Mobile health (mHealth) is a promising tool to encourage self-management, but few studies have investigated the impact of mHealth on health care utilization. OBJECTIVE:The objective of this analysis was to determine the change in 2-year health service utilization and whether utilization explained a 1.9% absolute decrease in glycated hemoglobin (HbA1c) over 1-year in the Mobile Diabetes Intervention Study (MDIS). METHODS:We used commercial claims data from 2006 to 2010 linked to enrolled patients' medical chart data in 26 primary care practices in Maryland, USA. Secondary claims data analyses were available for 56% (92/163) of participants. In the primary MDIS study, physician practices were recruited and randomized to usual care and 1 of 3 increasingly complex interventions. Patients followed physician randomization assignment. The main variables in the analysis included health service utilization by type of service and change in HbA1c. The claims data was aggregated into 12 categories of utilization to assess change in 2-year health service usage, comparing rates of usage pre- and posttrial. We also examined whether utilization explained the 1.9% decrease in HbA1c over 1 year in the MDIS cluster randomized clinical trial. RESULTS:A significant group by time effect was observed in physician office visits, general practitioner visits, other outpatient services, prescription medications, and podiatrist visits. Physician office visits (P=.01) and general practitioner visits (P=.02) both decreased for all intervention groups during the study period, whereas prescription claims (P<.001) increased. The frequency of other outpatient services (P=.001) and podiatrist visits (P=.04) decreased for the control group and least complex intervention group but increased for the 2 most complex intervention groups. No significant effects of utilization were observed to explain the clinically significant change in HbA1c. CONCLUSIONS:Claims data analyses identified patterns of utilization relevant to mHealth interventions. Findings may encourage patients and health providers to discuss the utilization of treatment-recommended services, lab tests, and prescribed medications. TRIAL REGISTRATION:ClinicalTrials.gov NCT01107015; https://clinicaltrials.gov/ct2/show/NCT01107015 (Archived by Webcite at http://www.webcitation.org/72XgTaxIj).
| S-EPMC6231737 | biostudies-literature
Project description:ObjectiveTo evaluate the effectiveness of a weight loss intervention in Mongolian adults with newly diagnosed type 2 diabetes mellitus and with BMIs ≥ 25.0 kg/m2.MethodsEighty participants (33 men/47 women) aged 32-56 years old received education sessions to improve nutritional habits and increase physical activity. Participants were counselled in-person on two occasions with regular follow-up by phone to eat less (reduce calorie intake by 30-40% and consume fewer fatty foods), shift food intake to earlier in a day and increase physical activity such as walking, jogging, running and biking. Measurements were performed before and after the 6-month intervention.ResultsAfter 6 months, the average weight loss was 4.3 ± 4.7 kg, representing a 4.9 ± 5.4% reduction in body weight (p < 0.0001). Mean HbA1c decreased from 8.5 ± 2.7% to 6.0 ± 1.8% (p < 0.0001), and the percent of individuals with HbA1c in the diabetic range dropped from 76.3% to 27.5%. These changes were accompanied by marked improvements in cardiovascular risk factors, including total cholesterol (3.92 ± 1.02 to 3.13 ± 0.80 mmol/l; p < 0.0001) and triglycerides (2.11 ± 0.82 to 1.54 ± 0.51 mmol/l; p < 0.0001), and modest reductions in systolic and diastolic blood pressure (p < 0.05).ConclusionThe remarkable improvement in glycemic control and lipid profile in participants suggests that a lifestyle modification intervention targeting weight loss may be highly effective for early diabetes treatment and prevention in Mongolians.
