المؤلفون: Kruger, Davida¹ (NURSE), Kass, Alex² (NURSE), Lonier, Jacqueline³ (AUTHOR), Pettus, Jeremy⁴ (AUTHOR), Raskin, Philip⁵ (AUTHOR), Salam, Maamoun⁶ (AUTHOR), Trikudanathan, Subbulaxmi⁷ (AUTHOR), Zhou, Keren⁸ (AUTHOR), Russell, Steven J.⁹ (AUTHOR), Damiano, Edward R.^10,11 (AUTHOR), El-Khatib, Firas H.¹¹ (AUTHOR), Ruedy, Katrina J.¹² (AUTHOR), Balliro, Courtney⁹ (AUTHOR), Li, Zoey¹² (AUTHOR), Marak, Martin Chase¹² (AUTHOR), Calhoun, Peter¹² (AUTHOR), Beck, Roy W.¹² (AUTHOR) rbeck@jaeb.org

المصدر: Diabetes Technology & Therapeutics. Oct2022, Vol. 24 Issue 10, p697-711. 15p.

مصطلحات موضوعية: *TYPE 1 diabetes, *INSULIN aspart, *CLOSED loop systems, *BIONICS, *PANCREAS

مستخلص: Objective: To evaluate the insulin-only configuration of the iLet® bionic pancreas (BP) using insulin aspart or insulin lispro in adults with type 1 diabetes (T1D). Methods: In this multicenter, randomized, controlled trial, 161 adults with T1D (18-79 years old, baseline HbA1c 5.5%-13.1%, 32% using multiple daily injections, 27% using a pump without automation, 5% using a pump with predictive low glucose suspend, and 36% using a hybrid closed loop system before the study) were randomly assigned 2:1 to use the BP (N = 107) with insulin aspart or insulin lispro (BP group) or a standard-of-care (SC) control group (N = 54) using their usual insulin delivery plus continuous glucose monitoring (CGM). The primary outcome was HbA1c at 13 weeks. Results: Mean HbA1c decreased from 7.6% ± 1.2% at baseline to 7.1% ± 0.6% at 13 weeks with BP versus 7.6% ± 1.2% to 7.5% ± 0.9% with SC (adjusted difference = -0.5%, 95% confidence interval -0.6% to -0.3%, P < 0.001). Over 13 weeks, mean time in range 70-180 mg/dL (TIR) increased by 11% (2.6 h/d) and mean CGM glucose was reduced by 16 mg/dL with BP compared with SC (P < 0.001). Improvement in these metrics was seen during the first day of BP use and by the end of the first week reached levels that remained relatively stable through 13 weeks. Analyses of time >180 mg/dL, time >250 mg/dL, and standard deviation of CGM glucose all favored the BP group (P < 0.001). The CGM-measured hypoglycemia was low at baseline (median time <54 mg/dL of 0.21% [3 min/d] for the BP group and 0.11% [1.6 min/d] for the SC group) and not significantly different between groups over the 13 weeks (P = 0.51 for time <70 mg/dL and 0.33 for time <54 mg/dL). There were 7 (6.5% of 107 participants) severe hypoglycemic events in the BP group and 2 events in the SC group (1.9% of 54 participants, P = 0.40). Conclusions: In adults with T1D, use of the BP with insulin aspart or insulin lispro improved HbA1c, TIR, and hyperglycemic metrics without increasing CGM-measured hypoglycemia compared with standard of care. Clinical Trial Registry: clinicaltrials.gov; NCT04200313. [ABSTRACT FROM AUTHOR]

المؤلفون: Beck, Roy W.¹ (AUTHOR) rbeck@jaeb.org, Russell, Steven J.² (AUTHOR), Damiano, Edward R.^3,4 (AUTHOR), El-Khatib, Firas H.⁴ (AUTHOR), Ruedy, Katrina J.¹ (AUTHOR), Balliro, Courtney² (NURSE), Li, Zoey¹ (AUTHOR), Calhoun, Peter¹ (AUTHOR)

المصدر: Diabetes Technology & Therapeutics. Oct2022, Vol. 24 Issue 10, p681-696. 16p.

