Alzbeta Santova, Vit Neuman, Lukas Plachy, Shenali Anne Amaratunga, Marketa Pavlikova, Martina Romanova, Petra Konecna, David Neumann, Kamila Kocourkova, Jiri Strnadel, Renata Pomahacova, Petra Venhacova, Jaroslav Skvor, Barbora Obermannova, Stepanka Pruhova, Ondrej Cinek, Zdenek Sumnik
{"title":"The Longer, the Better: Continuous Glucose Monitoring Use for ≥90% Is Superior to 70%-89% in Achieving Tighter Glycemic Outcomes in Children with Type 1 Diabetes.","authors":"Alzbeta Santova, Vit Neuman, Lukas Plachy, Shenali Anne Amaratunga, Marketa Pavlikova, Martina Romanova, Petra Konecna, David Neumann, Kamila Kocourkova, Jiri Strnadel, Renata Pomahacova, Petra Venhacova, Jaroslav Skvor, Barbora Obermannova, Stepanka Pruhova, Ondrej Cinek, Zdenek Sumnik","doi":"10.1089/dia.2024.0472","DOIUrl":"https://doi.org/10.1089/dia.2024.0472","url":null,"abstract":"<p><p><b><i>Objective:</i></b> The recommended threshold for the time spent on continuous glucose monitoring (CGM) is established at 70%. However, glucose outcomes in children with type 1 diabetes (CwD) using CGM for a different proportion of time within this threshold have not been evaluated yet. The study aims to compare glycemic parameters among CwD who spent 70%-89% and ≥90% on CGM using the population-wide data from the Czech national pediatric diabetes registry ČENDA. <b><i>Methods:</i></b> CwD aged <19 years who used real-time CGM >70% of the time and did not change the type of therapy throughout the year 2023 were included and divided into two groups based on the time they spent on CGM-70%-89% versus ≥90%. HbA1c, times in standard glycemic ranges, mean glucose, and coefficient of variability (CV) were compared between the groups and by treatment modalities. <b><i>Results:</i></b> Data from 1977 CwD (1035 males and 942 females) were evaluated. Among them, 404 participants (20.4%) used CGM 70%-89% of the time, and 1573 participants (79.6%) ≥90% of the time. Compared with the 70-89% group, the ≥90% CGM users achieved significantly lower HbA1c levels (51 mmol/mol, 6.8% vs. 58 mmol/mol, 7.4%, <i>P</i> < 0.001), higher time in range (72% vs. 60%, <i>P</i> < 0.001), and lower mean glucose and CV (8.1 mmol/L, 146 mg/dL vs. 9.1 mmol/L, 164 mg/dL and 37% vs. 40%, respectively, both <i>P</i> < 0.001). Analogous results were seen irrespective of the treatment modality. The differences persisted after propensity score adjustment. <b><i>Conclusion:</i></b> CGM use for ≥90% is associated with tighter glycemic control compared with 70%-89% use. Therefore, it is essential to motivate CwD to use CGM for the longest possible time and search for suitable options to overcome barriers in uninterrupted CGM monitoring.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Craig Vandervelden, Brent Lockee, Mitchell Barnes, Erin M Tallon, David D Williams, Anna Kahkoska, Angelica Cristello Sarteau, Susana R Patton, Rona Y Sonabend, Jacob D Kohlenberg, Mark A Clements
{"title":"Predicting and Ranking Diabetic Ketoacidosis Risk among Youth with Type 1 Diabetes with a Clinic-to-Clinic Transferrable Machine Learning Model.","authors":"Craig Vandervelden, Brent Lockee, Mitchell Barnes, Erin M Tallon, David D Williams, Anna Kahkoska, Angelica Cristello Sarteau, Susana R Patton, Rona Y Sonabend, Jacob D Kohlenberg, Mark A Clements","doi":"10.1089/dia.2024.0484","DOIUrl":"https://doi.org/10.1089/dia.2024.0484","url":null,"abstract":"<p><p><b><i>Aim:</i></b> To use electronic health record (EHR) data to develop a scalable and transferrable model to predict 6-month risk for diabetic ketoacidosis (DKA)-related hospitalization or emergency care in youth with type 1 diabetes (T1D). <b><i>Method:</i></b> To achieve a sharable predictive model, we engineered features using EHR data mapped to the T1D Exchange Quality Improvement Collaborative's (T1DX-QI) data schema used by 60+ U.S. diabetes centers and chose a compact set of 15 features (e.g., demographics, factors related to diabetes management, etc.) to yield \"explainable AI\" predictions for DKA risk on a 6-month horizon. We used an ensemble of gradient-boosted, tree-based models trained on data collected from September 1, 2017 to November 1, 2022 (3097 unique patients; 24,638 clinical encounters) from a tertiary care pediatric diabetes clinic network in the Midwest USA. <b><i>Results:</i></b> We rank-ordered the top 10, 25, 50, and 100 highest-risk youth in an out-of-sample testing set, which