Digital Therapeutic Based Randomized Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy: Rationale, Design, and Baseline Characteristics of the BRIGHT Trial
Background The prevalence of type 2 diabetes continues to rise in the United States and worldwide. Although novel pharmacotherapies have shown benefits, not all patients have access to these medications and of those who do, some are unable to tolerate treatment. Behavior change is long known to be f...
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| Format: | Article |
| Language: | English |
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Wiley
2025-08-01
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| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
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| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.124.038737 |
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| author | Mario Enrico Canonico Judith Hsia Frederick A. Masoudi Hayden B. Bosworth Stacy Greene Bryan C. Batch Natia Hamilton Thiago B. de Araujo Matthew Jackson Marsha Broussard Zonda Gooden Nicole L. Guthrie Bjorn Hansell Laura Matteliano‐Madu Kara Mosesso Mark A. Berman Marc P. Bonaca |
| author_facet | Mario Enrico Canonico Judith Hsia Frederick A. Masoudi Hayden B. Bosworth Stacy Greene Bryan C. Batch Natia Hamilton Thiago B. de Araujo Matthew Jackson Marsha Broussard Zonda Gooden Nicole L. Guthrie Bjorn Hansell Laura Matteliano‐Madu Kara Mosesso Mark A. Berman Marc P. Bonaca |
| author_sort | Mario Enrico Canonico |
| collection | DOAJ |
| description | Background The prevalence of type 2 diabetes continues to rise in the United States and worldwide. Although novel pharmacotherapies have shown benefits, not all patients have access to these medications and of those who do, some are unable to tolerate treatment. Behavior change is long known to be foundational for patients with cardiometabolic disease due to its direct positive impact on health outcomes. Cognitive behavioral therapy delivered by a digital therapeutic has the potential to address access to behavioral therapy for patients with type 2 diabetes. Methods The BRIGHT (Digital Therapeutic Based Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy) Trial (NCT05266625) is a randomized, controlled, multicenter, pragmatic, pivotal trial with open‐label extension evaluating the hypothesis that AspyreRx improves glycemic control and cardiometabolic measures in patients with type 2 diabetes compared with a control application added to usual care across a broad range of patients in a real‐world setting. The current study objectives are to evaluate the efficacy and safety of AspyreRx at 90 and 180 days compared with a control group and to assess the long‐term effectiveness, safety, and impact on health care and medication use over long‐term follow up. Conclusions The AspyreRx digital therapeutic is a Food and Drug Administration approved therapy for patients with type 2 diabetes. Although its efficacy for lowering hemoglobin A1C at 90 days was demonstrated, opportunities remain to better understand the long‐term effects and the effectiveness and safety in a broader and more diverse real‐world environment. BRIGHT is designed to evaluate these questions using a virtual, decentralized, model and include a diverse site mix designed to better understand real‐world effectiveness and generalizability. |
| format | Article |
| id | doaj-art-a058bc8dc0b543c3943fb8236cd4ad3b |
| institution | Kabale University |
| issn | 2047-9980 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj-art-a058bc8dc0b543c3943fb8236cd4ad3b2025-08-20T03:44:27ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802025-08-01141510.1161/JAHA.124.038737Digital Therapeutic Based Randomized Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy: Rationale, Design, and Baseline Characteristics of the BRIGHT TrialMario Enrico Canonico0Judith Hsia1Frederick A. Masoudi2Hayden B. Bosworth3Stacy Greene4Bryan C. Batch5Natia Hamilton6Thiago B. de Araujo7Matthew Jackson8Marsha Broussard9Zonda Gooden10Nicole L. Guthrie11Bjorn Hansell12Laura Matteliano‐Madu13Kara Mosesso14Mark A. Berman15Marc P. Bonaca16CPC Clinical Research Aurora CO USACPC Clinical Research Aurora CO USAAscension Health St. Louis MO USADurham Veterans Affairs Health Care System Durham NC USAAscension DePaul Research Services Center New Orleans LA USADurham Veterans Affairs