Medication Optimization Among People With Type 2 Diabetes Participating in a CGM-Driven Virtual Care Program: Prospective Trial (Preprint)

2021 ◽  
Author(s):  
Amit R Majithia ◽  
David M Erani ◽  
Coco M Kusiak ◽  
Jennifer E Layne ◽  
Amy Armento Lee ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Diabetes Management ◽  
Medication Management ◽  
Prospective Trial ◽  
Care Program ◽  
Mobile App ◽  
Medication Change ◽  
Virtual Care ◽  
Medication Optimization

BACKGROUND The Onduo virtual care program for people with type 2 diabetes (T2D) includes a mobile app, remote lifestyle coaching, connected devices and telemedicine consultations with endocrinologists for medication management and prescription of real-time continuous glucose monitoring (RT-CGM) devices. In a previously described 4-month prospective study of this program, adults with T2D and baseline HbA1c ≥8.0% to ≤12.0% experienced a mean HbA1c decrease of 1.6% with no significant increase in hypoglycemia. OBJECTIVE The objective of this analysis was to evaluate medication optimization and management in the 4-month prospective T2D study. METHODS Study participants received at least 1 telemedicine consultation with an Onduo endocrinologist for diabetes medication management and used RT-CGM intermittently to guide therapy and dosing. Medication changes were analyzed. RESULTS A total of 48 (87%) out of 55 participants had a medication change consisting of a dose change, addition, or discontinuation. Of these, 15 (31%) of participants had a net increase in number of diabetes medications classes from baseline. Mean time to first medication change for these participants was 36 days. The percentage of participants taking a GLP-1 receptor agonist increased from 25% to 56%, while the percentages of participants taking a sulfonylurea or DPP-4 inhibitor decreased from 56% to 33% and 17% to 6%, respectively. Prescriptions of other anti-diabetic medication classes including insulin did not change significantly. CONCLUSIONS The Onduo virtual care program can play an important role in providing timely access to guideline-based diabetes management medications and technologies for people with T2D. CLINICALTRIAL ClinicalTrials.gov NCT0386538

scholarly journals A Virtual Type 2 Diabetes Clinic Using Continuous Glucose Monitoring and Endocrinology Visits

2019 ◽  
Vol 14 (5) ◽  
pp. 908-911 ◽  
Author(s):  
Ronald F. Dixon ◽  
Howard Zisser ◽  
Jennifer E. Layne ◽  
Nathan A. Barleen ◽  
David P. Miller ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Diabetes Management ◽  
Medication Management ◽  
Glucose Monitoring ◽  
Mobile App ◽  
Office Visits ◽  
Continuous Glucose Monitor ◽  
Diabetes Clinic ◽  
Clinical Support

The Onduo Virtual Diabetes Clinic (VDC) telehealth technology/care model for adults with type 2 diabetes (T2D) combines connected devices, remote lifestyle coaching, and clinical support with a mobile App. Key differentiating program features are the availability of live video consultations with board-certified endocrinologists for medication management and real-time continuous glucose monitor use for higher-risk participants. Preliminary data ( n = 740) suggest that participation was associated with a significant improvement in HbA1c with up to 6 months follow-up in those not meeting treatment targets. HbA1c decreased by 2.3% ± 1.9%, 0.7% ± 1.0%, and 0.2% ± 0.8% across baseline categories of >9.0%, 8.0%-9.0% and 7.0% to <8.0%, respectively (all P < .001). These findings suggest that the VDC has potential to support individuals with T2D and their clinicians in diabetes management between office visits.

scholarly journals Glycemic Outcomes in Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor–Driven Virtual Diabetes Clinic: Prospective Trial

10.2196/21778 ◽  
2020 ◽  
Vol 22 (8) ◽  
pp. e21778 ◽  
Author(s):  
Amit R Majithia ◽  
Coco M Kusiak ◽  
Amy Armento Lee ◽  
Francis R Colangelo ◽  
Robert J Romanelli ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Continuous Glucose Monitoring ◽  
Prospective Trial ◽  
Glucose Monitoring ◽  
Mobile App ◽  
Diabetes Clinic ◽  
Percent Time ◽  
Glycemic Outcomes

