Abstract:
BACKGROUND:There is an unmet need for a modular artificial pancreas (AP) system for clinical trials within the existing regulatory framework to further AP research projects from both academia and industry. We designed, developed, and tested the interoperable artificial pancreas system (iAPS) smartphone app that can interface wirelessly with leading continuous glucose monitors (CGM), insulin pump devices, and decision-making algorithms while running on an unlocked smartphone. METHODS:After algorithm verification, hazard and mitigation analysis, and complete system verification of iAPS, six adults with type 1 diabetes completed 1 week of sensor-augmented pump (SAP) use followed by 48 h of AP use with the iAPS, a Dexcom G5 CGM, and either a Tandem or Insulet insulin pump in an investigational device exemption study. The AP system was challenged by participants performing extensive walking without exercise announcement to the controller, multiple large meals eaten out at restaurants, two overnight periods, and multiple intentional connectivity interruptions. RESULTS:Even with these intentional challenges, comparison of the SAP phase with the AP study showed a trend toward improved time in target glucose range 70-180 mg/dL (78.8% vs. 83.1%; P = 0.31), and a statistically significant reduction in time below 70 mg/dL (6.1% vs. 2.2%; P = 0.03). The iAPS system performed reliably and showed robust connectivity with the peripheral devices (99.8% time connected to CGM and 94.3% time in closed loop) while requiring limited user intervention. CONCLUSIONS:The iAPS system was safe and effective in regulating glucose levels under challenging conditions and is suitable for use in unconstrained environments.
journal_name
Diabetes Technol Therjournal_title
Diabetes technology & therapeuticsauthors
Deshpande S,Pinsker JE,Zavitsanou S,Shi D,Tompot R,Church MM,Andre C,Doyle FJ 3rd,Dassau Edoi
10.1089/dia.2018.0278subject
Has Abstractpub_date
2019-01-01 00:00:00pages
35-43issue
1eissn
1520-9156issn
1557-8593journal_volume
21pub_type
杂志文章abstract::Chromium (Cr) picolinate (CrPic) is a widely used nutritional supplement for optimal insulin function. A relationship among Cr status, diabetes, and associated pathologies has been established. Virtually all trials using CrPic supplementation for subjects with diabetes have demonstrated beneficial effects. Thirteen of...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2006.8.677
更新日期:2006-12-01 00:00:00
abstract::Chronic hyperglycemia, as assessed by hemoglobin A1c (HbA1c) levels, has been associated with the development of microvascular and macrovascular complications of diabetes. Several studies have shown that acute hyperglycemia can add to the effect of chronic hyperglycemia in inducing tissue damage. Acute hyperglycemia c...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2010.0146
更新日期:2011-03-01 00:00:00
abstract:AIMS:This study compared glycemic control and maternal and fetal outcomes in pregnant women with type 1 diabetes mellitus (T1DM) treated with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) using regular (RI) or lispro (LP) insulin. METHODS:Three hundred fifteen consecutive singleton...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2010.0111
更新日期:2010-12-01 00:00:00
abstract:BACKGROUND:Lipohypertrophy (LH) is a complication of insulin therapy. We assessed LH prevalence, risk factors, insulin usage, and clinical and health economic effects in China. METHODS:In four cities, 401 adult patients injecting insulin ≥1 year were surveyed for diabetes/insulin injection history and practices, pen n...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2016.0334
更新日期:2017-01-01 00:00:00
abstract:BACKGROUND:Continuous glucose monitoring (CGM) has been shown to be a valuable tool to improve glycemic control in patients with diabetes. The objective of this pilot study was to develop and implement CGM in an existing diabetes clinic for low-income patients on multiple daily injections. SUBJECTS AND METHODS:This wa...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1089/dia.2013.0072
更新日期:2013-10-01 00:00:00
abstract:AIM:Insulin therapy induces remission in subjects with newly diagnosed type 2 diabetes mellitus (T2DM). This study assessed the insulin and C-peptide levels in newly diagnosed T2DM subjects during low-dose insulin therapy. SUBJECTS AND METHODS:Twenty newly diagnosed, drug-naive, T2DM patients without acute or chronic ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2010.0187
更新日期:2011-04-01 00:00:00
abstract:BACKGROUND:SAR342434 is a biosimilar follow-on of insulin lispro-Humalog®. This study aimed to show similar efficacy, safety, and immunogenicity of SAR342434 (SAR-Lis) versus insulin lispro-Humalog (Ly-Lis) in adult patients with type 1 diabetes (T1DM) treated with multiple daily injections while using basal insulin gl...
