Diabetes technology & therapeutics最新文献

{"title":"The Cost-Effectiveness of an Advanced Hybrid Closed-Loop System Compared to Standard Management of Type 1 Diabetes in a Singapore Setting.","authors":"Daphne Gardner, Mrinmayee Lakkad, Zhiyu Qiu, Yuta Inoue, Suresh Rama Chandran, Kael Wherry","doi":"10.1089/dia.2023.0455","DOIUrl":"10.1089/dia.2023.0455","url":null,"abstract":"<p><p><b><i>Background:</i></b> Despite advances in technology, glycemic outcomes in people with type 1 diabetes (T1D) remain suboptimal. The MiniMed 780G (MM780G) advanced hybrid closed-loop (AHCL) system is the latest technology for T1D management with established safety and efficacy. This study explores the cost-effectiveness of MM780G AHCL compared against multiple daily injections (MDI) plus intermittently scanned continuous glucose monitor (isCGM). <b><i>Methods:</i></b> A cost-utility analysis was conducted, simulating lifetime outcomes for 1000 T1D individuals, with baseline hemoglobin A1c of 8.4%, using the IQVIA Core Diabetes Model (CDM) v9.5. A Singapore health care payer perspective was taken with 2023 costs applied. Treatment effects were taken from the ADAPT study and treatment-related events from a combination of sources. T1D complication costs were derived from local literature, and health state utilities and disutilities from published literature. Scenario analyses and probabilistic sensitivity analyses (PSAs) explored uncertainty. Cost-effectiveness was assessed based on willingness-to-pay (WTP) thresholds set to Singapore Dollars (SGD) 45,000 (United States Dollars [USD] 33,087) per quality-adjusted life year (QALY) and Singapore's gross domestic product (GDP) per capita of SGD 114,165 (USD 83,941) per QALY. <b><i>Results:</i></b> A switch from MDI plus isCGM to MM780G resulted in expected gains in life-years (+0.78) and QALYs (+1.45). Cost savings through reduction in T1D complications (SGD 25,465; USD 18,723) partially offset the higher treatment costs in the AHCL arm (+SGD 74,538; +USD 54,805), resulting in an estimated incremental cost-effectiveness ratio of SGD 33,797 (USD 24,850) per QALY gained. Findings were robust, with PSA outputs indicating 81% and 99% probabilities of cost-effectiveness at the stated WTP thresholds. <b><i>Conclusion:</i></b> MM780G is a cost-effective option for people with T1D managed in a Singapore setting.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.4,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11058413/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139431880","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Outcomes with MiniMed^TM 780G Advanced Hybrid Closed-Loop Therapy in 2- to 6-Year-Old Children with Type 1 Diabetes.","authors":"Mary B Abraham, Grant J Smith, Julie Dart, Elizabeth A Davis, Timothy W Jones","doi":"10.1089/dia.2023.0508","DOIUrl":"10.1089/dia.2023.0508","url":null,"abstract":"<p><p>Advanced hybrid closed-loop (AHCL) therapy with the Medtronic MiniMed™ 780G system improves glycemia; however, the clinical outcomes in younger children remain less established. This pilot study aimed to explore the continuous glucose monitoring (CGM) metrics in very young children on AHCL. Children between 2 and 7 years of age and on insulin pump therapy were recruited. A 2-week phase in manual mode was followed by a 6-week AHCL phase. CGM metrics were analyzed to review glycemic outcomes. Out of 11 participants enrolled [mean (standard deviation [SD]) age 5.3 (0.8) years], 10 completed the study. Time in closed loop was 96.7 (3.9)%. In AHCL, participants had a mean (SD) time in range of 72.6 (7.4)% and spent 3.0 (1.74)% and 0.63 (0.46)% in time <70 and <54 mg/dL, respectively. AHCL is a feasible option for management of young children with type 1 diabetes.