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Article: Efficacy and Safety of Ultra-Rapid Lispro in Younger and Older Patients with Type 2 Diabetes: Randomized Double-Blind PRONTO-T2D Study.

Zhang, Qianyi / Chigutsa, Farai / Chang, Annette M

Diabetes therapy : research, treatment and education of diabetes and related disorders

2022 Volume 13, Issue 8, Page(s) 1547–1557

Abstract: Introduction: Ultra-rapid lispro (URLi) is a new prandial insulin lispro formulation. In the PRONTO-T2D study, URLi, in a basal-bolus regimen with glargine or degludec, was non-inferior to lispro (Humalog: Methods: PRONTO-T2D was a phase 3, 26-week, ... ...

Abstract	Introduction: Ultra-rapid lispro (URLi) is a new prandial insulin lispro formulation. In the PRONTO-T2D study, URLi, in a basal-bolus regimen with glargine or degludec, was non-inferior to lispro (Humalog Methods: PRONTO-T2D was a phase 3, 26-week, double-blind, treat-to-target study in people with type 2 diabetes. In this sub-group analysis, we compared URLi to lispro on the change from baseline in HbA1c and rate of level 2 hypoglycemia (< 54 mg/dl) in patients aged < 65 (N = 406) and ≥ 65 years (N = 267). Results: At baseline, patients < 65 versus ≥ 65 years had mean age of 54.9 versus 69.2 years and duration of diabetes 14.6 versus 19.4 years. Mean HbA1c at screening and randomization was 8.35 and 7.34%, respectively, in patients < 65 years, and 8.21 and 7.23%, respectively, in patients ≥ 65 years. At endpoint, mean HbA1c with URLi versus lispro was 6.92 versus 6.90%, respectively, in patients < 65 years and 6.89 versus 6.79%, respectively, in patients ≥ 65 years. URLi significantly reduced 1- and 2-h PPG excursions with a standardized meal test in both age groups: between-treatment differences at 1-h postmeal for younger and older patients was - 9.8 and - 15.1 mg/dl, respectively; and at 2-h postmeal, - 18.7 and - 15.1 mg/dl, respectively, all p < 0.05. Severe and nocturnal hypoglycemia were similar between groups. The relative rate (URLi/Humalog) of level 2 hypoglycemia was lower in older versus younger patients, with a significant treatment-by-age interaction observed. No differential treatment effects were noted for insulin dose, weight, and fasting and maximum glucose after the meal test. Conclusions: URLi, in a basal-bolus regimen, resulted in endpoint HbA1c < 7% and significantly lower PPG excursions compared to lispro in both age groups, with reduced level 2 hypoglycemia in older versus younger patients. Trial registration: ClinicalTrials.gov, NCT03214380.
Language	English
Publishing date	2022-07-04
Publishing country	United States
Document type	Journal Article
ZDB-ID	2566702-6
ISSN	1869-6961 ; 1869-6953
ISSN (online)	1869-6961
ISSN	1869-6953
DOI	10.1007/s13300-022-01290-4
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Assessing Time in Range with Postprandial Glucose-Focused Titration of Ultra Rapid Lispro (URLi) in People with Type 1 Diabetes.

Bergenstal, Richard M / Bode, Bruce W / Bhargava, Anuj / Wang, Qianqian / Knights, Alastair W / Chang, Annette M

Diabetes therapy : research, treatment and education of diabetes and related disorders

2023 Volume 14, Issue 11, Page(s) 1933–1945

Abstract: Introduction: To assess time in range (TIR) (70-180 mg/dL) with postprandial glucose (PPG)-focused titration of ultra rapid lispro (URLi; Lyumjev®) in combination with insulin degludec in people with type 1 diabetes (T1D).: Methods: This phase 2, ... ...