Health Care System Durham NC USADurham Veterans Affairs Health Care System Durham NC USACPC Clinical Research Aurora CO USACPC Clinical Research Aurora CO USAAscension DePaul Research Services Center New Orleans LA USAAscension DePaul Research Services Center New Orleans LA USABetter Therapeutics, Inc. San Francisco CA USABetter Therapeutics, Inc. San Francisco CA USABetter Therapeutics, Inc. San Francisco CA USABetter Therapeutics, Inc. San Francisco CA USABetter Therapeutics, Inc. San Francisco CA USACPC Clinical Research Aurora CO USABackground The prevalence of type 2 diabetes continues to rise in the United States and worldwide. Although novel pharmacotherapies have shown benefits, not all patients have access to these medications and of those who do, some are unable to tolerate treatment. Behavior change is long known to be foundational for patients with cardiometabolic disease due to its direct positive impact on health outcomes. Cognitive behavioral therapy delivered by a digital therapeutic has the potential to address access to behavioral therapy for patients with type 2 diabetes. Methods The BRIGHT (Digital Therapeutic Based Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy) Trial (NCT05266625) is a randomized, controlled, multicenter, pragmatic, pivotal trial with open‐label extension evaluating the hypothesis that AspyreRx improves glycemic control and cardiometabolic measures in patients with type 2 diabetes compared with a control application added to usual care across a broad range of patients in a real‐world setting. The current study objectives are to evaluate the efficacy and safety of AspyreRx at 90 and 180 days compared with a control group and to assess the long‐term effectiveness, safety, and impact on health care and medication use over long‐term follow up. Conclusions The AspyreRx digital therapeutic is a Food and Drug Administration approved therapy for patients with type 2 diabetes. Although its efficacy for lowering hemoglobin A1C at 90 days was demonstrated, opportunities remain to better understand the long‐term effects and the effectiveness and safety in a broader and more diverse real‐world environment. BRIGHT is designed to evaluate these questions using a virtual, decentralized, model and include a diverse site mix designed to better understand real‐world effectiveness and generalizability.https://www.ahajournals.org/doi/10.1161/JAHA.124.038737AspyreRxBT‐001digital therapeuticslifestyle managementtype 2 diabetes |
| spellingShingle | Mario Enrico Canonico Judith Hsia Frederick A. Masoudi Hayden B. Bosworth Stacy Greene Bryan C. Batch Natia Hamilton Thiago B. de Araujo Matthew Jackson Marsha Broussard Zonda Gooden Nicole L. Guthrie Bjorn Hansell Laura Matteliano‐Madu Kara Mosesso Mark A. Berman Marc P. Bonaca Digital Therapeutic Based Randomized Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy: Rationale, Design, and Baseline Characteristics of the BRIGHT Trial Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease AspyreRx BT‐001 digital therapeutics lifestyle management type 2 diabetes |
| title | Digital Therapeutic Based Randomized Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy: Rationale, Design, and Baseline Characteristics of the BRIGHT Trial |
| title_full | Digital Therapeutic Based Randomized Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy: Rationale, Design, and Baseline Characteristics of the BRIGHT Trial |
| title_fullStr | Digital Therapeutic Based Randomized Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy: Rationale, Design, and Baseline Characteristics of the BRIGHT Trial |
| title_full_unstemmed | Digital Therapeutic Based Randomized Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy: Rationale, Design, and Baseline Characteristics of the BRIGHT Trial |
| title_short | Digital Therapeutic Based Randomized Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy: Rationale, Design, and Baseline Characteristics of the BRIGHT Trial |
| title_sort | digital therapeutic based randomized investigation to improve glycemic control in patients with type 2 diabetes and residual hyperglycemia on stable medical therapy rationale design and baseline characteristics of the bright trial |
| topic | AspyreRx BT‐001 digital therapeutics lifestyle management type 2 diabetes |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.124.038737 |
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