Background The Onduo virtual diabetes clinic (VDC) for people with type 2 diabetes (T2D) combines a mobile app, remote personalized lifestyle coaching, connected devices, and live video consultations with board-certified endocrinologists for medication management and prescription of real-time continuous glucose monitoring (RT-CGM) devices for intermittent use. Objective This prospective single-arm study evaluated glycemic outcomes associated with participation in the Onduo VDC for 4 months. Methods Adults aged ≥18 years with T2D and a baseline glycated hemoglobin (HbA1c) of ≥8% to ≤12% were enrolled from 2 primary care centers from February 2019 to October 2019. Participants were asked to engage at ≥1 time per week with their care team and to participate in a telemedicine consultation with a clinic endocrinologist for diabetes medication review. Participants were asked to use a RT-CGM device and wear six 10-day sensors (total 60 days of sensor wear) intermittently over the course of 4 months. The primary outcome was change in HbA1c at 4 months from baseline. Other endpoints included change in weight and in RT-CGM glycemic metrics, including percent time <70, 70-180, 181-250, and >250 mg/dL. Changes in blood pressure and serum lipids at 4 months were also evaluated. Results Participants (n=55) were 57.3 (SD 11.6) years of age, body mass index 33.7 (SD 7.2), and 40% (22/55) female. HbA1c decreased significantly by 1.6% (SD 1%; P<.001). When stratified by baseline HbA1c of 8.0% to 9.0% (n=36) and >9.0% (n=19), HbA1c decreased by 1.2% (SD 0.6%; P<.001) and 2.4% (SD 1.3%; P<.001), respectively. Continuous glucose monitoring–measured (n=43) percent time in range (TIR) 70-180 mg/dL increased by 10.2% (SD 20.5%; P=.002), from 65.4% (SD 23.2%) to 75.5% (SD 22.7%), which was equivalent to a mean increase of 2.4 hours TIR per day. Percent time 181-250 mg/dL and >250 mg/dL decreased by 7.2% (SD 15.4; P=.005) and 3.0% (SD 9.4; P=.01), respectively. There was no change in percent time <70 mg/dL. Mean weight decreased by 9.0 lb (SD 10.4; P<.001). Significant improvements were also observed in systolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and triglycerides (P=.04 to P=<.001). Conclusions Participants in the Onduo VDC experienced significant improvement in HbA1c, increased TIR, decreased time in hyperglycemia, and no increase in hypoglycemia at 4 months. Improvements in other metabolic health parameters including weight and blood pressure were also observed. In conclusion, the Onduo VDC has potential to support people with T2D and their clinicians between office visits by increasing access to specialty care and advanced diabetes technology including RT-CGM. Trial Registration ClinicalTrials.gov NCT03865381; https://clinicaltrials.gov/ct2/show/NCT03865381

scholarly journals Identification of Type 2 Diabetes Management Mobile App Features and Engagement Strategies: Modified Delphi Approach (Preprint)

2019 ◽  
Author(s):  
Hanan A Alenazi ◽  
Amr Jamal ◽  
Mohammed A Batais
Keyword(s):  
Type 2 Diabetes ◽  
Blood Glucose ◽  
Diabetes Management ◽  
Mobile App ◽  
Patient Specific ◽  
Moderate Degree ◽  
Modified Delphi ◽  
Engagement Strategies ◽  
Delphi Approach

