Pub Date : 2026-01-01Epub Date: 2025-10-14DOI: 10.1177/19322968251383919
Robert Richardson
{"title":"Anaglycemia and Cataglycemia: Proposed Terminology for Glucose Dynamics.","authors":"Robert Richardson","doi":"10.1177/19322968251383919","DOIUrl":"10.1177/19322968251383919","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":"20 1","pages":"233-234"},"PeriodicalIF":3.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12521145/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145911737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-05-28DOI: 10.1177/19322968251338863
Cathy Jones, Amy E Morrison, Grace Grudgings, Sarah Evans, Malak Hamza, Sheena Thayyil, Jolyon Dales, Harriet Morgan, Ian Lawrence, Helena Maybury, Pratik Choudhary, Claire L Meek
Background: Hybrid closed loop (HCL) technology is now standard of care for women with type 1 diabetes in pregnancy in the United Kingdom, but there is minimal evidence to guide HCL use in the preconception period, peripartum, and postnatally. We used real-world data to assess whether HCL use offered benefits upon glycemia in the preconception, peripartum, and postnatal periods.
Methods: This single-center retrospective observational study assesses the effect of HCL use upon HbA1c and continuous glucose monitoring (CGM) metrics, including time-in-range (TIR; 3.9-10.0 mmol/L; 72-180 mg/dL) or pregnancy time-in-range (TIRp; 3.5-7.8 mmol/L; 63-140 mg/dL) before (n = 46), during (n = 21), and after (n = 25) pregnancy. Data (mean (SD)) were analyzed using paired t tests (limit P < .05).
Results: Preconception initiation of HCL was associated with a reduction of HbA1c from 62.4 (14.0) to 54.2 (7.7) mmol/mol at three to six months (7.9 (1.3) to 7.1 (0.7) %; P < .0001). The TIR increased from 49% at baseline to 65% at one week (P < .001) and 72% at six months (P < .001) after initiation. Time-below-range (TBR) fell from 3.2% at baseline to 2.1% at one week (P = .006) and 2.1% at three months (P = .042). Pregnancy initiation of HCL was associated with a reduction of HbA1c from 61.2 (14.6) to 48.1 (8.6) mmol/mol at three months (n = 36; P < .0001) and increased TIRp (37% baseline to 57% after one week; P < .0001). Patients using HCL postnatally at one month had TIR 70% and TBR 1.8%.
Conclusions: When started preconception or in pregnancy, HCL significantly reduces HbA1c at three months and improves TIR by 15% to 20% within one week.
{"title":"Effect of Automated Insulin Delivery Using Hybrid Closed Loops in the Preconception, Peripartum and Postnatal Periods for Women With Type 1 Diabetes.","authors":"Cathy Jones, Amy E Morrison, Grace Grudgings, Sarah Evans, Malak Hamza, Sheena Thayyil, Jolyon Dales, Harriet Morgan, Ian Lawrence, Helena Maybury, Pratik Choudhary, Claire L Meek","doi":"10.1177/19322968251338863","DOIUrl":"10.1177/19322968251338863","url":null,"abstract":"<p><strong>Background: </strong>Hybrid closed loop (HCL) technology is now standard of care for women with type 1 diabetes in pregnancy in the United Kingdom, but there is minimal evidence to guide HCL use in the preconception period, peripartum, and postnatally. We used real-world data to assess whether HCL use offered benefits upon glycemia in the preconception, peripartum, and postnatal periods.</p><p><strong>Methods: </strong>This single-center retrospective observational study assesses the effect of HCL use upon HbA1c and continuous glucose monitoring (CGM) metrics, including time-in-range (TIR; 3.9-10.0 mmol/L; 72-180 mg/dL) or pregnancy time-in-range (TIRp; 3.5-7.8 mmol/L; 63-140 mg/dL) before (n = 46), during (n = 21), and after (n = 25) pregnancy. Data (mean (SD)) were analyzed using paired <i>t</i> tests (limit <i>P</i> < .05).</p><p><strong>Results: </strong>Preconception initiation of HCL was associated with a reduction of HbA1c from 62.4 (14.0) to 54.2 (7.7) mmol/mol at three to six months (7.9 (1.3) to 7.1 (0.7) %; <i>P</i> < .0001). The TIR increased from 49% at baseline to 65% at one week (<i>P</i> < .001) and 72% at six months (<i>P</i> < .001) after initiation. Time-below-range (TBR) fell from 3.2% at baseline to 2.1% at one week (<i>P</i> = .006) and 2.1% at three months (<i>P</i> = .042). Pregnancy initiation of HCL was associated with a reduction of HbA1c from 61.2 (14.6) to 48.1 (8.6) mmol/mol at three months (n = 36; <i>P</i> < .0001) and increased TIRp (37% baseline to 57% after one week; <i>P</i> < .0001). Patients using HCL postnatally at one month had TIR 70% and TBR 1.8%.