Abstract	Introduction: To assess time in range (TIR) (70-180 mg/dL) with postprandial glucose (PPG)-focused titration of ultra rapid lispro (URLi; Lyumjev®) in combination with insulin degludec in people with type 1 diabetes (T1D). Methods: This phase 2, single-group, open-label, exploratory study was conducted in 31 participants with T1D on multiple daily injection therapy. Participants were treated with insulin degludec and Lispro for an 11-day lead-in and then URLi for a 46-day treatment period consisting of 35-day titration and 11-day endpoint maintenance period. Glucose targets for the titration period were PPG < 140 mg/dL or < 20% increase from premeal, fasting glucose 80-110 mg/dL, and overnight excursion ± 30 mg/dL or less. Participants used the InPen™ bolus calculator and Dexcom G6 continuous glucose monitoring (CGM). Results: Primary endpoint mean TIR (70-180 mg/dL) with URLi during the maintenance period was 70.2%. TIR (70-180 mg/dL) and times below/above range were not significantly different with URLi (maintenance) versus lispro (lead-in). HbA1c decreased from 7.1% at screening to 6.8% at endpoint (least squares mean [LSM] change from baseline, - 0.36%; P < 0.001). Fructosamine and 1,5-anhydroglucitol improved (P < 0.001). Mean hourly glucose using CGM was reduced from 8:00 AM to 4:00 PM with URLi. Overall highest PPG excursion across meals was significantly reduced at URLi endpoint compared with lispro lead-in (mean 56.5 vs 72.4 mg/dL; P < 0.001). Insulin-to-carbohydrate ratio (U/X g) was reduced (more insulin given) at breakfast at URLi endpoint vs lead-in (LSM 9.0 vs 9.7 g; P = 0.002) and numerically decreased at other meals. Total daily insulin dose (TDD) was higher at URLi endpoint compared with lispro lead-in (mean 50.2 vs 47.0 U; P = 0.046) with similar prandial/TDD ratio (mean 52.1% vs 51.2%). There were no severe hypoglycemia events during the study. Conclusions: URLi in a basal-bolus regimen focusing on PPG targets demonstrated improved overall glycemic control and reduced PPG excursions without increased hypoglycemia in participants with T1D. Trial registration: ClinicalTrial.gov, NCT04585776.
Language	English
Publishing date	2023-09-23
Publishing country	United States
Document type	Journal Article
ZDB-ID	2566702-6
ISSN	1869-6961 ; 1869-6953
ISSN (online)	1869-6961
ISSN	1869-6953
DOI	10.1007/s13300-023-01476-4
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Article: Increased Time in Range with Ultra Rapid Lispro Treatment in Participants with Type 2 Diabetes: PRONTO-Time in Range.

Bailey, Timothy S / Bode, Bruce W / Wang, Qianqian / Knights, Alastair W / Chang, Annette M

Diabetes therapy : research, treatment and education of diabetes and related disorders

2023 Volume 14, Issue 5, Page(s) 883–897

Abstract: Introduction: To evaluate time in range metrics and HbA1c in people with type 2 diabetes (T2D) treated with ultra rapid lispro (URLi) using continuous glucose monitoring (CGM) for the first time in this population.: Methods: This was a Phase 3b, 12- ... ...

Abstract	Introduction: To evaluate time in range metrics and HbA1c in people with type 2 diabetes (T2D) treated with ultra rapid lispro (URLi) using continuous glucose monitoring (CGM) for the first time in this population. Methods: This was a Phase 3b, 12-week, single-treatment study in adults with T2D on basal-bolus multiple daily injection (MDI) therapy using basal insulin glargine U-100 along with a rapid-acting insulin analog. Following a 4-week baseline period, 176 participants were newly treated with prandial URLi. Participants used unblinded CGM (Freestyle Libre). Primary endpoint was time in range (TIR) (70-180 mg/dl) during the daytime period at Week 12 compared to baseline with gated secondary endpoints of HbA1c change from baseline and 24-h TIR (70-180 mg/dl). Results: Improved glycemic control was observed at Week 12 versus baseline including mean daytime TIR (change from baseline [Δ] 3.8%; P = 0.007), HbA1c (Δ - 0.44%; P < 0.001), and 24-h TIR (Δ 3.3%; P = 0.016) with no significant difference in time below range (TBR). After 12 weeks, there was a statistically significant decrease in postprandial glucose incremental area under curve, overall, across all meals, within 1 h (P = 0.005) or 2 h (P < 0.001) after the start of a meal. Basal, bolus, and total insulin dose were intensified with increased bolus/total dose ratio at Week 12 (50.7%) versus baseline (44.5%; P < 0.001). There were no severe hypoglycemia events during the treatment period. Conclusions: In people with T2D, URLi in an MDI regimen was efficacious with improved glycemic control including TIR, HbA1c, and postprandial glucose without increased hypoglycemia/TBR. CLINICAL TRIAL REGISTRATION NUMBER: NCT04605991.
Language	English
Publishing date	2023-04-07
Publishing country	United States
Document type	Journal Article
ZDB-ID	2566702-6
ISSN	1869-6961 ; 1869-6953
ISSN (online)	1869-6961
ISSN	1869-6953
DOI	10.1007/s13300-023-01400-w
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Article ; Online: Fasting and postprandial plasma glucose contributions to hemoglobin A1c and time in range in people with diabetes on multiple daily injection insulin therapy: Results from the PRONTO-T1D and PRONTO-T2D clinical trials.