BACKGROUND Diabetes is a significant public health issue. Saudi Arabia has the highest prevalence of type 2 diabetes mellitus (T2DM) in the Arab world. Currently, it affects 31.6% of the general population, and the prevalence of T2DM is predicted to rise to 45.36% by 2030. Mobile health (mHealth) offers improved and cost-effective care to people with T2DM. However, the efficiency of engagement strategies and features of this technology need to be reviewed and standardized according to stakeholder and expert perspectives. OBJECTIVE The main objective of this study was to identify the most agreed-upon features for T2DM self-management mobile apps; the secondary objective was to identify the most agreed-upon strategies that prompt users to use these apps. METHODS In this study, a 4-round modified Delphi method was applied by experts in the domain of diabetes care. RESULTS In total, 11 experts with a mean age of 47.09 years (SD 11.70) consented to participate in the study. Overall, 36 app features were generated. The group of experts displayed weak agreement in their ranking of intervention components (Kendall W=0.275; <i>P</i>&lt;.001). The top 5 features included insulin dose adjustment according to carbohydrate counting and blood glucose readings (5.36), alerting a caregiver of abnormal or critical readings (6.09), nutrition education (12.45), contacts for guidance if required (12.64), and offering patient-specific education tailored to the user’s goals, needs, and blood glucose readings (12.90). In total, 21 engagement strategies were generated. Overall, the experts showed a moderate degree of consensus in their strategy rankings (Kendall W=0.454; <i>P</i>&lt;.001). The top 5 engagement strategies included a user-friendly design (educational and age-appropriate design; 2.82), a free app (3.73), allowing the user to communicate or send information/data to a health care provider (HCP; 5.36), HCPs prescribing the mobile app in the clinic and asking about patients’ app use compliance during clinical visits (6.91), and flexibility and customization (7.91). CONCLUSIONS This is the first study in the region consisting of a local panel of experts from the diabetes field gathering together. We used an iterative process to combine the experts’ opinions into a group consensus. The results of this study could thus be useful for health app developers and HCPs and inform future decision making on the topic.

scholarly journals Identification of Type 2 Diabetes Management Mobile App Features and Engagement Strategies: Modified Delphi Approach

10.2196/17083 ◽  
2020 ◽  
Vol 8 (9) ◽  
pp. e17083
Author(s):  
Hanan A Alenazi ◽  
Amr Jamal ◽  
Mohammed A Batais
Keyword(s):  
Type 2 Diabetes ◽  
Blood Glucose ◽  
Diabetes Management ◽  
Mobile App ◽  
Patient Specific ◽  
Moderate Degree ◽  
Modified Delphi ◽  
Engagement Strategies ◽  
Delphi Approach

Background Diabetes is a significant public health issue. Saudi Arabia has the highest prevalence of type 2 diabetes mellitus (T2DM) in the Arab world. Currently, it affects 31.6% of the general population, and the prevalence of T2DM is predicted to rise to 45.36% by 2030. Mobile health (mHealth) offers improved and cost-effective care to people with T2DM. However, the efficiency of engagement strategies and features of this technology need to be reviewed and standardized according to stakeholder and expert perspectives. Objective The main objective of this study was to identify the most agreed-upon features for T2DM self-management mobile apps; the secondary objective was to identify the most agreed-upon strategies that prompt users to use these apps. Methods In this study, a 4-round modified Delphi method was applied by experts in the domain of diabetes care. Results In total, 11 experts with a mean age of 47.09 years (SD 11.70) consented to participate in the study. Overall, 36 app features were generated. The group of experts displayed weak agreement in their ranking of intervention components (Kendall W=0.275; P<.001). The top 5 features included insulin dose adjustment according to carbohydrate counting and blood glucose readings (5.36), alerting a caregiver of abnormal or critical readings (6.09), nutrition education (12.45), contacts for guidance if required (12.64), and offering patient-specific education tailored to the user’s goals, needs, and blood glucose readings (12.90). In total, 21 engagement strategies were generated. Overall, the experts showed a moderate degree of consensus in their strategy rankings (Kendall W=0.454; P<.001). The top 5 engagement strategies included a user-friendly design (educational and age-appropriate design; 2.82), a free app (3.73), allowing the user to communicate or send information/data to a health care provider (HCP; 5.36), HCPs prescribing the mobile app in the clinic and asking about patients’ app use compliance during clinical visits (6.91), and flexibility and customization (7.91). Conclusions This is the first study in the region consisting of a local panel of experts from the diabetes field gathering together. We used an iterative process to combine the experts’ opinions into a group consensus. The results of this study could thus be useful for health app developers and HCPs and inform future decision making on the topic.