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.4,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139431943","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":"Prevalence, Safety, and Metabolic Control Among Danish Children and Adolescents with Type 1 Diabetes Using Open-Source Automated Insulin Delivery Systems.","authors":"Amanda R Fagerberg, Luise Borch, Kurt Kristensen, Jesper S Hjelle","doi":"10.1089/dia.2023.0412","DOIUrl":"10.1089/dia.2023.0412","url":null,"abstract":"<p><p><b><i>Background:</i></b> Treatment of type 1 diabetes mellitus (T1DM) has become increasingly technical with rapid developments in integration of pumps and sensors to regulate insulin dosage, and patient-initiated solutions as open-source automated insulin delivery (OS-AID) systems, have gained popularity in people with diabetes. Studies have shown increased glycemic control and mental wellbeing in users of OS-AID systems. The aim of this study was to estimate the prevalence, the effect on metabolic control, the risk, and the effect on everyday life for users and their parents of OS-AID systems in Danish children and adolescents with T1DM. <b><i>Methods:</i></b> This retrospective cohort study recruited participants through pediatric diabetes outpatient clinics and social media. Surveys were distributed and current and retrospective data on glycemic control (HbA1c, time in range [TIR] etc.) were collected. <b><i>Results:</i></b> Fifty-six users of OS-AID systems out of 2950 Danish children and adolescents with T1DM were identified from all outpatient clinics in Denmark. Thirty-one responded on contact and were included (55% of the identified), median age 12 [interquartile range: 11-14] years, 51% females, and mean duration of use of OS-AID systems 2.37 ± 0.86 years. Glycemic control increased significantly with TIR increasing from mean 62.29% ± 13.68% to 70.12% ± 10.08%, *<i>P</i> < 0.01, and HbA1c decreasing from mean 50.13 ± 5.76 mmol/mol (6.7% ± 2.7%) to 47.86 ± 6.24 mmol/mol (6.5% ± 2.7%), **<i>P</i> < 0.05. No changes were found in safety parameters. Parents reported better quality of sleep evaluated by Pittsburgh Sleep Quality Index. <b><i>Conclusion:</i></b> This study is the first to provide knowledge on pediatric users of OS-AID systems in Denmark and found a prevalence of 1.89% for OS-AID systems, improved TIR, and no increased risk associated with use of OS-AID systems.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.4,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11058411/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139930413","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Performance of the Dexcom G7 Continuous Glucose Monitoring System in Pregnant Women with Diabetes.","authors":"Sarit Polsky, Amy M Valent, Elvira Isganaitis, Kristin Castorino, Grenye O'Malley, Stayce E Beck, Peggy Gao, Lori M Laffel, Florence M Brown, Carol J Levy","doi":"10.1089/dia.2023.0516","DOIUrl":"10.1089/dia.2023.0516","url":null,"abstract":"<p><p><b><i>Background:</i></b> We evaluated accuracy and safety of a seventh-generation real-time continuous glucose monitoring (CGM) system during pregnancy. <b><i>Materials and Methods:</i></b> Evaluable data for accuracy analysis were obtained from 96 G7 sensors (Dexcom, Inc.) worn by 96 of 105 enrolled pregnant women with type 1 (<i>n</i> = 59), type 2 (<i>n</i> = 21), or gestational diabetes (<i>n</i> = 25). CGM values were compared with arterialized venous glucose values from the YSI comparator instrument during 6-h clinic sessions at different time points throughout the sensors' 10-day wear period. The primary endpoint was the proportion of CGM values in the 70-180 mg/dL range within 15% of comparator glucose values. Secondary endpoints included the proportion of CGM values within 20% or 20 mg/dL of comparator values ≥ or <100 mg/dL, respectively (the %20/20 agreement rate). <b><i>Results:</i></b> Of the 1739 pairs with CGM in the 70-180 mg/dL range, 83.2% were within 15% of comparator values. The lower bound of the 95% confidence interval was 79.8%. Of the 2102 pairs with CGM values in the 40-400 mg/dL range, the %20/20 agreement rate was 92.5%. Of the 1659 pairs with comparator values in the 63-140 mg/dL range, the %20/20 agreement rate was 92.3%. The %20/20 agreement rates on days 1, 4 and 7, and 10 were 78.6%, 96.3%, and 97.3%, respectively. Consensus error grid analysis showed 99.8% of pairs in the clinically acceptable A and B zones. There were no serious adverse events. The sensors' 10-day survival rate was 90.3%. <b><i>Conclusion:</i></b> The G7 system is accurate and safe during pregnancies complicated by diabetes and does not require confirmatory fingerstick testing. <b><i>Clinical Trial Registration:</i></b> clinicaltrials.gov NCT04905628.