| S-EPMC5043476 | biostudies-literature
Project description:BackgroundLimited access to mental health care services due to provider shortages, geographic limitations, and cost has driven the area of mobile health (mHealth) care to address these access gaps. Reports from the Cohen Veterans Network and National Council for Behavioral Health show that in states where mental health care is more accessible, 38% of people still do not receive the care they need. mHealth strategies help to provide care to individuals experiencing these barriers at lower cost and greater convenience, making mHealth a great resource to bridge the gaps.ObjectiveWe present a mixed methods study to evaluate user experiences with the mental mHealth service, Cope Notes. Specifically, we aimed to investigate the following research questions: How do users perceive the service in relation to stigma, impact of the intervention, and perceived usefulness? How do users rate the Cope Notes service and SMS text messaging along various dimensions of acceptability? What is the relationship between Cope Notes SMS text message ratings, user personality, and coping strategies? What are user perspectives of leveraging ubiquitous sensing technologies to improve delivery and provide tailored content?MethodsWe performed qualitative interviews with Cope Notes users (N=14) who have used the service for at least 30 days to evaluate their experiences and usefulness of the service. These interviews were coded by 2 raters (SLK and JL), and the interrater reliability was calculated with SPSS (IBM Corp) at 61.8%. In addition, participants completed quantitative measures, including a user experiences survey, personality inventory (Big Five Inventory-10), and coping assessment (Brief Coping Orientation to Problems Experienced).ResultsWe derived 7 themes from our qualitative interviews: Likes or Perceived Benefits, Dislikes or Limitations, Suggested Changes, Stigma or Help Seeking, Perceptions of Ubiquitous Sensing, Cultural Sensitivity, and Alternative mHealth Resources. Exploratory analyses between acceptability ratings of Cope Notes and personality factors showed statistically significant positive relationships between seeing oneself as someone who is generally trusting and acceptability items, the most significant being item 7 (I fully understood the sentiment behind Cope Notes Messages) with (rs(10)=0.82, P=.001). We also found statistically significant relationships between acceptability and Brief Coping Orientation to Problems Experienced items, with the strongest positive correlation between participants strongly endorsing coping by accepting the reality that an event has happened and acceptability item 7 (rs(8)=0.86, P=.001).ConclusionsOur study found that Cope Notes subscribers appreciate the service for reframing their mental wellness with statistically significant correlations between personality and acceptability of the service. We found that some users prefer a more personalized experience with neutral to positive reactions to a potential companion app that continuously monitors user behavior via smartphone sensors to provide just-in-time interventions when users need it most.
| S-EPMC9115655 | biostudies-literature
Project description:ObjectiveTo evaluate the effect of a culturally sensitive diabetes self-management education program that uses a low-cost, peer-educator format (Project Dulce) on glucose control and metabolic parameters in low-income Mexican Americans with type 2 diabetes.Research design and methodsA total of 207 Mexican-American patients recruited from federally funded community health centers in San Diego County with HbA(1c) >8% were randomly assigned to the Project Dulce peer intervention or continuation of standard diabetes care. The primary outcome of interest was HbA(1c).ResultsThe majority of subjects were born in Mexico, were female, were middle-aged, had less than an eighth-grade education, and had high baseline HbA(1c) levels. Significant time-by-group interaction effects for HbA(1c) (P = 0.02) and diastolic blood pressure (P = 0.04) indicated that the Project Dulce group exhibited greater improvement (i.e., decreases) across time. Within-group analyses showed that the intervention group exhibited significant improvements from baseline to month 4 in absolute levels of HbA(1c) (-1.7%, P = 0.001) and HDL cholesterol (+1.4 mg/dL, P = 0.01) and from baseline to month 10 in absolute levels of HbA(1c) (-1.5%, P = 0.01), total cholesterol (-7.2 mg/dL, P = 0.04), HDL cholesterol (+1.6 mg/dL, P = 0.01), and LDL cholesterol (-8.1 mg/dL, P = 0.02). No significant changes were noted in the control group.ConclusionsThis randomized trial, using the Project Dulce model of culturally sensitive, peer-led education, demonstrates improvement in glucose and metabolic control and suggests that this low-cost approach to self-management education for high-risk diabetic populations is effective.