</p><p><strong>Conclusions: </strong>When started preconception or in pregnancy, HCL significantly reduces HbA1c at three months and improves TIR by 15% to 20% within one week.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"23-30"},"PeriodicalIF":3.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12119519/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144159072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2024-08-14DOI: 10.1177/19322968241267820
Michael C Riddell, Dana M Lewis, Lauren V Turner, Rayhan A Lal, Arsalan Shahid, Dessi P Zaharieva
Automated insulin delivery (AID) systems enhance glucose management by lowering mean glucose level, reducing hyperglycemia, and minimizing hypoglycemia. One feature of most AID systems is that they allow the user to view "insulin on board" (IOB) to help confirm a recent bolus and limit insulin stacking. This metric, along with viewing glucose concentrations from a continuous glucose monitoring system, helps the user understand bolus insulin action and the future "threat" of hypoglycemia. However, the current presentation of IOB in AID systems can be misleading, as it does not reflect true insulin action or automatic, dynamic insulin adjustments. This commentary examines the evolution of IOB from a bolus-specific metric to its contemporary use in AID systems, highlighting its limitations in capturing real-time insulin modulation during varying physiological states.
胰岛素自动给药系统(AID)通过降低平均血糖水平、减少高血糖和低血糖来加强血糖管理。大多数 AID 系统的一个特点是允许用户查看 "机载胰岛素"(IOB),以帮助确认最近的胰岛素注射并限制胰岛素叠加。这一指标以及通过连续血糖监测系统查看葡萄糖浓度,可帮助用户了解栓注胰岛素的作用以及未来低血糖的 "威胁"。然而,目前在 AID 系统中显示的 IOB 可能会产生误导,因为它并不能反映真实的胰岛素作用或自动、动态的胰岛素调整。这篇评论探讨了 IOB 从栓剂特异性指标到目前在 AID 系统中使用的演变过程,强调了它在捕捉不同生理状态下的实时胰岛素调节方面的局限性。
{"title":"Refining Insulin on Board with netIOB for Automated Insulin Delivery.","authors":"Michael C Riddell, Dana M Lewis, Lauren V Turner, Rayhan A Lal, Arsalan Shahid, Dessi P Zaharieva","doi":"10.1177/19322968241267820","DOIUrl":"10.1177/19322968241267820","url":null,"abstract":"<p><p>Automated insulin delivery (AID) systems enhance glucose management by lowering mean glucose level, reducing hyperglycemia, and minimizing hypoglycemia. One feature of most AID systems is that they allow the user to view \"insulin on board\" (IOB) to help confirm a recent bolus and limit insulin stacking. This metric, along with viewing glucose concentrations from a continuous glucose monitoring system, helps the user understand bolus insulin action and the future \"threat\" of hypoglycemia. However, the current presentation of IOB in AID systems can be misleading, as it does not reflect true insulin action or automatic, dynamic insulin adjustments. This commentary examines the evolution of IOB from a bolus-specific metric to its contemporary use in AID systems, highlighting its limitations in capturing real-time insulin modulation during varying physiological states.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"193-200"},"PeriodicalIF":3.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11571556/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141982453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2024-12-21DOI: 10.1177/19322968241306129
Alessandra T Ayers, Cindy N Ho, Emma Friedman, Juan Espinoza, Shahid N Shah, David C Klonoff
The Diabetes Research Hub (DRH) is a centralized data management system and repository that will revolutionize how diabetes data are gathered, stored, analyzed, and utilized for research. By harnessing advanced analytics for large datasets, the DRH will support a nuanced understanding of physiological patterns and treatment effectiveness, ultimately advancing diabetes management and patient outcomes. This is an opportune time for researchers who are collecting continuous glucose data and related physiological data sources, to leverage the capabilities of the DRH to enhance the value of their data.
