Feasibility Study of a Hybrid Closed-Loop System with Automated Insulin Correction Boluses.

Abstract:

: Background: The Medtronic MiniMed™ 670G system adjusts basal insulin delivery in response to continuous glucose monitoring levels and is already in use in clinical practice. We tested the home-based feasibility of the new MiniMed advanced hybrid closed-loop (AHCL) system, which includes several algorithm enhancements and an optional autocorrection bolus mode. Methods: Twelve adolescents and young adults (eight females) with type 1 diabetes [median (interquartile range)] aged 16.6 (15.9, 18.2) years and diabetes duration of 7.1 (4.7, 8.8) years] participated in this single-arm study. The first stage was a 6-day open-loop run-in period, with the predictive low-glucose suspend feature on. This was followed by 6 days/5 nights in a supervised hotel setting, using the AHCL system, including closed-loop challenges (missed meal bolus, late meal bolus, and physical activity); and finally, 3 weeks with unrestricted home use. Glycemic parameters were compared between the open-loop and closed-loop periods. Results: Participants spent 93.3% (4.7) of the time in SmartGuard™ Auto Mode. Hemoglobin A1C levels decreased from median (interquartile range) 7.1% (6.7, 7.9) at baseline to 6.8% (6.6, 7.4) at study end, after 4 weeks (P = 0.0027). Time in range (TIR) (70-180 mg/dL) was 68.4% (10.6) and time below 70 mg/dL was 4% (3.5) during open-loop; and 74% (6.1) and 2.6% (1.9), respectively, during the closed-loop at home phase (P = 0.06, P = 0.27). TIR increased during the nighttime, from 64.6% (17.4) to 80.7% (7.8), P = 0.007, without change in time below 70 mg/dL (P = 0.15). No serious adverse events occurred. Conclusions: The new AHCL system demonstrated safety and effectiveness in controlling day and night glucose levels.

journal_name

Diabetes Technol Ther

authors

Nimri R,Grosman B,Roy A,Nir J,Fisch Shvalb N,Kurtz N,Loewenthal N,Gillon-Keren M,Muller I,Atlas E,Phillip M

doi

10.1089/dia.2020.0448

subject

Has Abstract

pub_date

2020-12-08 00:00:00

eissn

1520-9156

issn

1557-8593

pub_type

杂志文章
  • Reduced weight gain with insulin detemir compared to NPH insulin is not explained by a reduction in hypoglycemia.

    abstract:BACKGROUND:Weight gain often occurs when insulin therapy is initiated. The long-acting insulin analog insulin detemir has been shown to be effective and well tolerated when used in basal-bolus regimens or as an add-on to oral antidiabetic drugs (OADs) and causes less weight gain than other insulins. The aim of this exp...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1089/dia.2008.0282

    authors: Davies MJ,Derezinski T,Pedersen CB,Clauson P

    更新日期:2008-08-01 00:00:00

  • The impact of initiating biphasic human insulin 30 therapy in type 2 diabetes patients after failure of oral antidiabetes drugs.

    abstract:BACKGROUND:The present study evaluated the efficacy of biphasic human insulin 30 (BHI 30) in type 2 diabetes patients who had failed in therapy with two or more oral antidiabetes drugs (OADs). METHODS:This open-label, nonrandomized, 4-month, multicenter, clinical observational study was conducted in Shanghai, China. A...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,多中心研究

    doi:10.1089/dia.2011.0168

    authors: Gu Y,Hou X,Zhang L,Pan J,Cai Q,Bao Y,Jia W

    更新日期:2012-03-01 00:00:00

  • Interactive educational diabetes/insulin tutorial at www.2aida.info.

    abstract::The World Wide Web now hosts a multitude of diabetes educational materials in various formats. Of particular interest is the diabetes/insulin tutorial available at the AIDA Website (accessible directly at: www.2aida.info). The tutorial combines textual or "static" information with an interactive diabetes simulator-AID...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2006.8.126

    authors: Reed K,Lehmann ED

    更新日期:2006-02-01 00:00:00

  • Daily glucose profiles in Japanese people with normal glucose tolerance as assessed by continuous glucose monitoring.