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11058415/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139691385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Driving-Related Glucose Patterns Among Older Adults with Type 1 Diabetes.","authors":"Hye Jin Kwon, Steven Trawley, Sara Vogrin, Andisheh Mohammad Alipoor, Peter G Colman, Spiros Fourlanos, Charlotte A Grills, Melissa H Lee, Richard J MacIsaac, David N O'Neal, Niamh A O'Regan, Vijaya Sundararajan, Glenn M Ward, Sybil A McAuley","doi":"10.1089/dia.2023.0416","DOIUrl":"10.1089/dia.2023.0416","url":null,"abstract":"<p><p>Older adults with type 1 diabetes may face challenges driving safely. Glucose \"above-5-to-drive\" is often recommended for insulin-treated diabetes to minimize hypoglycemia while driving. However, the effectiveness of this recommendation among older adults has not been evaluated. Older drivers with type 1 diabetes were assessed while using sensor-augmented insulin pumps during a 2-week clinical trial run-in. Twenty-three drivers (median age 69 years [interquartile range; IQR 65-72]; diabetes duration 37 years [20-45]) undertook 618 trips (duration 10 min [5-21]). Most trips (<i>n</i> = 535; 87%) were <30 min duration; 9 trips (1.5%) exceeded 90 min and 3 trips (0.5%) exceeded 120 min. Pre-trip continuous glucose monitoring (CGM) was >5.0 mmol/L for 577 trips (93%) and none of these had CGM <3.9 mmol/L during driving (including 8 trips >90 min and 3 trips >120 min). During 41 trips with pre-trip CGM ≤5.0 mmol/L, 11 trips had CGM <3.9 mmol/L. Seventy-one CGM alerts occurred during 60 trips (10%), of which 54 of 71 alerts (76%) were unrelated to hypoglycemia. Our findings support a glucose \"above-5-to-drive\" recommendation to avoid CGM-detected hypoglycemia among older drivers, including for prolonged drives, and highlight the importance of active CGM low-glucose alerts to prevent hypoglycemia during driving. Driving-related CGM usability and alert functionality warrant investigation. Clinical trial ACTRN1261900515190.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.4,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139691383","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":"Continuous Glucose Monitor Metrics Are Associated with Emergency Department Visits and Hospitalizations for Hypoglycemia and Hyperglycemia, but Have Low Predictive Value.","authors":"Lisa K Gilliam, Melissa M Parker, Howard H Moffet, Alexandra K Lee, Andrew J Karter","doi":"10.1089/dia.2023.0493","DOIUrl":"10.1089/dia.2023.0493","url":null,"abstract":"<p><p><b><i>Objective:</i></b> Determine whether continuous glucose monitor (CGM) metrics can provide actionable advance warning of an emergency department (ED) visit or hospitalization for hypoglycemic or hyperglycemic (dysglycemic) events. <b><i>Research Design and Methods:</i></b> Two nested case-control studies were conducted among insulin-treated diabetes patients at Kaiser Permanente, who shared their CGM data with their providers. Cases included dysglycemic events identified from ED and hospital records (2016-2021). Controls were selected using incidence density sampling. Multiple CGM metrics were calculated among patients using CGM >70% of the time, using CGM data from two lookback periods (0-7 and 8-14 days) before each event. Generalized estimating equations were specified to estimate odds ratios and C-statistics. <b><i>Results:</i></b> Among 3626 CGM users, 108 patients had 154 hypoglycemic events and 165 patients had 335 hyperglycemic events. Approximately 25% of patients had no CGM data during either lookback; these patients had >2 × the odds of a hypoglycemic event and 3-4 × the odds of a hyperglycemic event. While several metrics were strongly associated with a dysglycemic event, none had good discrimination. <b><i>Conclusion:</i></b> Several CGM metrics were strongly associated with risk of dysglycemic events, and these can be used to identify higher risk patients. Also, patients who are not using their CGM device may be at elevated risk of adverse outcomes. However, no CGM metric or absence of CGM data had adequate discrimination to reliably provide actionable advance warning of an event and thus justify a rapid intervention.