yielded an average precision of 0.96, 0.81, 0.75, and 0.70, respectively. The lift of the model (relative to random selection) for the top 100 individuals is 19. The model identified average time between DKA episodes, time since the last DKA episode, and T1D duration as the top three features for predicting DKA risk. <b><i>Conclusions:</i></b> Our DKA risk model effectively predicts youths' relative risk of experiencing hospitalization for DKA and is readily deployable to other diabetes centers that map diabetes data to the T1DX-QI schema. This model may facilitate the development of targeted interventions for youths at the highest risk for DKA. Future work will add novel features such as device data, social determinants of health, and diabetes self-management behaviors.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930829","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Chloë Royston, Simon Bergford, Peter Calhoun, Judy Sibayan, Yue Ruan, Charlotte Boughton, Malgorzata E Wilinska, Roman Hovorka
{"title":"Safety of Options to \"Boost\" (Enhancing Insulin Infusion Rates) and \"Ease-Off\" (Reducing Insulin Infusion Rates) in CamAPS FX Hybrid Closed-Loop System: A Real-World Analysis.","authors":"Chloë Royston, Simon Bergford, Peter Calhoun, Judy Sibayan, Yue Ruan, Charlotte Boughton, Malgorzata E Wilinska, Roman Hovorka","doi":"10.1089/dia.2024.0298","DOIUrl":"10.1089/dia.2024.0298","url":null,"abstract":"<p><p>The usage and safety of the Boost and Ease-off features in the CamAPS FX hybrid closed-loop system were analyzed in a retrospective analysis of real-world data from 7,464 users over a 12-month period. Boost was used more frequently than Ease-off, but for a shorter duration per use. Mean starting glucose was above range for Boost (229 ± 51 mg/dL), and within range for Ease-off (114 ± 29 mg/dL). Time spent below 70 mg/dL was low during Boost periods [median (interquartile range; IQR) 0.0% (0.0, 0.5%)], and lower than during no Boost periods [2.1% (1.2, 3.4%)], while time spent above 180 mg/dL was lower during Ease-off periods (15 ± 14%) compared with no Ease-off periods (25 ± 12%). There were no episodes of severe hypoglycemia or diabetic ketoacidosis attributed to Boost or Ease-off use. Boost and Ease-off allow users to engage safely with CamAPS FX to manage their glucose levels during periods of more-than-usual and less-than-usual insulin needs.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"60-65"},"PeriodicalIF":5.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141987648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Josip Zivkovic, Michael Mitter, Delphine Theodorou, Johanna Kober, Wiebke Mueller-Hoffmann, Heather Mikulski
{"title":"Transitioning from Self-Monitoring of Blood Glucose to Continuous Glucose Monitoring in Combination with a mHealth App Improves Glycemic Control in People with Type 1 and Type 2 Diabetes.","authors":"Josip Zivkovic, Michael Mitter, Delphine Theodorou, Johanna Kober, Wiebke Mueller-Hoffmann, Heather Mikulski","doi":"10.1089/dia.2024.0169","DOIUrl":"10.1089/dia.2024.0169","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> Integrating mobile health (mHealth) apps into daily diabetes management allows users to monitor and track their health data, creating a comprehensive system for managing daily diabetes activities and generating valuable real-world data. This analysis investigates the impact of transitioning from traditional self-monitoring of blood glucose (SMBG) to real-time continuous glucose monitoring (rtCGM), alongside the use of a mHealth app, on users' glycemic control. <b><i>Methods:</i></b> Data were collected from 1271 diabetes type 1 and type 2 users of the mySugr<sup>®</sup> app who made a minimum of 50 SMBG logs 1 month before transitioning to rtCGM and then used rtCGM for at least 6 months. The mean and coefficient of variation of glucose, along with the proportions of glycemic measurements in and out of range, were compared between baseline and 1, 2, 3, and 6 months of rtCGM use. A mixed-effects linear regression model was built to quantify the specific effects of transitioning to a rtCGM sensor in different subsamples. A novel validation analysis ensured that the aggregated metrics from SMBG and rtCGM were comparable. <b><i>Results:</i></b> Transitioning to a rtCGM sensor significantly improved glycemic control in the entire cohort, particularly among new users of the mySugr app. Additionally, the sustainability of the change in glucose in the entire cohort was confirmed throughout the observation period. People with type 1 and type 2 diabetes exhibited distinct variations, with type 1 experiencing a greater reduction in glycemic variance, while type 2 displayed a relatively larger decrease in monthly averages.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"10-18"},"PeriodicalIF":5.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Janet K Snell-Bergeon, Gurleen Kaur, Drew Renner, Halis K Akturk, Christie Beatson, Satish K Garg