{"title":"How the Diabetes Research Hub Will Modernize and Enhance Diabetes Data Utilization.","authors":"Alessandra T Ayers, Cindy N Ho, Emma Friedman, Juan Espinoza, Shahid N Shah, David C Klonoff","doi":"10.1177/19322968241306129","DOIUrl":"10.1177/19322968241306129","url":null,"abstract":"<p><p>The Diabetes Research Hub (DRH) is a centralized data management system and repository that will revolutionize how diabetes data are gathered, stored, analyzed, and utilized for research. By harnessing advanced analytics for large datasets, the DRH will support a nuanced understanding of physiological patterns and treatment effectiveness, ultimately advancing diabetes management and patient outcomes. This is an opportune time for researchers who are collecting continuous glucose data and related physiological data sources, to leverage the capabilities of the DRH to enhance the value of their data.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"3-6"},"PeriodicalIF":3.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11662337/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872346","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2024-09-23DOI: 10.1177/19322968241273845
Catriona M Farrell, Giacomo Cappon, Daniel J West, Andrea Facchinetti, Rory J McCrimmon
Aims: To assess the impact of high-intensity interval training (HIIT) on hypoglycemia frequency and duration in people with type 1 diabetes (T1D) with impaired awareness of hypoglycemia (IAH).
Methods: Post hoc analysis of four weeks of continuous glucose monitoring (CGM) data from HIT4HYPOS; a parallel-group study comparing HIIT + CGM versus no exercise + CGM in 18 participants with T1D and IAH.
Results: When compared with those participating individuals not exercising, HIIT did not increase total hypoglycemia frequency, THypo(L1) 1.44 [1.00-2.77]% versus 2.53 [1.46-4.23]%; P = .335, THypo(L2) 0.25 [0.09-0.37]% versus 0.45 [0.20-0.78]%; P = .146, HIIT + CGM versus CGM, respectively, rate (EventPerWeekHypo 5.30 [3.35-8.27] #/week vs 7.45 [3.54-10.81] #/week, P = .340) or duration (DurationHypo 33.33 [27.60-39.10] minutes vs 39.56 [31.00-48.38] minutes; P = .219, HIIT + CGM vs CGM, respectively). There was a reduction in nocturnal hypoglycemia in those who carried out HIIT, THypo(L1) 0.50 [0.13-0.97]% versus 2.45 [0.77-4.74]%; P = .076; THypo(L2) 0.00 [0.00-0.03]% versus 0.49 [0.13-0.74]%; P = .006, HIIT + CGM versus CGM, respectively.
Conclusions/interpretation: Based on CGM data collected from a real-world study of four weeks of HIIT versus no exercise in individuals with T1D and IAH, we conclude that HIIT does not increase hypoglycemia, and in fact reduces exposure to nocturnal hypoglycemia.
{"title":"HIT4HYPOS Continuous Glucose Monitoring Data Analysis: The Effects of High-Intensity Interval Training on Hypoglycemia in People With Type 1 Diabetes and Impaired Awareness of Hypoglycemia.","authors":"Catriona M Farrell, Giacomo Cappon, Daniel J West, Andrea Facchinetti, Rory J McCrimmon","doi":"10.1177/19322968241273845","DOIUrl":"10.1177/19322968241273845","url":null,"abstract":"<p><strong>Aims: </strong>To assess the impact of high-intensity interval training (HIIT) on hypoglycemia frequency and duration in people with type 1 diabetes (T1D) with impaired awareness of hypoglycemia (IAH).</p><p><strong>Methods: </strong>Post hoc analysis of four weeks of continuous glucose monitoring (CGM) data from HIT4HYPOS; a parallel-group study comparing HIIT + CGM versus no exercise + CGM in 18 participants with T1D and IAH.</p><p><strong>Results: </strong>When compared with those participating individuals not exercising, HIIT did not increase total hypoglycemia frequency, <i>T<sub>Hypo(L1)</sub></i> 1.44 [1.00-2.77]% versus 2.53 [1.46-4.23]%; <i>P</i> = .335, <i>T<sub>Hypo(L2)</sub></i> 0.25 [0.09-0.37]% versus 0.45 [0.20-0.78]%; <i>P</i> = .146, HIIT + CGM versus CGM, respectively, rate (<i>EventPerWeek<sub>Hypo</sub></i> 5.30 [3.35-8.27] #/week vs 7.45 [3.54-10.81] #/week, <i>P</i> = .340) or duration (<i>Duration<sub>Hypo</sub></i> 33.33 [27.60-39.10] minutes vs 39.56 [31.00-48.38] minutes; <i>P</i> = .219, HIIT + CGM vs CGM, respectively). There was a reduction in nocturnal hypoglycemia in those who carried out HIIT, <i>T<sub>Hypo</sub></i><sub>(L1)</sub> 0.50 [0.13-0.97]% versus 2.45 [0.77-4.74]%; <i>P</i> = .076; <i>T<sub>Hypo</sub></i><sub>(L2)</sub> 0.00 [0.00-0.03]% versus 0.49 [0.13-0.74]%; <i>P</i> = .006, HIIT + CGM versus CGM, respectively.</p><p><strong>Conclusions/interpretation: </strong>Based on CGM data collected from a real-world study of four weeks of HIIT versus no exercise in individuals with T1D and IAH, we conclude that HIIT does not increase hypoglycemia, and in fact reduces exposure to nocturnal hypoglycemia.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"167-172"},"PeriodicalIF":3.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11571604/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142288370","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2024-08-18DOI: 10.1177/19322968241274796
Lutz Heinemann, Jochen Sieber, Bernd Kulzer
Subcutaneous insulin administration has come a long way; pens that are connected to smartphones/cloud enable data transfer about insulin dosing. The usage of detailed dosing information in a smart way can support the optimization of insulin therapy in many ways. This review discusses terminology aspects that are relevant to the optimal usage of this novel option for insulin administration. Taking such aspects into account might also be crucial to improving the uptake of these medical products. In contrast to systems for automated insulin delivery, people with diabetes have to administer the insulin dose themselves; the technology can only support them. Combining smart pens with systems for continuous glucose monitoring provides solutions that are close to an automated solution, but are more discrete and associated with lower costs.
