ABSTRACT
BACKGROUND: Digital therapeutic platforms facilitate health care through patient-centered strategies based on multidisciplinary teams and shared decision-making. Such platforms can be used for developing a dynamic model of diabetes care delivery, which can help in improving glycemic control by promoting long-term behavior changes in people with diabetes. OBJECTIVE: This study aims to evaluate the real-world effectiveness of the Fitterfly Diabetes CGM digital therapeutics program for improving glycemic control in people with type 2 diabetes mellitus (T2DM) after the completion of 90 days in the program. METHODS: We analyzed deidentified data of 109 participants in the Fitterfly Diabetes CGM program. This program was delivered through the Fitterfly mobile app coupled with continuous glucose monitoring (CGM) technology. This program consists of 3 phases: the first phase is observation, wherein the patient's CGM readings are observed for 7 days (week 1); the second phase is the intervention; and the third phase aims at sustaining the lifestyle modification introduced during the second phase. The primary outcome of our study was the change in the participants' hemoglobin A1c (HbA1c) levels after program completion. We also evaluated the changes in participant weight and BMI after the program, changes in the CGM metrics in the initial 2 weeks of the program, and the effects of participant engagement in the program on improving their clinical outcomes. RESULTS: At the end of the 90 days of the program, the mean HbA1c levels, weight, and BMI of the participants were significantly reduced by 1.2% (SD 1.6%), 2.05 (SD 2.84) kg, and 0.74 (SD 1.02) kg/m2 from baseline values of 8.4% (SD 1.7%), 74.45 (SD 14.96) kg, and 27.44 (SD 4.69) kg/m2 in week 1, respectively (P<.001). The average blood glucose levels and time above range values showed a significant mean reduction by 16.44 (SD 32.05) mg/dL and 8.7% (SD 17.1%) in week 2 from week 1 baseline values of 152.90 (SD 51.63) mg/dL and 36.7% (SD 28.4%), respectively (P<.001 for both). Time in range values significantly improved by 7.1% (SD 16.7%) from a baseline value of 57.5% (SD 25%) in week 1 (P<.001). Of all the participants, 46.9% (50/109) showed HbA1c reduction ≥1% and 38.5% (42/109) showed weight loss ≥4%. The average number of times the mobile app was opened by each participant during the program was 108.80 (SD 127.91) times. CONCLUSIONS: Our study shows that participants in the Fitterfly Diabetes CGM program showed a significant improvement in their glycemic control and reduction in weight and BMI. They also showed a high level of engagement with the program. Weight reduction was significantly associated with higher participant engagement with the program. Thus, this digital therapeutic program can be considered as an effective tool for improving glycemic control in people with T2DM.
ABSTRACT
INTRODUCTION: Hypertension (HTN), being a major risk factor for cardiovascular diseases (CVDs), is an important issue of medical and public health. High blood pressure (BP) is ranked as the third most important risk factor for attributable burden of disease in south Asia (2010). Hypertension (HTN) exerts a substantial public health burden on cardiovascular health status and healthcare systems in India. Uncontrolled hypertension among adults with hypertension is associated with increased mortality. An inadequate data is available in India on uncontrolled hypertension. OBJECTIVES: The present study was planned to evaluate the patient profile, co-morbidities, management in uncontrolled hypertensive patients and also to determine the number of patients with resistant hypertension across India. METHODS: A total of 4725 uncontrolled hypertensive patients who were on anti-hypertensive medications were evaluated in this cross-sectional and observational study. The observed patterns were recorded with respect to the prevalence of uncontrolled hypertension and evaluate the socio-demographic, medical history, anthropometric variables and treatment preferences in Indian patients with uncontrolled hypertension. RESULTS: Majority of the patients with uncontrolled hypertension were males (71.4%) and aged 46-65 years. Most of the study population were pre-obese (males: 35.7%; females: 27.4%). Higher proportion of patients with uncontrolled hypertension were residents of Maharashtra (25.6%) and Gujarat (11.6%). Antihypertensive monotherapy was used by 45.4% and 54.6% patients used combination therapy (≥ 2 categories of anti-hypertensive medications). Angiotensin receptor blockers (ARBs) were the most preferred agent as monotherapy (70.6%) and also the most common component of dual and triple combination anti-hypertensive agent. 19.5% (922/4725) patients had resistant hypertension and 80% of the patients were aged 46-65 years. Higher proportion of patients were males (67.2%; 620/922) and higher proportion of patients were to residents of Andhra Pradesh (21.4% patients) and Maharashtra (19.3% patients). All 922 resistant hypertensive patients were on ≥ 3 anti-hypertensive medications and received ARB + CCB + Diuretics as the most preferred anti-hypertensive combination therapy. Diabetes and dyslipidaemia were the major comorbidities reported in patients with uncontrolled and resistant hypertension. Lipid lowering agents followed by oral hypoglycaemic agents and antiplatelet medications were the common concomitant medications used. Various factor responsible for not achieving the desired blood pressure goals may be the physician's lack of awareness about recent hypertensive treatment guidelines that might contribute to patient's poor adherence due to not explaining adequately the benefit and risks of a medication, not giving consideration to the patient's life style, the cost of medication, and inadequate dose titration. CONCLUSIONS: Uncontrolled hypertension is a major problem in India. It is prudent to focus on multiple risk factors while treating hypertension. A combination therapy with multiple blood pressure lowering drugs are important and concerns should be identified while selecting the appropriate dosage of combinations of anti-hypertensive therapy and adherence to the therapy. The preferred choices for mono, dual combination and triple combination anti-hypertensive regimens are ARBs; ARB + CCB; ARB + CCB + Diuretics, respectively. In this study, most of the patients were on monotherapy; however a rationale combination therapy or dose adjustment is required for the effective management of hypertension. The protective measures to be taken to control hypertension includes reduction of physicians inertia, diet and physical activity, regular patient follow-up with BP measurements and counselling, and the improvement in patient adherence.