    abstract:BACKGROUND:Little information is available regarding glucose fluctuations in postprandial states and during the oral glucose tolerance test (OGTT) in Japanese people with normal glucose tolerance (NGT). METHODS:Glucose profiles of 27 Japanese people were measured for 4 days by using continuous glucose monitoring. A 75...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2008.0083

    authors: Tsujino D,Nishimura R,Taki K,Miyashita Y,Morimoto A,Tajima N

    更新日期:2009-07-01 00:00:00

  • An intelligent diabetes software prototype: predicting blood glucose levels and recommending regimen changes.

    abstract::Maintaining optimal blood glucose (BG) control is difficult for type 1 diabetes mellitus (T1DM) patients when typical daily regimens of food, insulin and exercise are altered. Artificial intelligence (AI) systems consisting of treatment algorithms calibrated through large datasets of patient specific information may o...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/15209150050501989

    authors: Otto E,Semotok C,Andrysek J,Basir O

    更新日期:2000-01-01 00:00:00

  • Minimally invasive insulin delivery in subjects with type 1 diabetes using hollow microneedles.

    abstract:BACKGROUND:Microneedles have previously been used to deliver insulin to animal models, but not in human subjects. This study tested the hypothesis that hollow microneedles can deliver insulin to modulate blood glucose levels in subjects with type 1 diabetes in a minimally invasive manner. METHODS:This study was carrie...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2008.0103

    authors: Gupta J,Felner EI,Prausnitz MR

    更新日期:2009-06-01 00:00:00

  • Analysis of continuous glucose monitoring data from non-diabetic and diabetic children: a tale of two algorithms.

    abstract::Use of the Medtronic MiniMed Continuous Glucose Monitoring System (CGMS) in non-diabetic children has revealed many low and high sensor glucose (SG) values, suggesting that the original analytical algorithm (Solutions 2.0) might be overreading glycemic excursions. A revised algorithm (Solutions 3.0) was introduced in ...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/152091503765691866

    authors: Weinzimer SA,DeLucia MC,Boland EA,Steffen A,Tamborlane WV

    更新日期:2003-01-01 00:00:00

  • Comparison of Second-Generation Basal Insulin Analogs: A Review of the Evidence from Continuous Glucose Monitoring.

    abstract::Many people with insulin-treated diabetes continue to experience inadequate glycemic control and a high incidence of hypoglycemic events, despite improvements in therapeutic strategies. While glycated hemoglobin (HbA1c) is currently recognized as the gold-standard for assessing glycemic control, the measure reflects m...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2020.0180

    authors: Battelino T,Edelman SV,Nishimura R,Bergenstal RM

    更新日期:2021-01-01 00:00:00

  • Continuous Subcutaneous Insulin Infusion in Neonates and Infants Below 1 Year: Analysis of Initial Bolus and Basal Rate Based on the Experiences from the German Working Group for Pediatric Pump Treatment.

    abstract:BACKGROUND:Diabetes mellitus is rare in young infants and neonates. Continuous subcutaneous insulin infusion (CSII) is used most frequently for insulin treatment in this age group. However, the individual doctor's experience is scarce because of the low prevalence of diabetes in this age. For this study patients treate...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,多中心研究

    doi:10.1089/dia.2015.0030

    authors: Kapellen TM,Heidtmann B,Lilienthal E,Rami-Merhar B,Engler-Schmidt C,Holl RW

    更新日期:2015-12-01 00:00:00

  • Proteomic identification of human urinary biomarkers in diabetes mellitus type 2.

    abstract:BACKGROUND:During the proteomic era, one of the most rapidly growing areas in biomedical research is biomarker discovery, particularly using proteomic technologies. The urinary proteome is known to be a valuable field of study and has become one of the most attractive subdisciplines in clinical proteomics for human dis...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,随机对照试验

    doi:10.1089/dia.2010.0078

    authors: Riaz S,Alam SS,Srai SK,Skinner V,Riaz A,Akhtar MW

    更新日期:2010-12-01 00:00:00

  • Intervention trials for prevention of metabolic syndrome and type 2 diabetes: focus on Asian Indians.