Piras de Oliveira, Carolina / Dellva, Mary Anne / Bue-Valleskey, Juliana / Chang, Annette M / Liao, Birong

Journal of diabetes and its complications

2023 Volume 38, Issue 1, Page(s) 108648

Abstract: Aims: To investigate contributions of changes in fasting plasma glucose (FPG) and postprandial glucose (PPG) to changes in hemoglobin A1c (HbA1c) and time-in-range (TIR, 70-180 mg/dL) in people with type 1 diabetes (T1D) and type 2 diabetes (T2D) ... ...

Abstract	Aims: To investigate contributions of changes in fasting plasma glucose (FPG) and postprandial glucose (PPG) to changes in hemoglobin A1c (HbA1c) and time-in-range (TIR, 70-180 mg/dL) in people with type 1 diabetes (T1D) and type 2 diabetes (T2D) treated with multiple daily injections (MDI) of insulin lispro (rapid/ultra-rapid formulations). Methods: Multivariate regression models were used to quantify the contributions of FPG and PPG reductions to change in HbA1c and TIR using data from the PRONTO-T1D (N = 1222) and PRONTO-T2D (N = 673) clinical trials. TIR was derived from 10-point self-monitored blood glucose (SMBG) profiles overall, as well as from continuous glucose monitoring (CGM) in the PRONTO-T1D CGM substudy (n = 269/1222). Results: A 1 mmol/L FPG reduction corresponded with a 0.09-0.12 % (95 % confidence interval [CI] 0.06-0.15 %) HbA1c reduction in PRONTO-T1D and 0.17-0.26 % (95 % CI 0.13-0.30 %) in PRONTO-T2D (both p < 0.0001). A 1 mmol/L PPG reduction corresponded with a 0.05-0.09 % (95 % CI 0.01-0.12 %) HbA1c reduction in PRONTO-T1D (p < 0.001) and 0.10-0.15 % (95 % CI 0.05-0.19 %) in PRONTO-T2D (p < 0.0001). Reductions in FPG and PPG were significantly associated with increased TIR whether derived from SMBG (7.87-12.95 % [95 % CI 6.81-14.23 %]; all p < 0.0001) or CGM (3.35-4.18 % [95 % CI 2.11-5.39 %]; all p < 0.05). Conclusions: FPG and PPG significantly impact HbA1c and TIR. Balanced management of both FPG and PPG is important to achieve glycemic goals for people with diabetes on MDI insulin therapy. Clinical trials registration: PRONTO-T1D ClinicalTrials.gov identifier: NCT03214367; PRONTO-T2D ClinicalTrials.gov Identifier: NCT03214380.
MeSH term(s)	Humans ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 1/drug therapy ; Glycated Hemoglobin ; Blood Glucose ; Hypoglycemic Agents/therapeutic use ; Blood Glucose Self-Monitoring/methods ; Insulin/therapeutic use ; Glucose ; Fasting
Chemical Substances	Glycated Hemoglobin ; Blood Glucose ; Hypoglycemic Agents ; Insulin ; Glucose (IY9XDZ35W2)
Language	English
Publishing date	2023-11-16
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1105840-7
ISSN	1873-460X ; 1056-8727
ISSN (online)	1873-460X
ISSN	1056-8727
DOI	10.1016/j.jdiacomp.2023.108648
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Zs.A 2225: Show issues

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bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
Jg. 1995 - 2021: Lesesall (1.OG)
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Article ; Online: Randomized Double-Blind Clinical Trial Comparing Ultra Rapid Lispro With Lispro in a Basal-Bolus Regimen in Patients With Type 2 Diabetes: PRONTO-T2D.

Blevins, Thomas / Zhang, Qianyi / Frias, Juan P / Jinnouchi, Hideaki / Chang, Annette M

Diabetes care

2020 Volume 43, Issue 12, Page(s) 2991–2998

Abstract: Objective: To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in patients with type 2 diabetes on a basal-bolus insulin regimen.: Research design and methods: This was a phase 3, treat-to-target, double-blind 26-week study. ...

