Efficacy and safety of Android artificial pancreas system use at home among adults with type 1 diabetes mellitus in China: protocol of a 26-week, free-living, randomised, open-label, two-arm, two-phase, crossover trial
Introduction Do-it-yourself artificial pancreas system (DIY APS) is built using commercially available insulin pump, continuous glucose monitoring (CGM) and an open-source algorithm. Compared with commercial products, DIY systems are affordable, allow personalised settings and provide updated algori...
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BMJ Publishing Group
2023-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/8/e073263.full |
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| author | Hongrong Deng Daizhi Yang Wen Xu Jinhua Yan Ping Ling Mengyun Lei Beisi Lin Zhigu Liu Xubin Yang Jing Lv |
| author_facet | Hongrong Deng Daizhi Yang Wen Xu Jinhua Yan Ping Ling Mengyun Lei Beisi Lin Zhigu Liu Xubin Yang Jing Lv |
| author_sort | Hongrong Deng |
| collection | DOAJ |
| description | Introduction Do-it-yourself artificial pancreas system (DIY APS) is built using commercially available insulin pump, continuous glucose monitoring (CGM) and an open-source algorithm. Compared with commercial products, DIY systems are affordable, allow personalised settings and provide updated algorithms, making them a more promising therapy for most patients with type 1 diabetes mellitus (T1DM). Many small and self-reported observational studies have found that their real-world use was associated with potential metabolic and psychological benefits. However, rigorous-designed studies are urgently needed to confirm its efficacy and safety.Methods and analysis In this 26-week randomised, open-label, two-arm, two-phase, crossover trial, participants aged 18–75 years, with T1DM and glycated haemoglobin (HbA1c) 7–11%, will use AndroidAPS during one 12-week period and sensor-augmented pump during another 12-week period. This study will recruit at least 24 randomised participants. AndroidAPS consists of three components: (1) real-time CGM; (2) insulin pump; (3) AndroidAPS algorithm implemented in Android smartphone. The primary endpoint is time in range (3.9–10.0 mmol/L) derived from CGM. The main secondary endpoints include percentage of sensor glucose values below, within and above target range; mean sensor glucose value; measures of glycaemic variability and centralised HbA1c. Safety endpoints mainly include the frequency of hypoglycaemia events, diabetic ketoacidosis and other serious adverse events.Ethics and dissemination This study has been approved by the Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University. There will be verbal and written information regarding the trial given to each participant. The study will be disseminated through peer-reviewed publications and conference presentations.Overall status Recruiting.Study start 11 February 2023.Primary completion 31 July 2024.Trial registration number ClinicalTrials.gov Registry (NCT05726461). |
| format | Article |
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| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-08-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-a9ec9f62cab34489b9c048474f0ca2d42024-11-14T13:35:08ZengBMJ Publishing GroupBMJ Open2044-60552023-08-0113810.1136/bmjopen-2023-073263Efficacy and safety of Android artificial pancreas system use at home among adults with type 1 diabetes mellitus in China: protocol of a 26-week, free-living, randomised, open-label, two-arm, two-phase, crossover trialHongrong Deng0Daizhi Yang1Wen Xu2Jinhua Yan3Ping Ling4Mengyun Lei5Beisi Lin6Zhigu Liu7Xubin Yang8Jing Lv9Department of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, ChinaDepartment of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China4Eli Lilly and Company, Indianapolis, United States of AmericaDepartment of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, ChinaDepartment of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, ChinaDepartment of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, ChinaDepartment of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, ChinaDepartment of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, ChinaDepartment of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, ChinaDepartment of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, ChinaIntroduction Do-it-yourself artificial pancreas system (DIY APS) is built using commercially available insulin pump, continuous glucose monitoring (CGM) and an open-source algorithm. Compared with commercial products, DIY systems are affordable, allow personalised settings and provide updated algorithms, making them a more promising therapy for most patients with type 1 diabetes mellitus (T1DM). Many small and self-reported observational studies have found that their real-world use was associated with potential metabolic and psychological benefits. However, rigorous-designed studies are urgently needed to confirm its efficacy and safety.Methods and analysis In this 26-week randomised, open-label, two-arm, two-phase, crossover trial, participants aged 18–75 years, with T1DM and glycated haemoglobin (HbA1c) 7–11%, will use AndroidAPS during one 12-week period and sensor-augmented pump during another 12-week period. This study will recruit at least 24 randomised participants. AndroidAPS consists of three components: (1) real-time CGM; (2) insulin pump; (3) AndroidAPS algorithm implemented in Android smartphone. The primary endpoint is time in range (3.9–10.0 mmol/L) derived from CGM. The main secondary endpoints include percentage of sensor glucose values below, within and above target range; mean sensor glucose value; measures of glycaemic variability and centralised HbA1c. Safety endpoints mainly include the frequency of hypoglycaemia events, diabetic ketoacidosis and other serious adverse events.Ethics and dissemination This study has been approved by the Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University. There will be verbal and written information regarding the trial given to each participant. The study will be disseminated through peer-reviewed publications and conference presentations.Overall status Recruiting.Study start 11 February 2023.Primary completion 31 July 2024.Trial registration number ClinicalTrials.gov Registry (NCT05726461).https://bmjopen.bmj.com/content/13/8/e073263.full |
| spellingShingle | Hongrong Deng Daizhi Yang Wen Xu Jinhua Yan Ping Ling Mengyun Lei Beisi Lin Zhigu Liu Xubin Yang Jing Lv Efficacy and safety of Android artificial pancreas system use at home among adults with type 1 diabetes mellitus in China: protocol of a 26-week, free-living, randomised, open-label, two-arm, two-phase, crossover trial BMJ Open |
| title | Efficacy and safety of Android artificial pancreas system use at home among adults with type 1 diabetes mellitus in China: protocol of a 26-week, free-living, randomised, open-label, two-arm, two-phase, crossover trial |
| title_full | Efficacy and safety of Android artificial pancreas system use at home among adults with type 1 diabetes mellitus in China: protocol of a 26-week, free-living, randomised, open-label, two-arm, two-phase, crossover trial |
| title_fullStr | Efficacy and safety of Android artificial pancreas system use at home among adults with type 1 diabetes mellitus in China: protocol of a 26-week, free-living, randomised, open-label, two-arm, two-phase, crossover trial |
| title_full_unstemmed | Efficacy and safety of Android artificial pancreas system use at home among adults with type 1 diabetes mellitus in China: protocol of a 26-week, free-living, randomised, open-label, two-arm, two-phase, crossover trial |
| title_short | Efficacy and safety of Android artificial pancreas system use at home among adults with type 1 diabetes mellitus in China: protocol of a 26-week, free-living, randomised, open-label, two-arm, two-phase, crossover trial |
| title_sort | efficacy and safety of android artificial pancreas system use at home among adults with type 1 diabetes mellitus in china protocol of a 26 week free living randomised open label two arm two phase crossover trial |
| url | https://bmjopen.bmj.com/content/13/8/e073263.full |
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