{"title":"Connected Pens or Smart Pens: Technology Needs Context.","authors":"Lutz Heinemann, Jochen Sieber, Bernd Kulzer","doi":"10.1177/19322968241274796","DOIUrl":"10.1177/19322968241274796","url":null,"abstract":"<p><p>Subcutaneous insulin administration has come a long way; pens that are connected to smartphones/cloud enable data transfer about insulin dosing. The usage of detailed dosing information in a smart way can support the optimization of insulin therapy in many ways. This review discusses terminology aspects that are relevant to the optimal usage of this novel option for insulin administration. Taking such aspects into account might also be crucial to improving the uptake of these medical products. In contrast to systems for automated insulin delivery, people with diabetes have to administer the insulin dose themselves; the technology can only support them. Combining smart pens with systems for continuous glucose monitoring provides solutions that are close to an automated solution, but are more discrete and associated with lower costs.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"184-192"},"PeriodicalIF":3.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11571358/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142000026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-10-21DOI: 10.1177/19322968251391823
Agatha F Scheideman, Mandy M Shao, Simona Carini, Viral N Shah, Alaina P Vidmar, Sarah D Corathers, Eric Williams, Lawrence Lett, Mark Clements, David C Klonoff, Juan Espinoza
{"title":"iCoDE-2 September 18, 2025 Steering Committee Final Meeting Summary Report.","authors":"Agatha F Scheideman, Mandy M Shao, Simona Carini, Viral N Shah, Alaina P Vidmar, Sarah D Corathers, Eric Williams, Lawrence Lett, Mark Clements, David C Klonoff, Juan Espinoza","doi":"10.1177/19322968251391823","DOIUrl":"10.1177/19322968251391823","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"227-228"},"PeriodicalIF":3.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12546080/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145345645","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-11-17DOI: 10.1177/19322968251394046
Yoonhee Kim, Roberto Crackel, Hye Soo Cho, Wenda Tu, Yun Wang
{"title":"Beyond Time in Range: Hidden Statistical Challenges of Continuous Glucose Monitoring Data in Diabetes Drug Development.","authors":"Yoonhee Kim, Roberto Crackel, Hye Soo Cho, Wenda Tu, Yun Wang","doi":"10.1177/19322968251394046","DOIUrl":"10.1177/19322968251394046","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"229-230"},"PeriodicalIF":3.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12623221/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145541086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-11-27DOI: 10.1177/19322968251387149
Amanda Liu, Amanda Phoenix, Charnicia Huggins, Vivien Leung
{"title":"Expanding Primary Care Prescribing of Continuous Glucose Monitors Through an Electronic Health Record-Based Order Set.","authors":"Amanda Liu, Amanda Phoenix, Charnicia Huggins, Vivien Leung","doi":"10.1177/19322968251387149","DOIUrl":"10.1177/19322968251387149","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"231-232"},"PeriodicalIF":3.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12660116/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145633946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2024-10-06DOI: 10.1177/19322968241268547
Erika A Petersen, Thomas G Stauss, James A Scowcroft, Michael J Jaasma, Deborah R Edgar, Judith L White, Shawn M Sills, Kasra Amirdelfan, Maged N Guirguis, Jijun Xu, Cong Yu, Ali Nairizi, Denis G Patterson, Michael J Creamer, Vincent Galan, Richard H Bundschu, Neel D Mehta, Dawood Sayed, Shivanand P Lad, David J DiBenedetto, Khalid A Sethi, Johnathan H Goree, Matthew T Bennett, Nathan J Harrison, Atef F Israel, Paul Chang, Paul W Wu, Charles E Argoff, Christian E Nasr, Rod S Taylor, David L Caraway, Nagy A Mekhail
Background: The SENZA-PDN study evaluated high-frequency 10-kHz spinal cord stimulation (SCS) for the treatment of painful diabetic neuropathy (PDN). Over 24 months, 10-kHz SCS provided sustained pain relief and improved health-related quality of life. This report presents additional outcomes from the SENZA-PDN study, focusing on diabetes-related pain and quality of life outcomes.