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11058412/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139562935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Relationship Between Glycated Hemoglobin and Time in Range in a Pediatric Population.","authors":"Mathilde Vandenbempt, Hanne Matheussen, Sara Charleer, Anne Rochtus, Kristina Casteels","doi":"10.1089/dia.2023.0482","DOIUrl":"10.1089/dia.2023.0482","url":null,"abstract":"<p><p>In adults with type 1 diabetes (T1D), time in range (TIR) [70-180 mg/dL] has been proposed as an additional metric besides glycated hemoglobin (HbA1c). This retrospective monocentric cohort study determined the correlation between HbA1c and TIR during the 2, 4, and 12 weeks (TIR_2w, TIR_4w, and TIR_12w) before consultation in a pediatric T1D population. A total of 168 children with T1D were included. Continuous glucose monitoring data, HbA1c, and demographic variables were collected. We found strong linear correlations between HbA1c and TIR_2w (<i>R</i> = -0.571), HbA1c and TIR_4w (<i>R</i> = -0.603), and between HbA1c and TIR_12w (<i>R</i> = -0.624). A strong correlation exists between TIR_2w and TIR_12w, HbA1c and time above range (TAR), and between TIR and TAR at different time points. In conclusion, a strong correlation was found between HbA1c and TIR, making TIR a potentially complementary metric to HbA1c. TIR_2w seems a viable alternative to TIR_12w. TAR also seems promising in assessing glycemic control.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.4,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138828698","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":"Validation of the UVA Simulation Replay Methodology Using Clinical Data: Reproducing A Randomized Clinical Trial.","authors":"María F Villa-Tamayo, Patricio Colmegna, Marc D Breton","doi":"10.1089/dia.2023.0595","DOIUrl":"https://doi.org/10.1089/dia.2023.0595","url":null,"abstract":"BACKGROUND\u0000Computer simulators of human metabolism are powerful tools to design and validate new diabetes treatments. However, these platforms are often limited in the diversity of behaviors and glycemic conditions they can reproduce. Replay methodologies leverage field-collected data to create ad-hoc simulation environments representative of real-life conditions. After formal validations of our method in prior publications, we demonstrate its capacity to reproduce a recent clinical trial.\u0000\u0000\u0000METHODS\u0000Using the replay methodology, an ensemble of replay simulators was generated using data from a randomized crossover clinical trial comparing hybrid closed loop (HCL) and fully closed loop (FCL) control modalities in automated insulin delivery (AID), creating 64 subject/modality pairs. Each virtual subject was exposed to the alternate AID modality to compare the simulated vs observed glycemic outcomes. Equivalence tests were performed for time in, below, and above range (TIR, TBR, TAR) and glucose indexes (LBGI, HBGI) considering equivalence margins corresponding to clinical significance.\u0000\u0000\u0000RESULTS\u0000TIR, TAR, LBGI, and HBGI showed statistical and clinical equivalence between the original and the simulated data, TBR failed the equivalence test. For example, in HCL mode, simulated TIR was 84.89% vs. an observed 84.31% (p=0.0170, CI [-3.96,2.79]), and for FCL mode, TIR was 76.58% versus 77.41% (p=0.0222, CI [-2.54,4.20]).\u0000\u0000\u0000CONCLUSION\u0000Clinical trial data confirms the prior in-silico validation of the UVA replay method in predicting the glycemic impact of modified insulin treatments. This in-vivo demonstration justifies the application of the replay method to the personalization and adaptation of treatment strategies in people with T1D.","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.4,"publicationDate":"2024-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140653757","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":"Mitigating Severe Hypoglycemia in Users of Advanced Diabetes Technologies: Impaired Awareness of Hypoglycemia and Unhelpful Hypoglycemia Beliefs as Targets for Interventions.","authors":"Yu Kuei Lin, Wen Ye, Helen Rogers, A. Brooks, Elena Toschi, D. Kariyawasam, Simon R Heller, N. de Zoysa, Stephanie A Amiel","doi":"10.1089/dia.2024.0039","DOIUrl":"https://doi.org/10.1089/dia.2024.0039","url":null,"abstract":"OBJECTIVE\u0000A subgroup analysis of the Hypoglycemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycemia (HARPdoc) trial was conducted to explore the impact of Blood Glucose Awareness Training (BGAT, a hypoglycemia awareness training program) and the HARPdoc (a psychoeducation addressing unhelpful hypoglycemia beliefs) in reducing severe hypoglycemia (SH) in individuals using advanced diabetes technologies (ADTs).