| S-EPMC3161298 | biostudies-literature
Project description:OBJECTIVE:To assess the efficacy of a manualized occupational therapy (OT) intervention (Resilient, Empowered, Active Living with Diabetes [REAL Diabetes]) to improve glycemic control and psychosocial well-being among ethnically diverse young adults with low socioeconomic status (SES) who have type 1 or type 2 diabetes. RESEARCH DESIGN AND METHODS:Eighty-one young adults (age 22.6 ± 3.5 years; hemoglobin A1c [HbA1c] = 10.8%/95 mmol/mol ± 1.9%/20.8 mmol/mol) were randomly assigned to the REAL Diabetes intervention group (IG) or an attention control group (CG) over 6 months. IG participants received biweekly sessions guided by a manual composed of seven content modules; CG participants received standardized educational materials and biweekly phone calls. Blinded assessors collected data at baseline and 6 months. The primary outcome was HbA1c; secondary outcomes included diabetes self-care, diabetes-related quality of life (QOL), diabetes distress, depressive symptoms, and life satisfaction. Change scores were analyzed using Wilcoxon rank sum tests. RESULTS:Intent-to-treat analyses showed that IG participants showed significant improvement in HbA1c (-0.57%/6.2 mmol/mol vs. +0.36%/3.9 mmol/mol, P = 0.01), diabetes-related QOL (+0.7 vs. +0.15, P = 0.04), and habit strength for checking blood glucose (+3.9 vs. +1.7, P = 0.05) as compared with CG participants. There was no statistically significant effect modification by sex, ethnicity, diabetes type, recruitment site, or SES. No study-related serious adverse events were reported. CONCLUSIONS:The REAL Diabetes intervention improved blood glucose control and diabetes-related QOL among a typically hard-to-reach population, thus providing evidence that a structured OT intervention may be beneficial in improving both clinical and psychosocial outcomes among individuals with diabetes.
| S-EPMC5860833 | biostudies-literature
Project description:Aims/introductionType 2 diabetes mellitus is a progressive disease that frequently requires patients to use more than one oral antihyperglycemic agent to achieve adequate glycemic control. The present multicenter, randomized study assessed the efficacy and safety of the addition of sitagliptin to ongoing voglibose monotherapy (0.2-0.3 mg three times daily) in Japanese patients with type 2 diabetes mellitus who had inadequate glycemic control (glycated hemoglobin ?6.9% and <10.5%).Materials and methodsThe present study had an initial 12-week, double-blind treatment period in which patients were randomized (1:1) to sitagliptin 50 mg/day (n = 70) or placebo (n = 63), followed by a 40-week, open-label treatment period during which all patients received sitagliptin 50 mg/day, that could have been increased to 100 mg/day for patients meeting predefined glycemic criteria.ResultsAfter 12 weeks, treatment with sitagliptin resulted in placebo-subtracted mean changes from baseline in glycated hemoglobin (the primary end-point), fasting plasma glucose and 2-h postmeal glucose of -0.9%, -22.5 mg/dL and -51.3 mg/dL, respectively (all, P < 0.001). During the double-blind period, adverse experiences were reported with similar frequency in both treatment groups, and the occurrences of hypoglycemia and gastrointestinal adverse experiences were low. In the open-label period, sustained improvements in glycemic parameters were observed with sitagliptin treatment, and sitagliptin was generally well tolerated.ConclusionsSitagliptin added on to ongoing voglibose monotherapy provided significant improvements in glycemic parameters and was well tolerated in Japanese patients with type 2 diabetes mellitus who had inadequate glycemic control. This trial was registered with ClinicalTrials.gov (no. NCT00837577).
