Glucose Control Using a Standard Versus an Enhanced Hybrid Closed Loop System: A Randomized Crossover Study

Paldus, Barbora; Lee, Melissa H; Jones, Hannah M.; McAuley, Sybil A; Horsburgh, Jodie C.; Roem, Kerryn; Ward, Glenn; MacIsaac, Richard J; Cohen, Neale; Colman, Peter G; Jenkins, Alicia J.; O’Neal, David N

doi:10.1089/dia.2018.0279

Cited by 24 publications

(7 citation statements)

References 2 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This safety profile is similar to that observed in the three-month MiniMed™ 670G system pivotal trials conducted in children, 16 adolescents and adults, 17 as well as the current AHCL system when investigated in the short randomized and controlled studies. 26,28,31,34 Glycemic outcomes of the present study demonstrated reduced A1C and increased overall (24-hour day) TIR in adolescents and adults using the AHCL system, when compared to a run-in period of SAP, PLGM or automated basal insulin delivery use. A further increased TIR (>81%) was observed during the nighttime.…”

Section: Discussionmentioning

confidence: 51%

“…The RCTs capturing participant-reported outcomes also observed improved user satisfaction with the AHCL system, when compared to MiniMed™ 670G HCL system use. 26,28 These improvements in glycemia, time in closed-loop control, and user satisfaction trended similarly with those observed in a different insulin delivery system (Tandem ® Diabetes Care, San Diego, CA) with automated basal and bolus functions. 29 More recently, larger and longer-duration (4-12 weeks per intervention and control) AHCL system RCTs in youth and adults 30,31 , in addition to a brief longitudinal AHCL system evaluation, 32 have reported time in closed loop >90% and demonstrated significantly improved glycemia in endpoints that include overall TIR, TAR and mean SG, while reducing or not changing time spent in hypoglycemia.…”

Section: Introductionmentioning

confidence: 54%

“…There have been several small and short-term randomized controlled trials (RCTs) of the AHCL system in adolescents in a camp setting, 26 adolescents and young adults in a supervised followed by at-home setting, 27 and adults in a supervised live-in setting 28 that demonstrated improved glycemia. Furthermore, these trials highlighted a significant duration of time spent in closed loop (>90%), with each reporting reduced or minimal exits.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes

Carlson

Sherr

Shulman

et al. 2022

Diabetes Technology & Therapeutics

145

View full text Add to dashboard Cite

Introduction: This trial assessed safety and effectiveness of an advanced hybrid closedloop (AHCL) system with automated basal (Auto Basal) and automated bolus correction (Auto Correction) in adolescents and adults with type 1 diabetes (T1D). Materials and Methods:This multi-center, single-arm study involved an intent to treat population of 157 individuals (39 adolescents aged 14-21 years and 118 adults aged ≥22-75 years) with T1D. Study participants used the MiniMed™ AHCL system during a baseline run-in period in which sensor-augmented pump +/-predictive low glucose management or Auto Basal was enabled for ~14 days. Thereafter, Auto Basal and Auto Correction were enabled for a study phase (~90 days), with glucose target set to 100mg/dL or 120mg/dL for ~45 days, followed by the other target for ~45 days. Study endpoints included safety events and change in mean A1C, time in range (TIR, 70-180mg/dL) and time below range (TBR, <70mg/dL). Run-in and study phase values were compared using Wilcoxon signedrank test a or paired t-test.Results: Overall group time spent in closed loop averaged 94.9±5.4% and involved only 1.2±0.8 exits/week. Compared to run-in, AHCL reduced A1C from 7.5±0.8% to 7.0±0.5% (<0.001 a , N=155), TIR increased from 68.8±10.5% to 74.5±6.9% (<0.001 a ) and TBR reduced from 3.3±2.9% to 2.3±1.7% (<0.001 a ). Similar benefits to glycemia were observed for each age group, and were more pronounced for the nighttime (12AM-6AM). The 100mg/dL target increased TIR to 75.4% (N=155), that was further optimized at a lower active insulin time setting (i.e. 2 hours), without increasing TBR. There were no severe hypoglycemia or diabetic ketoacidosis events during the study phase.Conclusions: These findings show that the MiniMed™ AHCL system is safe and allows for achievement of recommended glycemic targets in adolescents and adults with T1D.Adjustments in target and active insulin time settings may further optimize glycemia and improve user experience. a Wilcoxon signed-rank test.

show abstract

Section: Discussionmentioning

confidence: 51%

Section: Introductionmentioning

confidence: 54%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes

Carlson

Sherr

Shulman

et al. 2022

Diabetes Technology & Therapeutics

145

View full text Add to dashboard Cite

show abstract

“…262 Some trials have shown that automatic suspension of insulin delivery significantly reduced the duration and severity of induced hypoglycemia without causing rebound hyperglycemia. 263,264 Q2.11 What is the role of telemedicine in the implementation and ongoing use of diabetes technology?…”

