Abstract:
BACKGROUND:This exploratory study examined the pharmacokinetics and pharmacodynamics of a Bentley Pharmaceuticals, Inc. (North Hampton, NH) proprietary insulin formulation utilizing CPE-215 technology designed for intranasal administration. METHODS:Eight fasting healthy volunteers (four men, four women; body mass index, 23.6 +/- 1.7 kg/m2) received up to four doses of intranasal insulin at least 1 week apart. Serum insulin, C-peptide, and plasma glucose were measured in the 4-h period following administration. RESULTS:At doses of 18.75 IU and above, a rise in serum insulin levels accompanied by a decrease in plasma glucose and serum C-peptide levels was seen. Insulin levels peaked in 10-20 min and remained elevated for approximately 1 h, and the resultant hypoglycaemic effect peaked at 40 min and returned to normal 1.5-2 h post-dosing. At 25 IU (n = 11 doses; eight subjects with three replicates), there was a mean fall in plasma glucose of 20.49%; a greater fall in plasma glucose was seen with higher insulin doses. In addition, mean peak insulin levels increased with dose escalation. For the 25 IU dose (a single 90-microL spray), the maximum measured insulin concentration was 19.52 +/- 9.28 mIU/L, and the area under the concentration-time curve from 0 to 4 h was 19.06 +/- 5.56 mIU/L/h. Three subjects with repeated 25 IU doses demonstrated similarly reproducible peaks for maximum measured insulin concentration and for plasma glucose reductions. As seen with other insulin studies, the inter-individual responsiveness to insulin was variable. CONCLUSIONS:This intranasal formulation was generally well tolerated and demonstrated rapid onset of action and appropriate duration of action for the potential use in controlling postprandial hyperglycaemia.
journal_name
Diabetes Technol Therjournal_title
Diabetes technology & therapeuticsauthors
Leary AC,Stote RM,Breedt HJ,O'Brien J,Buckley Bdoi
10.1089/dia.2005.7.124keywords:
subject
Has Abstractpub_date
2005-02-01 00:00:00pages
124-30issue
1eissn
1520-9156issn
1557-8593journal_volume
7pub_type
临床试验,杂志文章abstract:BACKGROUND:The junction of telemedicine home monitoring with multifaceted disease management programs seems nowadays a promising direction to combine the need for an intensive approach to deal with diabetes and the pressure to contain the costs of the interventions. Several projects in the European Union and the United...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2004.6.567
更新日期:2004-10-01 00:00:00
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journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,多中心研究
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abstract:OBJECTIVE:Exercise is a cornerstone of diabetes therapy in type 1 diabetes mellitus (DMT1) patients. The type of exercise is important in determining the propensity to hypoglycemia. We assessed, by continuous glucose monitoring (CGM), the glucose profiles during and in the following 20h after a session of two different...
journal_title:Diabetes technology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:2010-10-01 00:00:00
abstract::Treatments for type 1 diabetes have advanced significantly over recent years. There are now multiple hybrid closed-loop systems commercially available and additional systems are in development. Challenges remain, however. This review outlines the recent advances in closed-loop systems and outlines the remaining challe...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2019.0469
更新日期:2020-07-01 00:00:00
abstract:BACKGROUND:The Optimizing Control in Diabetes (OPTIMIZE) survey was conducted to understand the patients' perspective to achieving good glycemic control and to determine how patients' perceptions of insulin may affect their decisions to initiate or intensify their insulin therapy. METHODS:A total of 1,444 subjects wit...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1089/dia.2008.0249
更新日期:2008-02-01 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: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::Measuring the hemoglobin A(1c) (HbA(1c)) is the standard-of-care method to assess long-term glycemic control of patients with diabetes, describing the average glycemic level. However, the HbA(1c) does not reflect acute fluctuations in glucose levels. Variability of glycemia probably has an impact on the development of...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2008.0119
更新日期:2009-06-01 00:00:00
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journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
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更新日期:2010-11-01 00:00:00
abstract:BACKGROUND:Faster aspart is insulin aspart (IAsp) in a new formulation, which in continuous subcutaneous insulin infusion (CSII) in subjects with type 1 diabetes has shown a faster onset and offset of glucose-lowering effect than IAsp. METHODS:This double-blind, randomized, crossover active-controlled trial compared 2...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
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更新日期:2017-01-01 00:00:00
abstract:BACKGROUND:Implanted insulin pumps using the peritoneal route provide long-term improvement of glucose control compared with subcutaneous insulin therapy in type 1 diabetes (T1D) patients. The stability of insulin preparation is critical for a safe use in implanted pumps. Insuman implantable(®) (400 IU/mL) (Sanofi-Aven...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