{"title":"Effectiveness of Semaglutide and Tirzepatide in Overweight and Obese Adults with Type 1 Diabetes.","authors":"Janet K Snell-Bergeon, Gurleen Kaur, Drew Renner, Halis K Akturk, Christie Beatson, Satish K Garg","doi":"10.1089/dia.2024.0328","DOIUrl":"10.1089/dia.2024.0328","url":null,"abstract":"<p><p><b><i>Objective:</i></b> Adults with type 1 diabetes (T1D) are increasingly overweight or obese, in part due to intensive insulin therapy. Newer non-insulin medications targeting both hyperglycemia and weight loss are approved for people with type 2 diabetes. These drugs also reduce cardiovascular disease, the major cause of mortality in people with diabetes. We assessed the real-world use of semaglutide and tirzepatide, in adults with T1D followed in a specialty diabetes clinic. <b><i>Materials and Methods:</i></b> This retrospective chart review included 100 adults who were prescribed semaglutide or tirzepatide (50 each) and 50 controls frequency matched for age, sex, diabetes duration, body mass index, and glycosylated hemoglobin (HbA1c) and who did not receive any weight loss medications during the study period. Data were collected prior to initiation of weight loss medications (baseline) and then for up to 1 year for each patient. <b><i>Results:</i></b> Matching characteristics did not differ between cases and controls. There were declines in weight in both semaglutide (-19.2 ± standard error (SE) 2.9 lbs. [9.1% body weight lost]) and tirzepatide (-49.4 ± SE 3.0 lbs. [21.4% body weight lost]) groups, and HbA1c decreased in both semaglutide (-0.54 ± SE 0.14%, <i>P</i> = 0.0001) and tirzepatide users (-0.68 ± SE 0.16%, <i>P</i> < 0.0001) over 12 months. Weight and HbA1c didn't change in controls. <b><i>Conclusions:</i></b> We observed weight loss of 9.1% and 21.4% and improved glucose control in semaglutide and tirzepatide users, respectively, after 1 year of off-label use. As off-label use of these drugs is increasing in patients with T1D, larger, prospective safety and efficacy trials are needed.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"1-9"},"PeriodicalIF":5.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142914004","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Katrine Grønbæk Tidemand, Christian Laugesen, Ajenthen Gayathri Ranjan, Liv Boelskifte Skovhus, Kirsten Nørgaard
{"title":"Frequency of Rebound Hyperglycemia in Adults with Type 1 Diabetes Treated with Different Insulin Delivery Modalities.","authors":"Katrine Grønbæk Tidemand, Christian Laugesen, Ajenthen Gayathri Ranjan, Liv Boelskifte Skovhus, Kirsten Nørgaard","doi":"10.1089/dia.2024.0134","DOIUrl":"10.1089/dia.2024.0134","url":null,"abstract":"<p><p><b><i>Background:</i></b> For people with type 1 diabetes (T1D), ensuring fast and effective recovery from hypoglycemia while avoiding posthypoglycemic hyperglycemia (rebound hyperglycemia, RH) can be challenging. The objective of this study was to investigate the frequency of RH across different treatment modalities and its impact on glycemic control. <b><i>Methods:</i></b> This cross-sectional real-world study included adults with T1D using continuous glucose monitoring and attending the outpatient clinic at Steno Diabetes Center Copenhagen. RH was defined as ≥1 sensor glucose value (SG) >10.0 mmol/L (180 mg/dL) starting within 2 h of an antecedent SG <3.9 mmol/L (70 mg/dL). The severity of the RH events was calculated as area under the curve (AUC) and separately for users of multiple daily injections (MDIs), unintegrated insulin pumps, sensor augmented pumps (SAPs), and automated insulin delivery (AID), respectively. <b><i>Results:</i></b> Across the four groups, SAP and AID users had the highest incidence of RH (2.06 ± 1.65 and 2.08 ± 1.49 events per week, respectively) and a similar percentage of hypoglycemic events leading to RH events (41.3 ± 22.8% and 39.6 ± 20.1%, respectively). The AID users with RH events were significantly shorter compared with MDI users (122 ± 72 vs. 185 ± 135 min; <i>P</i> < 0.0001). Overall, severity of RH was inversely associated with more advanced technology (<i>P</i> < 0.001) and inversely associated (<i>P</i> < 0.001) with time in target range (TIR). <b><i>Conclusions:</i></b> Groups with insulin suspension features experienced the highest frequency of RH; however, AID users tended to experience shorter and less severe RH events. The association between the severity of RH events and TIR suggests that RH should be assessed and used in the guidance of hypoglycemia management.