\u0000\u0000\u0000METHODS\u0000Data from trial participants who utilized ADTs including continuous glucose monitors or automated insulin delivery systems were extracted. Generalized linear mixed effects models with Poisson distribution or linear mixed effects models were employed to evaluate SH incidence, and Gold questionnaire, Attitudes to Awareness of Hypoglycemia (A2A), Problem Areas in Diabetes (PAID), Hospital Anxiety and Depress Scale (HADS)-anxiety, and HADS-depression scores as measures of hypoglycemia awareness, unhelpful hypoglycemia beliefs, diabetes distress, and anxiety and depression symptoms, respectively.\u0000\u0000\u0000RESULTS\u0000In the 45 participants using ADTs, the BGAT and HARPdoc interventions both reduced SH incidence by more than 50% (P<0.0001) and yielded improvements in hypoglycemia awareness (P<0.05). HARPdoc outperformed BGAT in reducing SH at month 24 (P=0.01). HARPdoc also mitigated unhelpful hypoglycemia beliefs (P<0.0001), diabetes distress (P<0.05), and anxiety symptoms (P<0.05); BGAT demonstrated no significant impacts in these respects. Neither HARPdoc nor BGAT had significant effects on depression symptoms.\u0000\u0000\u0000CONCLUSION\u0000Psychoeducation (BGAT and HARPdoc) was effective in reducing SH in people using ADTs. HARPdoc may also provide greater long-term SH reduction and improves psychological wellbeing in this patient group.","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.4,"publicationDate":"2024-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140654395","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":"Adaptive bio-behavioral control: A pilot analysis of human-machine co-adaptation in type 1 diabetes.","authors":"Patricio Colmegna, Ryan Mcfadden, Chiara Fabris, Benjamin J. Lobo, Ralf Nass, Mary Clancy-Oliveri, Sue A Brown, B. Kovatchev","doi":"10.1089/dia.2023.0399","DOIUrl":"https://doi.org/10.1089/dia.2023.0399","url":null,"abstract":"BACKGROUND\u0000While it is well recognized that an automated insulin delivery (AID) algorithm should adapt to changes in physiology, it is less understood that the individual would also have to adapt to the AID system. The adaptive bio-behavioral control (ABC) method presented here attempts to compensate for this deficiency by including AID into an information cloud-based ecosystem.\u0000\u0000\u0000METHODS\u0000The Web Information Tool (WIT) implements the ABC concept via: (1) A Physiological Adaptation Module (PAM) that tracks metabolic changes and adapts AID parameters accordingly, and (2) a Behavioral Adaptation Module (BAM) that provides information feedback. The safety of WIT (primary outcome) was assessed in an 8-week randomized, two-arm parallel pilot study. All participants used the Control-IQ® AID system enhanced with PAM, but only those in the Experimental group had access to BAM. Secondary glycemic outcomes were computed using the 2-week baseline period and the last 2 weeks of treatment.\u0000\u0000\u0000RESULTS\u0000Thirty participants with type 1 diabetes (T1D) completed all study procedures (17F/13M; age: 40±14y; HbA1c: 6.6%±0.5%). No severe hypoglycemia, DKA, or other serious adverse events were reported. Comparing Experimental and Control groups, no significant difference was observed in time in range (70-180 mg/dL): 74.6% vs 73.8%, adjusted mean difference: 2.65%, 95%¬¬¬¬¬CI (-1.12%,6.41%), P=0.161. Time in 70-140 mg/dL was significantly higher in the Experimental group: 50.7% vs 49.2%, 5.71% (0.44%,10.97%), P=0.035, without increased time below range: 0.54% (-0.09%,1.17%), P=0.089.\u0000\u0000\u0000CONCLUSION\u0000The results demonstrate it is safe to integrate an AID system into the WIT ecosystem. Validation in a full-scale study is ongoing.","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.4,"publicationDate":"2024-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140658386","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}