Eun Ky Kim1,2, Soo Heon Kwak2, Hye Seung Jung2, Bo Kyung Koo2,3, Min Kyong Moon2,3, Soo Lim2,4, Hak Chul Jang2,4, Kyong Soo Park2, Young Min Cho5. 1. International Healthcare Center, Seoul National University Hospital, Seoul, Korea. 2. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea. 3. Department of Internal Medicine, Boramae Medical Center, Seoul, Korea. 4. Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. 5. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea ymchomd@snu.ac.kr.
Abstract
OBJECTIVE: This study evaluated the efficacy of a smartphone-based, patient-centered diabetes care system (mDiabetes) for type 2 diabetes that contains comprehensive modules for glucose monitoring, diet, physical activity, and a clinical decision support system. RESEARCH DESIGN AND METHODS: We conducted a 24-week, multicenter, randomized controlled trial with adult patients with inadequately controlled type 2 diabetes. The patients were randomly assigned to the mDiabetes group or the paper logbook (pLogbook) group. The primary end point was the difference of the change in HbA1c from baseline between the two groups. RESULTS:HbA1c reduction from baseline was greater in the mDiabetes group (-0.40 ± 0.09%, n = 90) than in the pLogbook group (-0.06 ± 0.10%, n = 82). The difference of adjusted mean changes was 0.35% (95% CI 0.14-0.55, P = 0.001). The proportion of patients whose HbA1c fell below 7.0% (53 mmol/mol) was 41.1% for the mDiabetes group and 20.7% for the pLogbook group (odds ratio [OR] 2.01, 95% CI 1.24-3.25, P = 0.003). The percentage of patients who attained HbA1c levels below 7.0% (53 mmol/mol) without hypoglycemia was 31.1% in the mDiabetes group and 17.1% in the pLogbook group (OR 1.82, 95% CI 1.03-3.21, P = 0.024). There was no difference in the event numbers of severe hyperglycemia and hypoglycemia between the two groups. CONCLUSIONS: The implementation of the mDiabetes for patients with inadequately controlled type 2 diabetes resulted in a significant reduction in HbA1c levels, with tolerable safety profiles.
RCT Entities:
OBJECTIVE: This study evaluated the efficacy of a smartphone-based, patient-centered diabetes care system (mDiabetes) for type 2 diabetes that contains comprehensive modules for glucose monitoring, diet, physical activity, and a clinical decision support system. RESEARCH DESIGN AND METHODS: We conducted a 24-week, multicenter, randomized controlled trial with adult patients with inadequately controlled type 2 diabetes. The patients were randomly assigned to the mDiabetes group or the paper logbook (pLogbook) group. The primary end point was the difference of the change in HbA1c from baseline between the two groups. RESULTS: HbA1c reduction from baseline was greater in the mDiabetes group (-0.40 ± 0.09%, n = 90) than in the pLogbook group (-0.06 ± 0.10%, n = 82). The difference of adjusted mean changes was 0.35% (95% CI 0.14-0.55, P = 0.001). The proportion of patients whose HbA1c fell below 7.0% (53 mmol/mol) was 41.1% for the mDiabetes group and 20.7% for the pLogbook group (odds ratio [OR] 2.01, 95% CI 1.24-3.25, P = 0.003). The percentage of patients who attained HbA1c levels below 7.0% (53 mmol/mol) without hypoglycemia was 31.1% in the mDiabetes group and 17.1% in the pLogbook group (OR 1.82, 95% CI 1.03-3.21, P = 0.024). There was no difference in the event numbers of severe hyperglycemia and hypoglycemia between the two groups. CONCLUSIONS: The implementation of the mDiabetes for patients with inadequately controlled type 2 diabetes resulted in a significant reduction in HbA1c levels, with tolerable safety profiles.
Authors: Lyndsay A Nelson; Robert A Greevy; Andrew Spieker; Kenneth A Wallston; Tom A Elasy; Sunil Kripalani; Chad Gentry; Erin M Bergner; Lauren M LeStourgeon; Sarah E Williamson; Lindsay S Mayberry Journal: Diabetes Care Date: 2020-11-05 Impact factor: 19.112
Authors: María Begoña Martos-Cabrera; Almudena Velando-Soriano; Laura Pradas-Hernández; Nora Suleiman-Martos; Guillermo A Cañadas-De la Fuente; Luis Albendín-García; José L Gómez-Urquiza Journal: J Clin Med Date: 2020-03-04 Impact factor: 4.241