مصطلحات موضوعية: *INSULIN aspart, *TYPE 1 diabetes, *BIONICS, *PANCREAS, *INSULIN therapy

مستخلص: Objective: To evaluate the insulin-only configuration of the iLet® bionic pancreas (BP) using fast-acting insulin aspart (Fiasp®) in adults with type 1 diabetes (T1D). Research Design and Methods: In this multicenter, randomized trial, 275 adults with T1D (18–83 years old, baseline HbA1c 5.3%–14.9%) were randomly assigned 2:2:1 to use the BP with fast-acting insulin aspart (BP-F group, N = 114), BP with aspart or lispro (BP-A/L group, N = 107), or a control group using their standard-care insulin delivery (SC group, N = 54) plus real-time continuous glucose monitoring (CGM). The primary outcome was HbA1c at 13 weeks. The BP-F versus SC comparison was considered primary and BP-F versus BP-A/L secondary. Results: Mean ± standard deviation (SD) HbA1c decreased from 7.8% ± 1.2% at baseline to 7.1% ± 0.6% at 13 weeks with BP-F versus 7.6% ± 1.2% to 7.5% ± 0.9% with SC (adjusted difference = −0.5%, 95% CI −0.7 to −0.3, P < 0.001). CGM-measured percent time <54 mg/dL over 13 weeks with BP-F was noninferior to SC (adjusted difference = 0.00%, 95% CI −0.07 to 0.05, P < 0.001 for noninferiority based on a prespecified noninferiority limit of 1%). Over 13 weeks, mean time in range 70–180 mg/dL (TIR) increased by 14% (3.4 h/day) and mean CGM glucose was reduced by 18 mg/dL with BP-F compared with SC (P < 0.001). Analyses of time >180 mg/dL, time >250 mg/dL, and the SD of CGM glucose all favored BP-F compared with SC (P < 0.001). Differences between BP-F and BP-A/L were minimal, with no difference in HbA1c at 13 weeks (adjusted difference = −0.0%, 95% CI −0.2 to 0.1, P = 0.67) or mean glucose (adjusted difference = −2.0 mg/dL, 95% CI −4.3 to 0.4, P = 0.10). Mean TIR was 2% greater with BP-F than BP-A/L (95% CI 1 to 4, P = 0.005), but the percentages of participants improving TIR by ≥5% were not significantly different (P = 0.49) and there were no significant differences comparing BP-F versus BP-A/L across nine patient-reported outcome surveys. The rate of severe hypoglycemia events did not differ among the three groups. Conclusions: In adults with T1D, HbA1c was improved with the BP using fast-acting insulin aspart compared with standard care without increasing CGM-measured hypoglycemia. However, the effect was no better than the reduction observed with the BP using aspart or lispro. Clinical Trial Registry: clinicaltrials.gov; NCT04200313. [ABSTRACT FROM AUTHOR]

المؤلفون: Abdulhussein, Fatema S, Chesser, Hannah, Boscardin, W John, Gitelman, Stephen E, Wong, Jenise C

المصدر: Diabetes technology & therapeutics. 23(10)

مصطلحات موضوعية: Humans, Diabetes Mellitus, Type 1, Glucose, Blood Glucose, Blood Glucose Self-Monitoring, Retrospective Studies, Adolescent, Adult, Child, Child, Preschool, Benchmarking, Young Adult, Pandemics, COVID-19, SARS-CoV-2, Continuous glucose monitoring, Pediatrics, Time in range, Type 1 diabetes, Pediatric, Autoimmune Disease, Diabetes, Metabolic and endocrine, Clinical Sciences, Medical Physiology, Endocrinology & Metabolism