| S-EPMC4020255 | biostudies-literature
Project description:Hispanics in the United States represent diverse racial, ethnic, and socioeconomic groups, and manifest heterogeneous cardiovascular risks including diabetes. It is not known if there are residual differences in the control of diabetes among Hispanic groups given uniform access to diabetes care.To evaluate glucose control differences among Mexicans, Puerto Ricans, and Dominicans receiving substantial diabetes care and support in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.Secondary analysis of data from a randomized trial comparing two treatment strategies: intensive, targeting glycated hemoglobin below 6.0 %, and standard, targeting glycated hemoglobin between 7.0 % and 7.9 %.Seven hundred and sixteen Hispanic and 6066 non-Hispanic white participants were recruited from 77 clinical sites across the United States and Canada. There were 243 Mexicans, 199 Puerto Ricans, and 150 Dominicans; and 135 of these Hispanic groups were born in the United States.Glycated hemoglobinCompared to Puerto Ricans, Mexicans were more likely (HR=1.38, CI:0.90-2.10) and Dominicans as likely (HR=1.01, CI:0.66-1.54) to achieve glycated hemoglobin goal in the intensive arm. Participants born in the United States achieved glycated hemoglobin goal at a higher rate than those born elsewhere (HR=1.57, CI:0.99-2.51 in the intensive arm, HR=1.51, CI:0.95-2.43 in the standard arm). These differences were not statistically significant. In the intensive arm, Puerto Ricans (OR=0.47, CI:0.31-0.71), and Dominicans (OR=0.41, CI:0.26-0.66) were less likely than non-Hispanic whites to achieve glycated hemoglobin goal, whereas the difference between non-Hispanic whites and Mexicans was not statistically significant, (OR=0.66, CI:0.43-1.02).Hispanic groups, given access to comprehensive diabetes care, differed from each other non-significantly and had a variable divergence from non-Hispanic whites in achieving intensive glycated hemoglobin goal. These differences, if confirmed, could be due to such factors as variable acculturation and functional health literacy levels that were not measured in the ACCORD trial, but should be further explored in future studies.
| S-EPMC3475813 | biostudies-other
Project description:IntroductionLinagliptin is a xanthine-based dipeptidyl peptidase (DPP)-4 inhibitor that is now available in numerous countries worldwide for the treatment of type 2 diabetes mellitus (T2DM). The aim of this study was to evaluate further the mechanisms underlying the improvements in glycemic control observed with linagliptin. The effects of linagliptin on DPP-4, pharmacodynamic parameters, and glycemic control versus placebo were assessed in patients with inadequately controlled T2DM.MethodsPatients in this phase 2a, multicenter, randomized, double-blind, placebo-controlled study received placebo (n = 40) or linagliptin 5 mg (n = 40). Sitagliptin 100 mg (n = 41) once daily for 4 weeks was included for exploratory purposes. Primary endpoints for linagliptin versus placebo: change from baseline to day 28 in 24-h weighted mean glucose (WMG) and intact glucagon-like peptide (GLP)-1 area under the time-effect curve between 0 and 2 h (AUEC(0-2h)) following meal tolerance test on day 28.ResultsLinagliptin increased intact GLP-1 AUEC(0-2h) (+18.1 pmol/h/L) and lowered 24-h WMG (-1.1 mmol/L) versus placebo (both P < 0.0001) after 28 days. Intact glucose-dependent insulinotropic polypeptide increased in line with GLP-1 (+91.4 pmol/h/L increase vs. placebo; P < 0.0001). Glycated hemoglobin (-0.22%; P = 0.0021), fasting plasma glucose (-0.6 mmol/L; P = 0.0283), and glucose (AUEC(0-3h)) (-5.9 mmol/h/L; P < 0.0001) improved significantly with linagliptin versus placebo. Most adverse events were mild; hypoglycemia or serious adverse events were not reported. Sustained DPP-4 inhibition (≥80%) throughout the treatment period was accompanied by significant reductions in glucagon starting at day 1 of linagliptin administration.ConclusionLinagliptin was well tolerated and effectively inhibited plasma DPP-4 activity in patients with T2DM, producing immediate improvements in incretin levels, glucagon suppression, and glycemic control that were maintained throughout the study period.
| S-EPMC3508116 | biostudies-literature