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"60-65"},"PeriodicalIF":5.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141757741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nancy Elbarbary, Abdullah Alguwaihes, Hawazen Zarif, Mohamed Hassanein, Asma Deeb, Goran Petrovski, Raed Al Dahash, Reem Alamoudi, Sufyan Hussain, Mahmoud Ibrahim, Shehla Shaikh, Sueziani Binte Zainudin, Wael Chaar, Tim van den Heuvel, Mohammed E Al-Sofiani
{"title":"MiniMed 780G System Use in Type 1 Diabetes During Ramadan Intermittent Fasting: A Systematic Literature Review and Expert Recommendations.","authors":"Nancy Elbarbary, Abdullah Alguwaihes, Hawazen Zarif, Mohamed Hassanein, Asma Deeb, Goran Petrovski, Raed Al Dahash, Reem Alamoudi, Sufyan Hussain, Mahmoud Ibrahim, Shehla Shaikh, Sueziani Binte Zainudin, Wael Chaar, Tim van den Heuvel, Mohammed E Al-Sofiani","doi":"10.1089/dia.2024.0200","DOIUrl":"10.1089/dia.2024.0200","url":null,"abstract":"<p><p>This article offers a systematic literature review (SLR) on the use of the MiniMed 780G automated insulin delivery system (MM780G) in people with type 1 diabetes (PwT1D) during Ramadan intermittent fasting. It also presents consensus recommendations on the use of MM780G during the Ramadan period. The SLR was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses methodology. The recommendations resulted from a consensus-forming process involving a panel of experts. The process considered evidence found in the SLR as well as the expert opinions. In total, six studies were included in the SLR. The evidence and expert opinions led to recommendations related to (a) pre-Ramadan counseling of MM780G users who plan to fast; (b) suggested MM780G settings, meal announcement strategy, and safety aspects during Ramadan (including a contingency plan); and (c) post-Ramadan transition into and out of Eid-al-Fitr festivities. The SLR findings showed that the MM780G maintains glycemic control at target in PwT1D during Ramadan (meeting continuous glucose monitoring-based clinical targets proposed by the International Consensus on Time-in-Range) while ensuring low rates of hypoglycemia and diabetic ketoacidosis. Automated insulin delivery also helps PwT1D fast more days of Ramadan compared with users of other less advanced modalities of treatment. Pre-Ramadan guidance on specific aspects of the MM780G along with the International Diabetes Federation and Diabetes and Ramadan International Alliance counseling guidelines is recommended. There is still a challenge with post-Iftar hyperglycemia, which could potentially be mitigated by following the recommendations outlined in this article.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"72-85"},"PeriodicalIF":5.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141757742","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Elena Toschi, Stephanie Edwards, Christi Y Kao, Jie Xue, Astrid Atakov-Castillo, Wenjie Wang, Garry Steil, Howard Wolpert
{"title":"What Really Matters?: How Insulin Dose, Timing, and Distribution Relate to Meal Composition in Free-Living People with Type 1 Diabetes.","authors":"Elena Toschi, Stephanie Edwards, Christi Y Kao, Jie Xue, Astrid Atakov-Castillo, Wenjie Wang, Garry Steil, Howard Wolpert","doi":"10.1089/dia.2024.0132","DOIUrl":"10.1089/dia.2024.0132","url":null,"abstract":"<p><p>Optimizing postprandial glucose control in persons with type 1 diabetes (T1D) is challenging. We hypothesized that in free-living individuals, meal composition (high and low glycemic index [HGI and LGI], high and low fat [HF and LF]) may impact insulin requirements. Adults (<i>N</i> = 25) with T1D using open-loop insulin and continuous glucose monitoring were provided a meal-tagging app and prepackaged meals with defined macronutrient