الوصف: Background: The impact of the coronavirus disease-2019 (COVID-19) pandemic on glycemic metrics in children is uncertain. This study evaluates the effect of the shelter-in-place (SIP) mandate on glycemic metrics in youth with type 1 diabetes (T1D) using continuous glucose monitoring (CGM) in Northern California, United States. Methods: CGM and insulin pump metrics in youth 3-21 years old with T1D at an academic pediatric diabetes center were analyzed retrospectively. Data 2-4 months before (distant pre-SIP), 1 month before (immediate pre-SIP), 1 month after (immediate post-SIP), and 2-4 months after (distant post-SIP) the SIP mandate were compared using paired t-tests, linear regression, and longitudinal analysis using a mixed effects model. Results: Participants (n = 85) had reduced mean glucose (-10.3 ± 4.4 mg/dL, P = 0.009), standard deviation (SD) (-5.0 ± 1.3 mg/dL, P = 0.003), glucose management indicator (-0.2% ± 0.03%, P = 0.004), time above range (TAR) >250 mg/dL (-3.5% ± 1.7%, P = 0.01), and increased time in range (TIR) (+4.7% ± 1.7%, P = 0.0025) between the distant pre-SIP and distant post-SIP periods. Relationships were maintained using a mixed effects model, when controlling for other demographic variables. There was improvement in SD, TAR 180-250 mg/dL, and TIR for participants with private insurance, but changes in the opposite direction for participants with public insurance. Conclusions: Improvement in CGM metrics in youth with T1D during the COVID-19 pandemic suggests that diabetes management can be maintained in the face of sudden changes to daily living. Youth with public insurance deserve more attention in research and clinical practice.

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/2v4531qqTest

المؤلفون: Levy, Carol J.¹ (AUTHOR), O'Malley, Grenye¹ (AUTHOR), Raghinaru, Dan² (AUTHOR), Kudva, Yogish C.³ (AUTHOR), Laffel, Lori M.^4,5 (AUTHOR), Pinsker, Jordan E.⁶ (AUTHOR), Lum, John W.² (AUTHOR) jl_manuscripts@jaeb.org, Brown, Sue A.⁷ (AUTHOR), Kovatchev, Boris (AUTHOR), Anderson, Stacey (AUTHOR), Emory, Emma (AUTHOR), Voelmle, Mary (AUTHOR), Conshafter, Katie (AUTHOR), Morris, Kim (AUTHOR), Oliveri, Mary (AUTHOR), Gondor-Fredrick, Linda (AUTHOR), Mitchell, Harry (AUTHOR), Calvo, Kayla (AUTHOR), Wakeman, Christian (AUTHOR), Breton, Marc (AUTHOR)

المصدر: Diabetes Technology & Therapeutics. May2022, Vol. 24 Issue 5, p357-361. 5p.

مصطلحات موضوعية: *MENSTRUAL cycle, *TYPE 1 diabetes, *INSULIN, *GLYCEMIC control, *GLUCOSE, *BLOOD sugar analysis, *INSULIN therapy, *BLOOD sugar monitoring, *HYPOGLYCEMIC agents, *INSULIN pumps, *RESEARCH funding

مستخلص: Objective: To analyze insulin delivery and glycemic metrics throughout the menstrual cycle for women with type 1 diabetes using closed loop control (CLC) insulin delivery. Methods: Menstruating women using a CLC system in a clinical trial were invited to record their menstrual cycles through a cycle-tracking application. Sixteen participants provided data for this secondary analysis over three or more complete cycles. Insulin delivery and continuous glucose monitoring (CGM) data were analyzed in relation to reported cycle phases. Results: Insulin delivery and CGM metrics remained consistent during cycle phases. Intraparticipant variability of CGM metrics and weight-based insulin delivery did not change through cycle phases. Conclusions: For this sample of menstruating women with type 1 diabetes using a CLC system, insulin delivery and glycemic metrics remained stable throughout menstrual cycle phases. Additional studies in this population are needed, particularly among women who report variable glycemic control during their cycles. Trial Registration: NCT03591354. [ABSTRACT FROM AUTHOR]