Methods: The SENZA-PDN study randomized 216 participants with refractory PDN to receive either conventional medical management (CMM) or 10-kHz SCS plus CMM (10-kHz SCS + CMM), allowing crossover after six months if pain relief was insufficient. Postimplantation assessments at 24 months were completed by 142 participants with a permanent 10-kHz SCS implant, comprising 84 initial and 58 crossover recipients. Measures included the Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN), Diabetes-Related Quality of Life (DQOL), Global Assessment of Functioning (GAF), and treatment satisfaction.
Results: Over 24 months, 10-kHz SCS treatment significantly reduced pain severity by 66.9% (P < .001; BPI-DPN) and pain interference with mood and daily activities by 65.8% (P < .001; BPI-DPN). Significant improvements were also observed in overall DQOL score (P < .001) and GAF score (P < .001), and 91.5% of participants reported satisfaction with treatment.
Conclusions: High-frequency 10-kHz SCS significantly decreased pain severity and provided additional clinically meaningful improvements in DQOL and overall functioning for patients with PDN. The robust and sustained benefits over 24 months, coupled with high participant satisfaction, highlight that 10-kHz SCS is an efficacious and comprehensive therapy for patients with PDN.
{"title":"High-Frequency 10-kHz Spinal Cord Stimulation Provides Long-term (24-Month) Improvements in Diabetes-Related Pain and Quality of Life for Patients with Painful Diabetic Neuropathy.","authors":"Erika A Petersen, Thomas G Stauss, James A Scowcroft, Michael J Jaasma, Deborah R Edgar, Judith L White, Shawn M Sills, Kasra Amirdelfan, Maged N Guirguis, Jijun Xu, Cong Yu, Ali Nairizi, Denis G Patterson, Michael J Creamer, Vincent Galan, Richard H Bundschu, Neel D Mehta, Dawood Sayed, Shivanand P Lad, David J DiBenedetto, Khalid A Sethi, Johnathan H Goree, Matthew T Bennett, Nathan J Harrison, Atef F Israel, Paul Chang, Paul W Wu, Charles E Argoff, Christian E Nasr, Rod S Taylor, David L Caraway, Nagy A Mekhail","doi":"10.1177/19322968241268547","DOIUrl":"10.1177/19322968241268547","url":null,"abstract":"<p><strong>Background: </strong>The SENZA-PDN study evaluated high-frequency 10-kHz spinal cord stimulation (SCS) for the treatment of painful diabetic neuropathy (PDN). Over 24 months, 10-kHz SCS provided sustained pain relief and improved health-related quality of life. This report presents additional outcomes from the SENZA-PDN study, focusing on diabetes-related pain and quality of life outcomes.</p><p><strong>Methods: </strong>The SENZA-PDN study randomized 216 participants with refractory PDN to receive either conventional medical management (CMM) or 10-kHz SCS plus CMM (10-kHz SCS + CMM), allowing crossover after six months if pain relief was insufficient. Postimplantation assessments at 24 months were completed by 142 participants with a permanent 10-kHz SCS implant, comprising 84 initial and 58 crossover recipients. Measures included the Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN), Diabetes-Related Quality of Life (DQOL), Global Assessment of Functioning (GAF), and treatment satisfaction.</p><p><strong>Results: </strong>Over 24 months, 10-kHz SCS treatment significantly reduced pain severity by 66.9% (<i>P</i> < .001; BPI-DPN) and pain interference with mood and daily activities by 65.8% (<i>P</i> < .001; BPI-DPN). Significant improvements were also observed in overall DQOL score (<i>P</i> < .001) and GAF score (<i>P</i> < .001), and 91.5% of participants reported satisfaction with treatment.</p><p><strong>Conclusions: </strong>High-frequency 10-kHz SCS significantly decreased pain severity and provided additional clinically meaningful improvements in DQOL and overall functioning for patients with PDN. The robust and sustained benefits over 24 months, coupled with high participant satisfaction, highlight that 10-kHz SCS is an efficacious and comprehensive therapy for patients with PDN.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"124-133"},"PeriodicalIF":3.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11571607/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142377876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}