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.2017.0117
更新日期:2017-09-01 00:00:00
abstract:BACKGROUND:Diabetic foot ulcer area is a basic parameter used for monitoring the wound healing and effectiveness of the treatment applied. TeleDiaFoS (developed earlier in collaboration with the Department and Clinic of Gastroenterology and Metabolic Diseases, Medical University of Warsaw, Warsaw, Poland) is one of jus...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2011.0082
更新日期:2011-11-01 00:00:00
abstract:BACKGROUND:The purpose of this study was to evaluate the performance of an insulin infusion protocol targeting a blood glucose (BG) level of 140-180 mg/dL and to characterize protocol adherence. MATERIALS AND METHODS:This was a retrospective observational cohort study including patients for whom the protocol was order...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2015.0046
更新日期:2016-02-01 00:00:00
abstract::Diabetic nephropathy is one of the major causes of end-stage renal disease and is often associated with other macrovascular complications such as ischemic heart disease and peripheral vascular disease. Angiotensin converting enzyme inhibitors (ACE-I) and angiotensin II receptor blockers (AIIR) have both been shown to ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/152091502760098456
更新日期:2002-01-01 00:00:00
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
更新日期:2014-08-01 00:00:00
abstract::Since the late 1970s, self-monitoring of blood glucose has been the standard for assessing daily glycemic control. The first continuous glucose monitor became available in 1999. Numerous clinical trials have documented the benefits of continuous glucose monitoring (CGM) in patients with type 1 diabetes mellitus (DM). ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2011.0086
更新日期:2012-02-01 00:00:00
abstract::By the year 2030, the diabetes pandemic will likely affect more than 10% of the world's population. The personal, public health, and economic crises implicit in this trend call for decisive action. Yet, escalating dilemmas thwart full realization of current therapies. First, controversial studies, such as the Action t...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2012.0132
更新日期:2012-11-01 00:00:00
abstract::Innovo (Novo Nordisk A/S, Hillerød, Denmark) is a new insulin injection system that offers built-in memory and a large, clear display to provide patients with more control during insulin injections. The aim of this trial was to compare the efficacy and safety of Innovo and NovoPen 3 (Novo Nordisk A/S) in patients expe...
journal_title:Diabetes technology & therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1089/152091504322783413
更新日期:2004-02-01 00:00:00
abstract:BACKGROUND:The efficacy of short-term professional continuous glucose monitoring (CGM) for glycemic control in patients with diabetes remains unclear. METHODS:We performed a 3-month study to evaluate the benefits of CGM in 64 patients. RESULTS:The overall glycemic control of patients who underwent CGM improved signif...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2018.0164
更新日期:2018-09-01 00:00:00
abstract:BACKGROUND:This study explored the relationships between exogenous insulin requirements and endogenous variables in elderly patients with type 2 diabetes (T2D). SUBJECTS AND METHODS:Patients with T2D 65 years of age or older were enrolled for a short hospitalization period in order to start or change their basal-bolus...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2015.0044
更新日期:2016-05-01 00:00:00
abstract::The foreign body capsule that forms around implanted devices such as glucose sensors is hypovascular and has limited permeability to glucose. Such a capsule may function better if well vascularized. We hypothesized that capsular vascularization achieved by local release of vascular endothelial growth factor (VEGF) wou...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/152091504773731320
更新日期:2004-04-01 00:00:00
abstract:BACKGROUND:As healthy diet and physical activity can improve glucometabolic control in patients with type 2 diabetes, lifestyle changes should be the basis for each therapy. The only tool to visualize immediate effects of food pattern and exercise on blood glucose levels is self-monitoring of blood glucose (SMBG). Ther...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2010.0008
更新日期:2010-07-01 00:00:00
abstract:: Background: FreeStyle Libre is a factory-calibrated continuous 14-day glucose sensor. Little is known about the accuracy of FreeStyle Libre as a function of sensor age. Methods: We assessed the accuracy of FreeStyle Libre in 14...