المؤلفون: Pettus, Jeremy H, Kushner, Jake A, Valentine, Virginia, Wood, Richard, Pang, Christianne, Paranjape, Sachin, Berria, Rachele, Deluzio, Antonio, Edelman, Steven E

المصدر: Diabetes technology & therapeutics. 21(6)

مصطلحات موضوعية: Humans, Diabetes Mellitus, Type 1, Blood Glucose Self-Monitoring, Qualitative Research, Needs Assessment, Adult, Aged, Aged, 80 and over, Middle Aged, Health Services Needs and Demand, Female, Male, Young Adult, Patient Preference, Glycated Hemoglobin A, Patient-reported outcomes, Survey, Treatment, Diabetes Mellitus, Type 1, and over, Endocrinology & Metabolism, Clinical Sciences, Medical Physiology

الوصف: Background: Adjunct therapy can help patients with type 1 diabetes achieve glycemic goals while potentially mitigating some of the side effects of insulin. In this study, we used a patient survey to identify the unmet needs in type 1 diabetes therapy, patient views of treatment benefit-risk trade-offs, and patient preferences for the use of an adjunct therapy. Methods: A quantitative survey was sent to 2084 adults with type 1 diabetes in November 2017. "Jobs-to-be-done" and conjoint analyses were performed on survey responses to identify unmet needs and the importance of treatment-associated benefits and risks to patients. A 5-point Likert scale measured the importance and satisfaction with patients' current therapy, and with gaps relating to unmet needs. In the conjoint analysis, patients were asked to choose between "packages" of attributes of two doses of adjunct therapy (200 and 400 mg) and placebo, based on established benefits and side effects. Results: A total of 1313 patients (63%) responded. The greatest unmet needs identified were simplifying treatment, lowering/maintaining glycated hemoglobin (HbA1c), reducing mental effort, and increasing time in range (TIR). Conjoint analysis showed that reductions in body weight and TIR had the highest attribute importance (25% and 18%, respectively). The majority (93%) of patients had a preference for the adjunct therapy (either dose) over placebo. Conclusions: This survey highlights the importance of measures beyond HbA1c, such as treatment simplification and TIR, and patient preference for adjunct therapies that help address unmet needs in type 1 diabetes treatment.

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/0rj8b885Test

المؤلفون: Wong, Jenise C, Izadi, Zara, Schroeder, Shannon, Nader, Marie, Min, Jennifer, Neinstein, Aaron B, Adi, Saleh

المصدر: Diabetes Technology & Therapeutics. 20(12)

مصطلحات موضوعية: Diabetes, Bioengineering, Clinical Research, Pediatric, Health Services, Metabolic and endocrine, Good Health and Well Being, Adult, Ambulatory Care, Blood Glucose Self-Monitoring, Child, Decision Support Techniques, Diabetes Mellitus, Type 1, Electronic Health Records, Feasibility Studies, Female, Focus Groups, Health Personnel, Humans, Male, Middle Aged, Patient Care Team, Patient Participation, Pediatrics, Pilot Projects, Software, Surveys and Questionnaires, Systems Integration, Young Adult, Type 1 diabetes mellitus, Insulin pumps, Continuous glucose monitoring, Diabetes data, Data integration, Data visualization., Clinical Sciences, Medical Physiology, Endocrinology & Metabolism