scholarly journals A Personalized Mobile Health Program for Type 2 Diabetes During the COVID-19 Pandemic: Single-Group Pre–Post Study (Preprint)

2020 ◽  
Author(s):  
Ian Yi Han Ang ◽  
Kyle Xin Quan Tan ◽  
Clive Tan ◽  
Chiew Hoon Tan ◽  
James Wei Ming Kwek ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Chronic Disease ◽  
Disease Management ◽  
Mobile Health ◽  
Intervention Program ◽  
Chronic Disease Management ◽  
Diabetes Management ◽  
Mobile App ◽  
Diabetes Status

BACKGROUND With increasing type 2 diabetes prevalence, there is a need for effective programs that support diabetes management and improve type 2 diabetes outcomes. Mobile health (mHealth) interventions have shown promising results. With advances in wearable sensors and improved integration, mHealth programs could become more accessible and personalized. OBJECTIVE The study aimed to evaluate the feasibility, acceptability, and effectiveness of a personalized mHealth-anchored intervention program in improving glycemic control and enhancing care experience in diabetes management. The program was coincidentally implemented during the national-level lockdown for COVID-19 in Singapore, allowing for a timely study of the use of mHealth for chronic disease management. METHODS Patients with type 2 diabetes or prediabetes were enrolled from the Singapore Armed Forces and offered a 3-month intervention program in addition to the usual care they received. The program was standardized to include (1) in-person initial consultation with a clinical dietitian; (2) in-person review with a diabetes specialist doctor; (3) 1 continuous glucose monitoring device; (4) access to the mobile app for dietary intake and physical activity tracking, and communication via messaging with the dietitian and doctor; and (5) context-sensitive digital health coaching over the mobile app. Medical support was rendered to the patients on an as-needed basis when they required advice on adjustment of medications. Measurements of weight, height, and glycated hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>) were conducted at 2 in-person visits at the start and end of the program. At the end of the program, patients were asked to complete a short acceptability feedback survey to understand the motivation for joining the program, their satisfaction, and suggestions for improvement. RESULTS Over a 4-week recruitment period, 130 individuals were screened, the enrollment target of 30 patients was met, and 21 patients completed the program and were included in the final analyses; 9 patients were lost to follow-up (full data were not available for the final analyses). There were no differences in the baseline characteristics between patients who were included and excluded from the final analyses (age category: <i>P</i>=.23; gender: <i>P</i>=.21; ethnicity: <i>P</i>&gt;.99; diabetes status category: <i>P</i>=.52, medication adjustment category: <i>P</i>=.65; HbA<sub>1c</sub> category: <i>P</i>=.69; BMI: <i>P</i>&gt;.99). The 21 patients who completed the study rated a mean of 9.0 out of 10 on the Likert scale for both satisfaction questions. For the Yes-No question on benefit of the program, all of the patients selected “Yes.” Mean HbA<sub>1c</sub> decreased from 7.6% to 7.0% (<i>P</i>=.004). There were no severe hypoglycemia events (glucose level &lt;3.0 mmol/L) reported. Mean weight decreased from 76.8 kg to 73.9 kg (<i>P</i>&lt;.001), a mean decrease of 3.5% from baseline weight. Mean BMI decreased from 27.8 kg/m<sup>2</sup> to 26.7 kg/m<sup>2</sup> (<i>P</i>&lt;.001). CONCLUSIONS The personalized mHealth program was feasible, acceptable, and produced significant reductions in HbA<sub>1c</sub> (<i>P</i>=.004) and body weight (<i>P</i>&lt;.001) in individuals with type 2 diabetes. Such mHealth programs could overcome challenges posed to chronic disease management by COVID-19, including disruptions to in-person health care access. CLINICALTRIAL

scholarly journals Rethinking Models of Outpatient Specialist Care in Type 2 Diabetes Using eHealth: Study Protocol for a Pilot Randomised Controlled Trial

2019 ◽  
Vol 16 (6) ◽  
pp. 959 ◽  
Author(s):  
Anish Menon ◽  
Farhad Fatehi ◽  
Dominique Bird ◽  
Darsy Darssan ◽  
Mohan Karunanithi ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Glycaemic Control ◽  
Diabetes Management ◽  
Mobile App ◽  
Research Centre ◽  
Randomised Control Trial ◽  
Outpatient Services ◽  
Model Of Care ◽  
New Model