journal_title:Diabetes technology & therapeutics
pub_type: 临床试验,杂志文章
doi:10.1089/dia.2019.0262
更新日期:2020-03-01 00:00:00
abstract:BACKGROUND:Skin autofluorescence (AF) as measured with the AGE Reader (DiagnOptics Technologies, Groningen, The Netherlands) is a noninvasive prognostic marker in diabetes mellitus and other diseases with increased cardiovascular risk. This study provides reference values of healthy Caucasian control subjects as a func...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2009.0113
更新日期:2010-05-01 00:00:00
abstract::Recent years have brought about an explosion in the number of companies offering connected diabetes care products, defined as digital diabetes management systems based around (1) smartphone apps, (2) devices with built-in connectivity, and (3) remote human and automated coaching and support. These nascent models aim t...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2019.0273
更新日期:2020-01-01 00:00:00
abstract::Hyperspectral imaging (HSI) has been useful in monitoring several medical conditions, which to date have generally involved local changes in skin oxygenation of isolated regions of interest such as skin flaps or small burns. Here, by contrast, we present a study in which HSI was used to assess the local cutaneous mani...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/152091503322527058
更新日期:2003-01-01 00:00:00
abstract::Thanks to significant improvements in the precision, accuracy, and usability of continuous glucose monitoring (CGM), its relevance in both ambulatory diabetes care and clinical research is increasing. In this study, we address the latter perspective and derive provisional reporting recommendations. CGM systems have be...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2017.0054
更新日期:2017-07-01 00:00:00
abstract:BACKGROUND:Relatively little is known about parents' or children's attitudes toward recruitment for, and participation in, studies of new diabetes technologies immediately after diagnosis. This study investigated factors affecting recruitment of participants for studies in newly diagnosed youth with type 1 diabetes. M...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2016.0157
更新日期:2016-09-01 00:00:00
abstract:AIMS:Skin autofluorescence (AF) has been associated with complications of diabetes. We evaluated the influence of skin color and ethnicity on the association between skin AF and the presence of diabetes-related complications. MATERIALS AND METHODS:In a multiethnic type 2 diabetes cohort we investigated all patients wi...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2013.0374
更新日期:2015-02-01 00:00:00
abstract:: Objective: To assess the degree, duration, mean absolute relative difference (MARD), and error analysis of discrepant values per continuous glucose monitoring (CGM) systems after hydroxyurea (HU) administration. Research Design and Methods: ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2020.0490
更新日期:2020-12-30 00:00:00
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
更新日期:2018-03-01 00:00:00
abstract:OBJECTIVE:This study was designed to develop predictive formulas for precise insulin dosing in young children with type 1 diabetes (T1DM). RESEARCH DESIGN AND METHODS:Consecutive 1-year data from a group of 14 young patients (eight girls, six boys) 3.9 ± 0.8 years old with diabetes duration of 2.0 ± 0.8 years, transit...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2011.0184
更新日期:2012-05-01 00:00:00
abstract:BACKGROUND:The value of self-monitoring of blood glucose (SMBG) for persons with type 2 diabetes who do not use insulin remains controversial. This observational study compares the likelihood of medication adherence and change in glycated hemoglobin (A1C) for non-insulin-using patients using SMBG versus those not using...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2012.0047
更新日期:2012-09-01 00:00:00
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
更新日期:2019-08-01 00:00:00