    abstract::Prevalence of diabetes continues to increase in urban areas, and escalation is discernible in semi-urban and rural areas. It is reported to affect Asian Indians a decade earlier compared with other populations, and complications (e.g., nephropathy) occur earlier and are severe and more prevalent than in other races. B...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,评审

    doi:10.1089/dia.2013.0373

    authors: Shrivastava U,Misra A

    更新日期:2014-08-01 00:00:00

  • Electroencephalography to assess motor control during balance tasks in people with diabetes.

    abstract:BACKGROUND:Balance is sensed through peripheral and central receptors and mediated by central control through the brain and spinal cord. Although some evidence exists as to the areas of the brain involved and how processing of data occurs in young individuals, nothing has been published on people with diabetes. The pur...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2012.0152

    authors: Petrofsky JS,Alshammari F,Lee H,Yim JE,Bains G,Khowailed IA,Deshpande PP,Potnis P,Tse F,Cavalcanti P

    更新日期:2012-11-01 00:00:00

  • Perioperative Characteristics of the Accuracy of Subcutaneous Continuous Glucose Monitoring: Pilot Study in Neurosurgery and Cardiac Surgery.

    abstract:BACKGROUND:The aim of this study was to elucidate the characteristics of accuracy of subcutaneous continuous glucose monitoring (SCGM) in the perioperative period for neurosurgical and cardiac surgery patients. METHODS:Forty-five subjects, including healthy volunteers (n = 15), neurosurgical patients (n = 15), and car...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2018.0140

    authors: Sugiyama Y,Wakabayashi R,Urasawa M,Maruyama Y,Shimizu S,Kawamata M

    更新日期:2018-10-01 00:00:00

  • Neural network-based real-time prediction of glucose in patients with insulin-dependent diabetes.

    abstract:BACKGROUND:Continuous glucose monitoring (CGM) technologies report measurements of interstitial glucose concentration every 5 min. CGM technologies have the potential to be utilized for prediction of prospective glucose concentrations with subsequent optimization of glycemic control. This article outlines a feed-forwar...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2010.0104

    authors: Pappada SM,Cameron BD,Rosman PM,Bourey RE,Papadimos TJ,Olorunto W,Borst MJ

    更新日期:2011-02-01 00:00:00

  • Association of DRD3, COMT, and SLC6A4 Gene Polymorphisms with Type 2 Diabetes in Southern Chinese: A Hospital-Based Case-Control Study.

    abstract:AIM:The aim of this study was to assess the associations of six single nucleotide polymorphisms (SNPs) of three genes (DRD3, COMT, and SCL6A4) with type 2 diabetes mellitus (T2DM) in Southern Chinese. SUBJECTS AND METHODS:Five hundred ninety-five cases with T2DM and 725 healthy controls of Han origin were recruited fr...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2014.0344

    authors: Xiu L,Lin M,Liu W,Kong D,Liu Z,Zhang Y,Ouyang P,Liang Y,Zhong S,Chen C,Jin X,Fan X,Qin J,Zhao X,Rao S,Ding Y

    更新日期:2015-08-01 00:00:00

  • The Effectiveness of Continuous Glucose Monitoring in Patients with Type 2 Diabetes: A Systematic Review of Literature and Meta-analysis.

    abstract:BACKGROUND:Continuous glucose monitoring (CGM) provides glucose trend information that can be used to guide treatment and motivate patients with diabetes. Currently, the evidence on effectiveness of CGM in patients with type 2 diabetes is debatable. We aim to provide a systematic review and meta-analysis to synthesize ...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,meta分析

    doi:10.1089/dia.2018.0177

    authors: Park C,Le QA

    更新日期:2018-09-01 00:00:00

  • Insulin Pump Settings During Breastfeeding in Women with Type 1 Diabetes.

    abstract:: Background: We aimed to explore insulin pump settings in breastfeeding women with type 1 diabetes. Methods: Thirteen unselected breastfeeding women with type 1 diabetes on insulin pump therapy were included consecutively from A...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2019.0280

    authors: Nørgaard SK,Nørgaard K,Roskjær AB,Mathiesen ER,Ringholm L

    更新日期:2020-04-01 00:00:00

  • NerveCheck for the Detection of Sensory Loss and Neuropathic Pain in Diabetes.

    abstract:BACKGROUND:Accurate and economic detection of nerve damage in diabetes is key to more widespread diagnosis of patients with diabetic peripheral neuropathy (DPN) and painful diabetic neuropathy. This study examined the diagnostic performance of NerveCheck, an inexpensive ($500) quantitative sensory testing (QST) device....