content. Data from 463 meals were analyzed. LGI meals required significantly more insulin than HGI meals (<i>P</i> = 0.01). Furthermore, the mean (±standard deviation) carbohydrate-to-insulin ratio (CIR) was significantly different overall among the LGI-LF (5.5 ± 3.4), LGI-HF (4.5 ± 3.8), HGI-LF (7.6 ± 5.1), and HGI-HF (8.7 ± 5.8) meals (<i>P</i> = 0.001). The risk of nocturnal hypoglycemia is associated with daytime hypoglycemia and amount of insulin administered prior to the evening and exercise. This exploratory study designed to examine the impact of different meal types on insulin dosing requirements in free-living adults with T1D emphasizes the need for individualized adjustment of the CIR depending on meal composition.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"66-71"},"PeriodicalIF":5.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141792150","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Comment on Rilstone et al: A Randomized Controlled Trial Assessing the Impact of Continuous Glucose Monitoring with a Predictive Hypoglycemia Alert Function on Hypoglycemia in Physical Activity for People with Type 1 Diabetes (PACE).","authors":"Alexander Seibold","doi":"10.1089/dia.2024.0344","DOIUrl":"10.1089/dia.2024.0344","url":null,"abstract":"","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"e88-e89"},"PeriodicalIF":5.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281837","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Huda Kufaishi, Davide Bertoli, Ditte Smed Kornum, Ajenthen Gayathri Ranjan, Kirsten Nørgaard, Klaus Krogh, Birgitte Brock, Tina Okdahl, Jens Brøndum Frøkjær, Asbjørn Mohr Drewes, Christina Brock, Filip Krag Knop, Tine Willum Hansen, Christian Stevns Hansen, Peter Rossing
{"title":"Possible Glycemic Effects of Vagus Nerve Stimulation Evaluated by Continuous Glucose Monitoring in People with Diabetes and Autonomic Neuropathy: A Randomized, Sham-Controlled Trial.","authors":"Huda Kufaishi, Davide Bertoli, Ditte Smed Kornum, Ajenthen Gayathri Ranjan, Kirsten Nørgaard, Klaus Krogh, Birgitte Brock, Tina Okdahl, Jens Brøndum Frøkjær, Asbjørn Mohr Drewes, Christina Brock, Filip Krag Knop, Tine Willum Hansen, Christian Stevns Hansen, Peter Rossing","doi":"10.1089/dia.2024.0175","DOIUrl":"10.1089/dia.2024.0175","url":null,"abstract":"<p><p><b><i>Objective:</i></b> Autonomic neuropathy is associated with dysglycemia that is difficult to control. We investigated if transcutaneous vagus nerve stimulation (tVNS) could improve glycemic levels. <b><i>Methods:</i></b> We randomized 145 individuals with type 1 diabetes (T1D) (<i>n</i> = 70) or type 2 diabetes (T2D) (<i>n</i> = 75) and diabetic autonomic neuropathy (DAN) to self-administered treatment with active cervical tVNS (<i>n</i> = 68) or sham (<i>n</i> = 77) for 1 week (4 daily stimulations) and 8 weeks (2 daily stimulations), separated by a wash-out period of at least 2 weeks. Continuous glucose monitoring (CGM) indices were measured for 104 participants starting 5 days prior to intervention periods, during the 1-week period, and at end of the 8-week period. Primary outcomes were between-group differences in changes in coefficient of variation (CV) and in time in range (TIR 3.9-10 mmol/L). Secondary outcomes were other metrics of CGM and HbA1c. <b><i>Results:</i></b> For the 1-week period, median [interquartile range] changes of CV from baseline to follow-up were -1.1 [-4.3;2.0] % in active and -1.5 [-4.4;2.5] % in sham, with no significance between groups (<i>P</i> = 0.54). For TIR, the corresponding changes were 2.4 [-2.1;7.4] % in active and 5.1 [-2.6;8.8] in sham group (<i>P</i> = 0.84). For the 8-week treatment period, changes in CV and TIR between groups were also nonsignificant. However, in the subgroup analysis, persons with T1D receiving active tVNS for 8 weeks had a significant reduction in CV compared with the T1D group receiving sham stimulation (estimated treatment effect: -11.6 [95% confidence interval -20.2;-2.0] %, <i>P</i> = 0.009). None of the changes in secondary outcomes between treatment groups were significantly different. <b><i>Conclusions:</i></b> Overall, no significant changes were observed in CGM metrics between treatment arms, while individuals with T1D and DAN decreased their CV after 8 weeks of tVNS treatment.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"52-59"},"PeriodicalIF":5.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}