Katharine Barnard-Kelly, Florian Thienel, Julia K Mader, Nick Oliver, Edward Franek, Iris Vesper, Nicole Dagenbach, Gerhard Vogt, Tobias Etter, Thomas Künsting
{"title":"一项三臂随机对照研究，比较 1 型糖尿病患者使用持续皮下注射胰岛素还是每天多次注射胰岛素的患者报告结果。","authors":"Katharine Barnard-Kelly, Florian Thienel, Julia K Mader, Nick Oliver, Edward Franek, Iris Vesper, Nicole Dagenbach, Gerhard Vogt, Tobias Etter, Thomas Künsting","doi":"10.1177/19322968241234055","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The aim of this study was to compare patient-reported outcomes (PROs) in people with type 1 diabetes using either continuous subcutaneous insulin infusion (CSII) with two different insulin patch pumps or multiple daily injections (MDIs).</p><p><strong>Materials and methods: </strong>In this randomized three-arm study, people with type 1 diabetes on MDI therapy were included and used either MDI, the Accu-Chek Solo micropump system (Solo) or Omnipod for 26 weeks. From weeks 26 to 39, all participants used CSII with Solo. Patient-reported outcomes were assessed using the diabetes technology questionnaire (DTQ); in addition, HbA<sub>1c</sub> values were measured.</p><p><strong>Results: </strong>Overall, 181 participants were randomized (61 MDI arm, 62 Solo arm, 58 Omnipod arm) and 142 completed the study. After 26 weeks in the study, the DTQ \"change\" score in the Solo group (105.9 [100.6-111.2]; baseline-adjusted mean [95% confidence interval]) was significantly higher than in the MDI group (94.8 [89.6-100.0]) (<i>P</i> = .001). The comparison between the Solo group (105.1 [99.1-111.1]) and the Omnipod group (108.7 [103.1-114.4]) showed no significant differences (<i>P</i> = .382). HbA<sub>1c</sub> increased by 0.2% ± 0.7% in the MDI group and decreased in both pump groups (Solo group -0.2% ± 0.8% and Omnipod group -0.1% ± 0.8%). Differences in HbA<sub>1c</sub> between the Solo group and the MDI group were significant (<i>P</i> = .009), but not between the Solo group and the Omnipod group (<i>P</i> = .896).</p><p><strong>Conclusions: </strong>This study showed that switching from MDI to CSII improves both psychosocial well-being and physiological outcomes. Furthermore, there were no substantial differences between the established and the recently released patch pump. Trial registration at www.</p><p><strong>Clinicaltrials: </strong>gov is NCT03478969.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1310-1316"},"PeriodicalIF":3.7000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11571373/pdf/","citationCount":"0","resultStr":"{\"title\":\"A Three-Arm Randomized Controlled Study Comparing Patient-Reported Outcomes in People With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion or Multiple Daily Injections.\",\"authors\":\"Katharine Barnard-Kelly, Florian Thienel, Julia K Mader, Nick Oliver, Edward Franek, Iris Vesper, Nicole Dagenbach, Gerhard Vogt, Tobias Etter, Thomas Künsting\",\"doi\":\"10.1177/19322968241234055\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The aim of this study was to compare patient-reported outcomes (PROs) in people with type 1 diabetes using either continuous subcutaneous insulin infusion (CSII) with two different insulin patch pumps or multiple daily injections (MDIs).</p><p><strong>Materials and methods: </strong>In this randomized three-arm study, people with type 1 diabetes on MDI therapy were included and used either MDI, the Accu-Chek Solo micropump system (Solo) or Omnipod for 26 weeks. From weeks 26 to 39, all participants used CSII with Solo. Patient-reported outcomes were assessed using the diabetes technology questionnaire (DTQ); in addition, HbA<sub>1c</sub> values were measured.</p><p><strong>Results: </strong>Overall, 181 participants were randomized (61 MDI arm, 62 Solo arm, 58 Omnipod arm) and 142 completed the study. After 26 weeks in the study, the DTQ \\\"change\\\" score in the Solo group (105.9 [100.6-111.2]; baseline-adjusted mean [95% confidence interval]) was significantly higher than in the MDI group (94.8 [89.6-100.0]) (<i>P</i> = .001). The comparison between the Solo group (105.1 [99.1-111.1]) and the Omnipod group (108.7 [103.1-114.4]) showed no significant differences (<i>P</i> = .382). HbA<sub>1c</sub> increased by 0.2% ± 0.7% in the MDI group and decreased in both pump groups (Solo group -0.2% ± 0.8% and Omnipod group -0.1% ± 0.8%). Differences in HbA<sub>1c</sub> between the Solo group and the MDI group were significant (<i>P</i> = .009), but not between the Solo group and the Omnipod group (<i>P</i> = .896).</p><p><strong>Conclusions: </strong>This study showed that switching from MDI to CSII improves both psychosocial well-being and physiological outcomes. Furthermore, there were no substantial differences between the established and the recently released patch pump. 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A Three-Arm Randomized Controlled Study Comparing Patient-Reported Outcomes in People With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion or Multiple Daily Injections.
Background: The aim of this study was to compare patient-reported outcomes (PROs) in people with type 1 diabetes using either continuous subcutaneous insulin infusion (CSII) with two different insulin patch pumps or multiple daily injections (MDIs).
Materials and methods: In this randomized three-arm study, people with type 1 diabetes on MDI therapy were included and used either MDI, the Accu-Chek Solo micropump system (Solo) or Omnipod for 26 weeks. From weeks 26 to 39, all participants used CSII with Solo. Patient-reported outcomes were assessed using the diabetes technology questionnaire (DTQ); in addition, HbA1c values were measured.
Results: Overall, 181 participants were randomized (61 MDI arm, 62 Solo arm, 58 Omnipod arm) and 142 completed the study. After 26 weeks in the study, the DTQ "change" score in the Solo group (105.9 [100.6-111.2]; baseline-adjusted mean [95% confidence interval]) was significantly higher than in the MDI group (94.8 [89.6-100.0]) (P = .001). The comparison between the Solo group (105.1 [99.1-111.1]) and the Omnipod group (108.7 [103.1-114.4]) showed no significant differences (P = .382). HbA1c increased by 0.2% ± 0.7% in the MDI group and decreased in both pump groups (Solo group -0.2% ± 0.8% and Omnipod group -0.1% ± 0.8%). Differences in HbA1c between the Solo group and the MDI group were significant (P = .009), but not between the Solo group and the Omnipod group (P = .896).
Conclusions: This study showed that switching from MDI to CSII improves both psychosocial well-being and physiological outcomes. Furthermore, there were no substantial differences between the established and the recently released patch pump. Trial registration at www.
期刊介绍：
The Journal of Diabetes Science and Technology (JDST) is a bi-monthly, peer-reviewed scientific journal published by the Diabetes Technology Society. JDST covers scientific and clinical aspects of diabetes technology including glucose monitoring, insulin and metabolic peptide delivery, the artificial pancreas, digital health, precision medicine, social media, cybersecurity, software for modeling, physiologic monitoring, technology for managing obesity, and diagnostic tests of glycation. The journal also covers the development and use of mobile applications and wireless communication, as well as bioengineered tools such as MEMS, new biomaterials, and nanotechnology to develop new sensors. Articles in JDST cover both basic research and clinical applications of technologies being developed to help people with diabetes.
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