Section: Evidence Basementioning

confidence: 99%

American Association of Clinical Endocrinology Clinical Practice Guideline: The Use of Advanced Technology in the Management of Persons With Diabetes Mellitus

et al. 2021

View full text Add to dashboard Cite

automated insulin dosing continuous glucose monitoring continuous subcutaneous insulin infusion diabetes diabetes technology glucose sensors hybrid closed loop insulin pumps sensor-augmented pump low-glucose suspend predictive low-glucose suspend a b s t r a c t Objective: To provide evidence-based recommendations regarding the use of advanced technology in the management of persons with diabetes mellitus to clinicians, diabetes-care teams, health care professionals, and other stakeholders. Methods: The American Association of Clinical Endocrinology (AACE) conducted literature searches for relevant articles published from 2012 to 2021. A task force of medical experts developed evidence-based guideline recommendations based on a review of clinical evidence, expertise, and informal consensus, according to established AACE protocol for guideline development. Main Outcome Measures: Primary outcomes of interest included hemoglobin A1C, rates and severity of hypoglycemia, time in range, time above range, and time below range. Results: This guideline includes 37 evidence-based clinical practice recommendations for advanced diabetes technology and contains 357 citations that inform the evidence base.Recommendations: Evidence-based recommendations were developed regarding the efficacy and safety of devices for the management of persons with diabetes mellitus, metrics used to aide with the assessment of advanced diabetes technology, and standards for the implementation of this technology. Conclusions: Advanced diabetes technology can assist persons with diabetes to safely and effectively achieve glycemic targets, improve quality of life, add greater convenience, potentially reduce burden of Disclaimer: The American Association of Clinical Endocrinology medical guidelines for clinical practice are systematically developed statements to assist health care professionals in medical decision-making for specific clinical conditions. Most of the content herein is based on clinical evidence. In areas of uncertainty, or when clarification is required, expert opinion and professional judgment were applied.This guideline is a working document that reflects the state of the field at the time of publication. Because rapid changes are expected in this area, periodic revisions are inevitable. We encourage medical professionals to use this information in conjunction with their best clinical judgment. The presented recommendations may not be appropriate in all situations. Any decision by practitioners to apply these guidelines must be made considering local resources and individual patient circumstances.

show abstract

“…Factory calibrated CGM could solve the glitches related to calibration but improvements in AP models are necessary to increase their time of use. For this reason, an enhanced version of 670G, called 780G, obtained the CE mark in June; this new version could dispense automated correction boluses, have different optional glucose targets, and other features to increase the utilization of Auto Mode [115,116].…”

Section: Artificial Pancreasmentioning

confidence: 99%

Current treatment options and challenges in patients with Type 1 diabetes: Pharmacological, technical advances and future perspectives

Boscari

Avogaro

2021

Rev Endocr Metab Disord

View full text Add to dashboard Cite

Type 1 diabetes mellitus imposes a significant burden of complications and mortality, despite important advances in treatment: subjects affected by this disease have also a worse quality of life-related to disease management. To overcome these challenges, different new approaches have been proposed, such as new insulin formulations or innovative devices. The introduction of insulin pumps allows a more physiological insulin administration with a reduction of HbA1c level and hypoglycemic risk. New continuous glucose monitoring systems with better accuracy have allowed, not only better glucose control, but also the improvement of the quality of life. Integration of these devices with control algorithms brought to the creation of the first artificial pancreas, able to independently gain metabolic control without the risk of hypo- and hyperglycemic crisis. This approach has revolutionized the management of diabetes both in terms of quality of life and glucose control. However, complete independence from exogenous insulin will be obtained only by biological approaches that foresee the replacement of functional beta cells obtained from stem cells: this will be a major challenge but the biggest hope for the subjects with type 1 diabetes. In this review, we will outline the current scenario of innovative diabetes management both from a technological and biological point of view, and we will also forecast some cutting-edge approaches to reduce the challenges that hamper the definitive cure of diabetes.

show abstract

Glucose Control Using a Standard Versus an Enhanced Hybrid Closed Loop System: A Randomized Crossover Study

Cited by 24 publications

References 2 publications

Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes

Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes

American Association of Clinical Endocrinology Clinical Practice Guideline: The Use of Advanced Technology in the Management of Persons With Diabetes Mellitus

Current treatment options and challenges in patients with Type 1 diabetes: Pharmacological, technical advances and future perspectives

Contact Info

Product

Resources

About