Conventional outpatient services are unlikely to meet burgeoning demand for diabetes services given increasing prevalence of diabetes, and resultant impact on the healthcare workforce and healthcare costs. Disruptive technologies (such as smartphone and wireless sensors) create an opportunity to redesign outpatient services. In collaboration, the Department of Diabetes and Endocrinology at Brisbane Princess Alexandra Hospital, the University of Queensland Centre for Health Services Research and the Australian e-Health Research Centre developed a mobile diabetes management system (MDMS) to support the management of complex outpatient type 2 diabetes mellitus (T2DM) adults. The system comprises of a mobile App, an automated text-messaging feedback and a clinician portal. Blood glucose levels (BGL) data are automatically transferred by Bluetooth-enabled glucose meter to the clinician portal via the mobile App. The primary aim of the study described here is to examine improvement in glycaemic control of a new model of care employing MDMS for patients with complex T2DM attending a tertiary level outpatient service. A two-group, 12-month, pilot pragmatic randomised control trial will recruit 44 T2DM patients. The control group will receive routine care. The intervention group will be supported by the MDMS enabling the participants to potentially better self-manage their diabetes, and the endocrinologists to remotely monitor BGL and to interact with patients through a variety of eHealth modalities. Intervention participants will be encouraged to complete relevant pathology tests, and report on current diabetes management through an online questionnaire. Using this information, the endocrinologist may choose to reschedule the appointment or substitute it with a telephone or video-consultation. This pilot study will guide the conduct of a large-scale study regarding the capacity for a new model of care. This model utilises multimodal eHealth strategies via the MDMS to primarily improve glycaemic control with secondary aims to improve patient experience, reduce reliance on physical clinics, and decrease service delivery cost.

scholarly journals My Diabetes Coach, a Mobile App–Based Interactive Conversational Agent to Support Type 2 Diabetes Self-Management: Randomized Effectiveness-Implementation Trial (Preprint)

2020 ◽  
Author(s):  
Enying Gong ◽  
Shaira Baptista ◽  
Anthony Russell ◽  
Paul Scuffham ◽  
Michaela Riddell ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Controlled Trial ◽  
Care Program ◽  
Mobile App ◽  
Self Management ◽  
Management Support ◽  
Conversational Agent ◽  
Home Setting ◽  
And Control

BACKGROUND Delivering self-management support to people with type 2 diabetes mellitus is essential to reduce the health system burden and to empower people with the skills, knowledge, and confidence needed to take an active role in managing their own health. OBJECTIVE This study aims to evaluate the adoption, use, and effectiveness of the My Diabetes Coach (MDC) program, an app-based interactive embodied conversational agent, <i>Laura</i>, designed to support diabetes self-management in the home setting over 12 months. METHODS This randomized controlled trial evaluated both the implementation and effectiveness of the MDC program. Adults with type 2 diabetes in Australia were recruited and randomized to the intervention arm (MDC) or the control arm (usual care). Program use was tracked over 12 months. Coprimary outcomes included changes in glycated hemoglobin (HbA<sub>1c</sub>) and health-related quality of life (HRQoL). Data were assessed at baseline and at 6 and 12 months, and analyzed using linear mixed-effects regression models. RESULTS A total of 187 adults with type 2 diabetes (mean 57 years, SD 10 years; 41.7% women) were recruited and randomly allocated to the intervention (n=93) and control (n=94) arms. MDC program users (92/93 participants) completed 1942 chats with <i>Laura</i>, averaging 243 min (SD 212) per person over 12 months. Compared with baseline, the mean estimated HbA<sub>1c</sub> decreased in both arms at 12 months (intervention: 0.33% and control: 0.20%), but the net differences between the two arms in change of HbA<sub>1c</sub> (−0.04%, 95% CI −0.45 to 0.36; <i>P</i>=.83) was not statistically significant. At 12 months, HRQoL utility scores improved in the intervention arm, compared with the control arm (between-arm difference: 0.04, 95% CI 0.00 to 0.07; <i>P</i>=.04). CONCLUSIONS The MDC program was successfully adopted and used by individuals with type 2 diabetes and significantly improved the users’ HRQoL. These findings suggest the potential for wider implementation of technology-enabled conversation-based programs for supporting diabetes self-management. Future studies should focus on strategies to maintain program usage and HbA<sub>1c</sub> improvement. CLINICALTRIAL Australia New Zealand Clinical Trials Registry (ACTRN) 12614001229662; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614001229662