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更新日期:2014-09-01 00:00:00
abstract:BACKGROUND:Computer simulation environments have been used in the development of many artificial pancreas systems. A glucose sensor model is an essential part of these environments, and different models have been proposed. However, not one of these models accounts for drop-outs of sensor readings, a well-known phenomen...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2014.0309
更新日期:2015-06-01 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:BACKGROUND:The aim of this investigation was to assess clinical predictors of the glycosylated hemoglobin (HbA1C) response after the addition of a thiazolidinedione (TZD) to a biguanide, a sulfonylurea, or both in subjects with type 2 diabetes. METHODS:Chart review (n = 68 physicians) was used to identify consecutive ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2007.0248
更新日期:2007-12-01 00:00:00
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
更新日期:2013-07-01 00:00:00
abstract:BACKGROUND:This article reports a prolonged trial with insulin pumps implanted in patients with type 1 diabetes showing poor glucose control and a high rate of complications. METHODS:We reviewed data from 181 patients undergoing implanted insulin pump therapy. Analysis included hemoglobin A1c (HbA1c) values, body weig...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2010.0209
更新日期:2011-06-01 00:00:00
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
更新日期:2000-01-01 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:Prediction of glycemic profile is an important task for both early recognition of hypoglycemia and enhancement of the control algorithms for optimization of insulin infusion rate. Adaptive models for glucose prediction and recognition of hypoglycemia based on statistical and artificial intelligence technique...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2011.0093
更新日期:2012-02-01 00:00:00
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
更新日期:2015-12-01 00:00:00
abstract:BACKGROUND:Continuous glucose monitoring (CGM) has been shown to improve glycemic control and reduce hypoglycemia with consistent use. Youth, however, are unlikely to use CGM consistently. We compared psychological characteristics of youth with type 1 diabetes, their parents, and adults with type 1 diabetes randomized ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
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更新日期:2012-06-01 00:00:00
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journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2016.0279
更新日期:2016-12-01 00:00:00
abstract::Laser retinal photocoagulation represents the primary therapy for the potentially blinding manifestations of diabetic retinopathy. Advances in laser therapy for diabetic eye disease have arisen from the convergence of laser technology and clinical ophthalmology. In this review, the basis of laser therapy in diabetic r...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
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更新日期:1999-07-01 00:00:00
abstract::Current clinical guidelines for diabetes care encourage self-monitoring of blood glucose (SMBG) to improve glycemic control. Specific protocols remain variable, however, particularly among non-insulin-using patients. This is due in part to efficacy studies that neglect to consider (1) the performance of monitoring equ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2008.0104
更新日期:2008-12-01 00:00:00
abstract:OBJECTIVE:This study assessed the association of serum adiponectin with carotid intimal medial thickness (IMT) in Asian Indians with different grades of glucose intolerance. METHODS:Subjects with normal glucose tolerance (NGT) (n = 520), impaired glucose tolerance (IGT) (n = 115), and type 2 diabetes mellitus (T2DM) (...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2009.0100
更新日期:2010-02-01 00:00:00
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
更新日期:2009-07-01 00:00:00
abstract:BACKGROUND:The management of hyperglycemia in the intensive care unit has been a controversial topic for more than a decade, with target ranges varying from 80-110 mg/dL to <200 mg/dL. Multiple insulin infusion protocols exist, including several computerized protocols, which have attempted to achieve these targets. Imp...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2016.0101
更新日期:2016-08-01 00:00:00
abstract:BACKGROUND:Lipoprotein-associated phospholipase A₂ (Lp-PLA₂) is a lipoprotein-associated enzyme that cleaves oxidized phosphatidylcholines, generating pro-atherosclerotic lysophosphatidylcholine and oxidized free fatty acids. Lp-PLA₂ is independently associated with cardiovascular disease (CVD) in a variety of populati...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2010.0175
更新日期:2011-03-01 00:00:00
abstract::Most previous attempts at the development of a "smart tattoo" for glucose monitoring in diabetes--implantable fluorescent microspheres that can be implanted intradermally and interrogated transdermally using light--have focused on the encapsulation of a competitive binding assay for glucose within hydrogel microsphere...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2006.8.288
更新日期:2006-06-01 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