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2016.0279

    authors: Ponirakis G,Odriozola MN,Odriozola S,Petropoulos IN,Azmi S,Ferdousi M,Fadavi H,Alam U,Marshall A,Jeziorska M,Miro A,Kheyami A,Tavakoli M,Al-Ahmar A,Odriozola MB,Odriozola A,Malik RA

    更新日期:2016-12-01 00:00:00

  • Continuous glucose monitoring in patients undergoing cardiac surgery.

    abstract:OBJECTIVES:Hyperglycemia is a prominent feature among patients exposed to major stress such as in cardiac surgery. The implementation of a continuous glucose monitoring system (CGMS) for glucose monitoring during cardiac surgery was assessed. SUBJECTS AND METHODS:Fifty-nine consecutive patients who underwent cardiac s...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2011.0154

    authors: Kalmovich B,Bar-Dayan Y,Boaz M,Wainstein J

    更新日期:2012-03-01 00:00:00

  • Safety of drugs commonly used to treat hypertension, dyslipidemia, and Type 2 diabetes (the metabolic syndrome): part 2.

    abstract::It is becoming increasingly acknowledged that people with Type 2 Diabetes represent what can be termed "an enriched population": a group that has the greatest risk of morbidity and mortality from cardiovascular diseases such as myocardial infarcts and strokes. Due to the tremendous toll, both human and financial, that...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,评审

    doi:10.1089/15209150050025258

    authors: Marcus AO

    更新日期:2000-07-01 00:00:00

  • Family perceptions of insulin pump adverse events in children and adolescents.

    abstract:BACKGROUND:Insulin pumps (for continuous subcutaneous insulin infusion [CSII]) are used widely in type 1 diabetes mellitus. Although there has been considerable study of outcomes, there are few recent data on CSII-associated adverse events and no data on family perceptions of adverse events and their confidence in deal...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2013.0315

    authors: Wheeler BJ,Donaghue KC,Heels K,Ambler GR

    更新日期:2014-04-01 00:00:00

  • A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II.

    abstract:BACKGROUND:Persistent use of real-time continuous glucose monitoring (CGM) improves diabetes control in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D). METHODS:PRECISE II was a nonrandomized, blinded, prospective, single-arm, multicenter study that evaluated the accuracy and safety of the implantable...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,多中心研究

    doi:10.1089/dia.2017.0142

    authors: Christiansen MP,Klaff LJ,Brazg R,Chang AR,Levy CJ,Lam D,Denham DS,Atiee G,Bode BW,Walters SJ,Kelley L,Bailey TS

    更新日期:2018-03-01 00:00:00

  • Use of an internet-based telemedicine system to manage underserved women with gestational diabetes mellitus.

    abstract:BACKGROUND:Internet technology has been proven to be a successful tool for the management of patients with multiple medical conditions. The purpose of this study was to demonstrate the feasibility of monitoring glucose control in indigent women with gestational diabetes mellitus (GDM) over the Internet. METHODS:Women ...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,随机对照试验

    doi:10.1089/dia.2006.0034

    authors: Homko CJ,Santamore WP,Whiteman V,Bower M,Berger P,Geifman-Holtzman O,Bove AA

    更新日期:2007-06-01 00:00:00

  • Effect of vildagliptin on glucose and insulin concentrations during a 24-hour period in type 2 diabetes patients with different ranges of baseline hemoglobin A1c levels.