Mobile App Use in Adults with Comorbid Type 2 Diabetes and Depression

2021 ◽  
pp. 019394592098879
Author(s):  
Diane Orr Chlebowy ◽  
Mary-Beth Coty ◽  
Adrian Lauf ◽  
Sathya Krishnasamy ◽  
John Myers ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Diabetes Management ◽  
Mobile Apps ◽  
Mobile App ◽  
Advanced Degree ◽  
Graduate Degree ◽  
Convenience Sample ◽  
Intent To Use ◽  
Mhealth Apps

The purpose of this preliminary study was to determine smartphone usage, expressed level of interest, and intent to use mHealth apps among adults with comorbid type 2 diabetes (T2D) and depression. A convenience sample of adults (N=35) completed a Demographic and Mobile App Survey and the CESD-R-10. A majority reported using mobile apps (n=23, 65.7%) and felt comfortable or very comfortable using mobile apps (n=14, 46.7%). However, few respondents used a health app (n=6, 17.1%) or a diabetes-specific app for diabetes management (n=3, 8.6%). Adjusted, age and education were the two variables that independently impacted app use; those aged less than 55 years as well as those with a graduate degree were more likely to use apps. Being younger and having an advanced degree increased the odds of using a diabetes-specific app. The findings suggest that adults with T2D are amenable to using mHealth apps to manage diabetes.

Self-Efficacy Effects of Maccabi Telcare Center Diabetes Mellitus Intervention: Do Men and Women Benefit Equally?

2021 ◽  
pp. RTNP-D-20-00083
Author(s):  
Angela Irony ◽  
Racheli Magnezi ◽  
Yael Vilensky Sela
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Gender Differences ◽  
Type 2 Diabetes Mellitus ◽  
Self Efficacy ◽  
Diabetes Management ◽  
Prospective Trial ◽  
Illness Representation ◽  
Men And Women

Background and PurposeA growing body of evidence points to physiological and psychological gender differences in the manifestation and treatment of type 2 diabetes mellitus. This study is part of a large-scale, prospective trial investigating the effects of Maccabi Telecare Center (MTC) interventions on self-efficacy. Here, we focus on the effects of gender on diabetes self-efficacy related to depressive symptom severity and illness representation.MethodsA prospective open-label study investigating the effect of tele-based intervention on diabetes self-efficacy. Participants completed the following questionnaires: Diabetes Management Self-Efficacy Scale (DMSES) (self-efficacy), Patient Health Questionnaire 9 (PHQ-9) (depression), and Illness Perception Questionnaire-Revised (IPQ-R) (illness representation). Data were collected at three time points: Baseline (T1), 3–4 months (T2), and 8–9 months (T3).ResultsAlthough men and women exhibited similar baseline self-efficacy levels, men scored significantly higher than women over time, at T2 (p < .05) and T3 (p < .05). Consistent gender differences were observed throughout the study in depression and illness representations: women scored higher than men on PHQ-9 (3.94 vs. 5.57, p < .001), and perceived their diabetes consequences as more severe than men (p < .001). A linear regression analyses indicated that MTC intervention, age, baseline self-efficacy, and depression at T3 explained 39.8% of the variance of selfefficacy at the conclusion of the study for both genders, although more strongly for men.Implications for PracticeThis study indicates that the effects of a treatment intervention for individuals with type 2 diabetes mellitus are gender specific. Thus, gender-tailored interventions may be advised to further improve outcomes for women with type 2 diabetes mellitus.

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