Evaluation of a digital diabetes prevention program adapted for the Medicaid population: Study design and methods for a non-randomized, controlled trial

Kim, Sue E.; Sweet, Cynthia Castro; Gibson, Eliza; Madero, Erica N.; Rubino, Barbara; Morrison, Janina L.; Rosen, Debra; Imberg, Wendy; Cousineau, Michael R.

doi:10.1016/j.conctc.2018.05.007

Cited by 18 publications

(61 citation statements)

References 32 publications

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“…Self-administered AccuBase A 1c Mail-In Test Kits (DTI Laboratories, Inc., Thomasville, GA, USA) were used to assess baseline and 3-month hemoglobin A 1c levels. This test is FDA-approved, certified by the National Glycohemoglobin Standardization Program, Clinical Laboratory Improvement Amendments-waived, and a highly accurate assessment of hemoglobin A 1c used in randomized and nonrandomized trials [ 22 , 23 ]. It is a nonfasting, finger stick, whole blood mail-in test.…”

Section: Methodsmentioning

confidence: 99%

One Drop App With an Activity Tracker for Adults With Type 1 Diabetes: Randomized Controlled Trial

Osborn¹,

Hirsch²,

Sears³

et al. 2020

JMIR Mhealth Uhealth

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Background In 2017, mobile app support for managing diabetes was available to 64% of the global population of adults with diabetes. One Drop’s digital therapeutics solution includes an evidence-based mobile app with global reach, a Bluetooth-connected glucometer, and in-app coaching from Certified Diabetes Educators. Among people with type 1 diabetes and an estimated hemoglobin A1c level≥7.5%, using One Drop for 3 months has been associated with an improved estimated hemoglobin A1c level of 22.2 mg/dL (–0.80%). However, the added value of integrated activity trackers is unknown. Objective We conducted a pragmatic, remotely administered randomized controlled trial to evaluate One Drop with a new-to-market activity tracker against One Drop only on the 3-month hemoglobin A1c level of adults with type 1 diabetes. Methods Social media advertisements and online newsletters were used to recruit adults (≥18 years old) diagnosed (≥1 year) with T1D, naïve to One Drop’s full solution and the activity tracker, with a laboratory hemoglobin A1c level≥7%. Participants (N=99) were randomized to receive One Drop and the activity tracker or One Drop only at the start of the study. The One Drop only group received the activity tracker at the end of the study. Multiple imputation, performed separately by group, was used to correct for missing data. Analysis of covariance models, controlling for baseline hemoglobin A1c, were used to evaluate 3-month hemoglobin A1c differences in intent-to-treat (ITT) and per protocol (PP) analyses. Results The enrolled sample (N=95) had a mean age of 41 (SD 11) years, was 73% female, 88% White, diagnosed for a mean of 20 (SD 11) years, and had a mean hemoglobin A1c level of 8.4% (SD 1.2%); 11% of the participants did not complete follow up. Analysis of covariance assumptions were met for the ITT and PP models. In ITT analysis, participants in the One Drop and activity tracker condition had a significantly lower 3-month hemoglobin A1c level (mean 7.9%, SD 0.60%, 95% CI 7.8-8.2) than that of the participants in the One Drop only condition (mean 8.4%, SD 0.62%, 95% CI 8.2-8.5). In PP analysis, participants in the One Drop and activity tracker condition also had a significantly lower 3-month hemoglobin A1c level (mean 7.9%, SD 0.59%, 95% CI 7.7-8.1) than that of participants in the One Drop only condition (mean 8.2%, SD 0.58%, 95% CI 8.0-8.4). Conclusions Participants exposed to One Drop and the activity tracker for the 3-month study period had a significantly lower 3-month hemoglobin A1c level compared to that of participants exposed to One Drop only during the same timeframe. One Drop and a tracker may work better together than alone in helping people with type 1 diabetes. Trial Registration ClinicalTrials.gov NCT03459573; https://clinicaltrials.gov/ct2/show/NCT03459573.

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Section: Methodsmentioning

confidence: 99%

One Drop App With an Activity Tracker for Adults With Type 1 Diabetes: Randomized Controlled Trial

Osborn¹,

Hirsch²,

Sears³

et al. 2020

JMIR Mhealth Uhealth

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“…The target population was adults (aged 18–75 years) enrolled in Medicaid or another safety-net insurance plan, and with evidence of prediabetes in their electronic health record (EHR). Our previous publication describes implementation of the digital DPP for a low-income population, including study design, protocol, and inclusion and exclusion criteria (20). We registered this study at ClinicalTrials.gov (NCT02664064), and our analyses are based on the previous protocol.…”

Section: Methodsmentioning

confidence: 99%

“…The intervention is a digital DPP that includes virtual group support, personalized health coaching, weekly lessons, and digital progress tracking tools (20,22). The program begins with an intensive 16-week phase, followed by a 36-week maintenance phase.…”

Section: Methodsmentioning

confidence: 99%

Evaluation of a Digital Diabetes Prevention Program Adapted for Low-Income Patients, 2016–2018

Kim

Sweet²,

Cho

et al. 2019

Prev. Chronic Dis.

Self Cite

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IntroductionWe examined the effects of a digitally delivered, type 2 diabetes mellitus prevention program (DPP) for a low-income population.MethodsWe 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.ResultsA 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.ConclusionThe 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.

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“…Another communication strategy was an approach using any kind of technical device. Overall, nine studies focused on TA in combination with an ADPP [16,33,[36][37][38][39][40][41][42], but two used a TA alone [36,37].…”

Section: Technological Approachesmentioning

confidence: 99%

Communication strategies in the prevention of type 2 diabetes and gestational diabetes in vulnerable groups: A scoping review

Breuing

Gräf

Neuhaus

et al. 2020

Preprint

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Background The global prevalence of diabetes is nearly 9%, with an upward trend in type 2 diabetes mellitus (T2DM) and gestational diabetes (GDM). Although evidence shows that vulnerable groups are affected disproportionally, these groups are difficult to reach in terms of preventive measures. Currently, there is no gold standard regarding communication strategies and/or public awareness campaigns. Methods We conducted a scoping review in September 2019. Two reviewers independently screened the results of the electronic literature search in several databases, including Medline, EMBASE, and PsycINFO. Extracted data were charted, categorized, and summarized. Results All of the included articles (n = 24) targeted T2DM; none targeted GDM. We identified the following five different vulnerable groups within the identified studies: migrants (n = 9), ethnic groups such as African Americans (n = 8), people with low socioeconomic status (n = 3), older people (n = 1) and people in need of care (n = 1). Three categories of communication strategies were identified as follows: adapted diabetes prevention programs (n = 21), community health workers (n = 5), and technical approaches (n = 9). Conclusion We found different approaches for preventive interventions for T2DM. Some of these approaches were already adapted to known barriers. Communication strategies should be adapted to barriers and facilitating factors to increase participation and motivation.

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Evaluation of a digital diabetes prevention program adapted for the Medicaid population: Study design and methods for a non-randomized, controlled trial

Cited by 18 publications

References 32 publications

One Drop App With an Activity Tracker for Adults With Type 1 Diabetes: Randomized Controlled Trial

One Drop App With an Activity Tracker for Adults With Type 1 Diabetes: Randomized Controlled Trial

Evaluation of a Digital Diabetes Prevention Program Adapted for Low-Income Patients, 2016–2018

Communication strategies in the prevention of type 2 diabetes and gestational diabetes in vulnerable groups: A scoping review

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