الوصف: BackgroundDiabetes devices provide data for health care providers (HCPs) and people with type 1 diabetes to make management decisions. Extracting and viewing the data require separate, proprietary software applications for each device. In this pilot study, we examined the feasibility of using a single software platform (Tidepool) that integrates data from multiple devices.Materials and methodsParticipating HCPs (n = 15) used the software with compatible devices in all patient visits for 6 months. Samples of registration desk activity and office visits were observed before and after introducing the software, and HCPs provided feedback by survey and focus groups.ResultsThe time required to upload data and the length of the office visit did not change. However, the number of times the HCP referred to the device data with patients increased from a mean of 2.8 (±1.2) to 6.1 (±3.1) times per visit (P = 0.0002). A significantly larger proportion of children looked at the device data with the new application (baseline: 61% vs. study end: 94%, P = 0.015). HCPs liked the web-based user interface, integration of the data from multiple devices, the ability to remotely access data, and use of the application to initiate patient education. Challenges included the need for automated data upload and integration with electronic medical records.ConclusionsThe software did not add to the time needed to upload data or the length of clinic visits and promoted discussions with patients about data. Future studies of HCP use of the application will evaluate clinical outcomes and effects on patient engagement and self-management.

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/1fp8m9rtTest

المؤلفون: Danne, Thomas, Pettus, Jeremy, Giaccari, Andrea, Cariou, Bertrand, Rodbard, Helena, Weinzimer, Stuart A, Bonnemaire, Mireille, Sawhney, Sangeeta, Stewart, John, Wang, Stella, de Cassia Castro, Rita, Garg, Satish K

المصدر: Diabetes Technology & Therapeutics. 21(9)

مصطلحات موضوعية: Clinical Trials and Supportive Activities, Autoimmune Disease, Diabetes, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Metabolic and endocrine, Adult, Blood Glucose, Diabetes Mellitus, Type 1, Double-Blind Method, Drug Therapy, Combination, Female, Glycated Hemoglobin A, Glycosides, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Male, Middle Aged, Sodium-Glucose Transporter 2 Inhibitors, Treatment Outcome, Glycated Hemoglobin, Efficacy beyond HbA1c, HbA1c, SGLT1/SGLT2 inhibitors, Sotagliflozin, inTandem, Clinical Sciences, Medical Physiology, Endocrinology & Metabolism

الوصف: Background: Hypoglycemia rates usually increase when insulin treatment is intensified to improve glycemic control. We evaluated (post hoc) hypoglycemic rates in adult patients with type 1 diabetes (T1D) on sotagliflozin (a dual sodium-glucose cotransporter [SGLT] 1 and 2 inhibitor) in two phase 3, 52-week clinical trials (inTandem 1 and 2; NCT02384941 and NCT02421510). Materials and Methods: We analyzed rates of documented hypoglycemia (level 1, blood glucose ≥54 to

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/809350mdTest

المؤلفون: Wong, Jenise C, Neinstein, Aaron B, Spindler, Matthew, Adi, Saleh

المصدر: Diabetes technology & therapeutics. 17(8)

مصطلحات موضوعية: Humans, Diabetes Mellitus, Type 1, Blood Glucose, Blood Glucose Self-Monitoring, Logistic Models, Odds Ratio, Cross-Sectional Studies, Health Behavior, Age Factors, Information Storage and Retrieval, Adolescent, Adult, Child, Caregivers, Female, Male, Young Adult, Glycated Hemoglobin A, Diabetes Mellitus, Type 1, Hemoglobin A, Glycosylated, Endocrinology & Metabolism, Clinical Sciences, Medical Physiology

الوصف: BackgroundIn type 1 diabetes (T1D), periodic review of blood glucose and insulin dosing should be performed, but it is not known how often patients review these data on their own. We describe the proportion of patients with T1D who routinely downloaded and reviewed their data at home.Materials and methodsA cross-sectional survey of 155 adults and 185 caregivers of children with T1D at a single academic institution was performed. "Routine Downloaders" (downloaded four or more times in the past year) were also considered "Routine Reviewers" if they reviewed their data most of the time they downloaded from devices. Logistic regression was used to identify factors associated with being a Routine Reviewer.ResultsOnly 31% of adults and 56% of caregivers reported ever downloading data from one or more devices, whereas 20% and 40%, respectively, were considered Routine Downloaders. Only 12% of adults and 27% of caregivers were Routine Reviewers. Mean hemoglobin A1c was lower in Routine Reviewers compared with non-Routine Reviewers (7.2±1.0% vs. 8.1±1.6% [P=0.03] in adults and 7.8±1.4% vs. 8.6±1.7% [P=0.001] in children). In adjusted analysis of adults, the odds ratio of being a Routine Reviewer of one or more devices for every 10-year increase in age was 1.5 (95% confidence interval, 1.1, 2.1 [P=0.02]). For every 10 years since diabetes diagnosis, the odds ratio of being a Routine Reviewer was 1.7 (95% confidence interval, 1.2, 2.4 [P=0.01]). For caregivers, there were no statistically significant factors associated with being a Routine Reviewer.ConclusionsA minority of T1D patients routinely downloads and reviews data from their devices on their own. Further research is needed to understand obstacles, provide better education and tools for self-review, and determine if patient self-review is associated with improved glycemic control.