    abstract:BACKGROUND:Currently, it is still unknown whether differences in glycemic control have any effect on glucose and insulin kinetics after vildagliptin administration. The aim of this study was to evaluate the effect of vildagliptin on glucose and insulin concentrations during a 24-h period in type 2 diabetes patients wit...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,随机对照试验

    doi:10.1089/dia.2013.0020

    authors: González-Ortiz M,Sánchez-Peña MJ,González-Ortiz LJ,Robles-Cervantes JA,García-Ortega YE,Gómez-Gaitán EA,Pérez-Rubio KG,Martínez-Abundis E

    更新日期:2013-07-01 00:00:00

  • Feasibility of continuous subcutaneous insulin infusion and daily supplemental insulin glargine injection in children with type 1 diabetes.

    abstract:BACKGROUND:Continuous subcutaneous insulin infusion (CSII) is an effective method of insulin substitution with increased risk of hypoglycemia and diabetic ketoacidosis (DKA) in rare situations. The lack of subcutaneous long-acting insulin and short half-life of serum insulin increases the risk of ketosis and DKA follow...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2008.0124

    authors: Alemzadeh R,Parton EA,Holzum MK

    更新日期:2009-08-01 00:00:00

  • Cardiovascular disease in children and adolescents with diabetes: where are we, and where are we going?

    abstract::The increasing prevalence of type 1 and type 2 diabetes mellitus combined with advancement in early detection of cardiovascular disease (CVD) has placed CVD as a significant concern for preventative pediatric medicine. The public health burden of type 2 diabetes is predicted to parallel increasing obesity in children ...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,评审

    doi:10.1089/dia.2012.0018

    authors: Truong UT,Maahs DM,Daniels SR

    更新日期:2012-06-01 00:00:00

  • Continuous glucose monitoring by means of the microdialysis technique: underlying fundamental aspects.

    abstract::The microdialysis technique allows extraction of substances (e.g., glucose) from fluids in the human body for quantitative measurements ex vivo. The microdialysis catheter can be inserted in many different tissues; for continuous glucose monitoring it is most often implanted in the subcutaneous fat tissue in the abdom...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,评审

    doi:10.1089/152091503322250578

    authors: Heinemann L,Glucose Monitoring Study Group.

    更新日期:2003-01-01 00:00:00

  • Real-World Hypoglycemia Avoidance with a Continuous Glucose Monitoring System's Predictive Low Glucose Alert.

    abstract:BACKGROUND:Programmable and fixed auditory and/or vibratory threshold alerts are essential features of real-time continuous glucose monitoring (rtCGM) systems that provide users time to intervene before the onset of clinical hypoglycemia or hyperglycemia. A sixth-generation rtCGM system from Dexcom, Inc. (G6) includes ...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2018.0359

    authors: Puhr S,Derdzinski M,Welsh JB,Parker AS,Walker T,Price DA

    更新日期:2019-04-01 00:00:00

  • Efficacy and Tolerability of Exenatide Once Weekly Over 6 Years in Patients with Type 2 Diabetes: An Uncontrolled Open-Label Extension of the DURATION-1 Study.

    abstract:BACKGROUND:Long-term treatment is necessary to slow the progression of type 2 diabetes (T2D). Here, we examined the safety and efficacy of 6 years of treatment with exenatide once weekly (QW) among patients with T2D in the DURATION-1 trial. METHODS:The study enrolled patients aged ≥16 years with T2D treated primarily ...

    journal_title:Diabetes technology & therapeutics

    pub_type: 临床试验,杂志文章

    doi:10.1089/dia.2016.0107

    authors: Henry RR,Klein EJ,Han J,Iqbal N

    更新日期:2016-11-01 00:00:00

  • Defining High Glycemic Variability in Type 1 Diabetes: Comparison of Multiple Indexes to Identify Patients at Risk of Hypoglycemia.

    abstract:: Background: International consensus on the use of continuous glucose monitoring (CGM) recommends coefficient of variation (CV) as the metric of choice to express glycemic variability (GV) with a cutoff of 36% to define unstable diabetes. Even though, CV is associated with ...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2019.0075

    authors: Gómez AM,Henao DC,Imitola Madero A,Taboada LB,Cruz V,Robledo Gómez MA,Rondón M,Muñoz-Velandia O,García-Jaramillo M,León Vargas FM

    更新日期:2019-08-01 00:00:00