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/80h5d9q8Test

المؤلفون: Harvey, Rebecca A, Dassau, Eyal, Bevier, Wendy C, Seborg, Dale E, Jovanovič, Lois, Doyle, Francis J, Zisser, Howard C

المصدر: Diabetes Technology & Therapeutics. 16(6)

مصطلحات موضوعية: Prevention, Diabetes, Bioengineering, Autoimmune Disease, Patient Safety, Clinical Research, Metabolic and endocrine, Adult, Algorithms, Blood Glucose, Blood Glucose Self-Monitoring, Diabetes Mellitus, Type 1, Female, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Male, Meals, Middle Aged, Monitoring, Physiologic, Pancreas, Artificial, Predictive Value of Tests, Clinical Sciences, Medical Physiology, Endocrinology & Metabolism

الوصف: BackgroundThis study was performed to evaluate the safety and efficacy of a fully automated artificial pancreas using zone-model predictive control (zone-MPC) with the health monitoring system (HMS) during unannounced meals and overnight and exercise periods.Subjects and methodsA fully automated closed-loop artificial pancreas was evaluated in 12 subjects (eight women, four men) with type 1 diabetes (mean±SD age, 49.4±10.4 years; diabetes duration, 32.7±16.0 years; glycosylated hemoglobin, 7.3±1.2%). The zone-MPC controller used an a priori model that was initialized using the subject's total daily insulin. The controller was designed to keep glucose levels between 80 and 140 mg/dL. A hypoglycemia prediction algorithm, a module of the HMS, was used in conjunction with the zone controller to alert the user to consume carbohydrates if the glucose level was predicted to fall below 70 mg/dL in the next 15 min.ResultsThe average time spent in the 70-180 mg/dL range, measured by the YSI glucose and lactate analyzer (Yellow Springs Instruments, Yellow Springs, OH), was 80% for the entire session, 92% overnight from 12 a.m. to 7 a.m., and 69% and 61% for the 5-h period after dinner and breakfast, respectively. The time spent < 60 mg/dL for the entire session by YSI was 0%, with no safety events. The HMS sent appropriate warnings to prevent hypoglycemia via short and multimedia message services, at an average of 3.8 treatments per subject.ConclusionsThe combination of the zone-MPC controller and the HMS hypoglycemia prevention algorithm was able to safely regulate glucose in a tight range with no adverse events despite the challenges of unannounced meals and moderate exercise.

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/5024f7jqTest

المؤلفون: Viral N. Shah, Halis K. Akturk, Tim Vigers, Laura Pyle, Nick Oliver, David C. Klonoff

المصدر: Diabetes Technology & Therapeutics. 25:62-68

مصطلحات موضوعية: Adult, Male, Blood Glucose, Glycated Hemoglobin, Blood Glucose Self-Monitoring, Endocrinology, Diabetes and Metabolism, Middle Aged, Young Adult, Benchmarking, Medical Laboratory Technology, Diabetes Mellitus, Type 1, Endocrinology, Humans, Female

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d45d5976f7f9e5fcd03893083a2313adTest
https://doi.org/10.1089/dia.2022.0365Test