Abstract	Objective: To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in patients with type 2 diabetes on a basal-bolus insulin regimen. Research design and methods: This was a phase 3, treat-to-target, double-blind 26-week study. After an 8-week lead-in to optimize basal insulin glargine or degludec in combination with prandial lispro treatment, patients were randomized to blinded URLi ( Results: HbA Conclusions: URLi compared with lispro in a basal-bolus regimen was confirmed to be noninferior for HbA
MeSH term(s)	Aged ; Blood Glucose/drug effects ; Blood Glucose/metabolism ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/epidemiology ; Diabetes Mellitus, Type 2/metabolism ; Double-Blind Method ; Drug Therapy, Combination ; Equivalence Trials as Topic ; Female ; Glycated Hemoglobin/analysis ; Glycated Hemoglobin/drug effects ; Humans ; Hypoglycemia/chemically induced ; Hypoglycemia/epidemiology ; Hypoglycemic Agents/administration & dosage ; Hypoglycemic Agents/adverse effects ; Insulin Glargine/administration & dosage ; Insulin Glargine/adverse effects ; Insulin Lispro/administration & dosage ; Insulin Lispro/adverse effects ; Insulin, Long-Acting/administration & dosage ; Insulin, Long-Acting/adverse effects ; Male ; Meals ; Metformin/administration & dosage ; Metformin/adverse effects ; Middle Aged ; Postprandial Period/drug effects ; Sodium-Glucose Transporter 2 Inhibitors/administration & dosage ; Sodium-Glucose Transporter 2 Inhibitors/adverse effects ; Treatment Outcome
Chemical Substances	Blood Glucose ; Glycated Hemoglobin A ; Hypoglycemic Agents ; Insulin Lispro ; Insulin, Long-Acting ; Sodium-Glucose Transporter 2 Inhibitors ; Insulin Glargine (2ZM8CX04RZ) ; insulin degludec (54Q18076QB) ; Metformin (9100L32L2N)
Language	English
Publishing date	2020-07-02
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	441231-x
ISSN	1935-5548 ; 0149-5992
ISSN (online)	1935-5548
ISSN	0149-5992
DOI	10.2337/dc19-2550
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Zs.A 1434: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 365: Show issues

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Article ; Online: Time-Averaged Self-Monitored Blood Glucose Values Estimate Hemoglobin A1c Outcomes in Patients With Type 1 Diabetes.

Zhang, Shuyu / Fan, Ludi / Zhang, Qianyi / Chang, Annette M / Bastyr, Edward J / Harris, Cynthia J

Journal of diabetes science and technology

2018 Volume 12, Issue 4, Page(s) 905–906

MeSH term(s)	Blood Glucose/analysis ; Blood Glucose Self-Monitoring/methods ; Diabetes Mellitus, Type 1/blood ; Female ; Glycated Hemoglobin/analysis ; Humans ; Male ; Middle Aged
Chemical Substances	Blood Glucose ; Glycated Hemoglobin A ; hemoglobin A1c protein, human
Language	English
Publishing date	2018-03-07
Publishing country	United States
Document type	Letter ; Research Support, Non-U.S. Gov't
ISSN	1932-2968
ISSN (online)	1932-2968
DOI	10.1177/1932296818761963
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Article ; Online: Dose Unit Establishment for a New Basal Insulin Using Joint Modeling of Insulin Dose and Glycemic Response.

Qu, Yongming / Luo, Junxiang / Garhyan, Parag / Antalis, Caryl J / Chang, Annette M / Jacober, Scott J

Journal of diabetes science and technology

2017 Volume 12, Issue 1, Page(s) 155–162

Abstract: Background: For new insulin analogs with properties that vary from human insulin, defining activity in units of human insulin based on glycemic lowering efficacy may be challenging. Here we present a new method that can be used to quantify a unit dose ... ...

Abstract	Background: For new insulin analogs with properties that vary from human insulin, defining activity in units of human insulin based on glycemic lowering efficacy may be challenging. Here we present a new method that can be used to quantify a unit dose of an experimental insulin when the traditional euglycemic clamp method is not adequate. Methods: Joint modeling of insulin dose and the glycemic outcome variable hemoglobin A1c (HbA1c), where both were response variables, was used to evaluate insulin unit potency for basal insulin peglispro (BIL). The data were from the Phase 3 program for BIL, which included greater than 5500 patients with type 1 or type 2 diabetes who were treated for 26 or 52 weeks with BIL or a comparator insulin. Both basal-bolus and basal insulin only studies were included, and some type 2 diabetes patients were insulin-naïve. Results: The analysis showed that 1 unit of BIL, composed of 9 nmol of active ingredient, had similar or slightly greater potency compared to 1 unit insulin glargine or NPH insulin for all populations. Conclusions: Despite some limitations, the joint modeling of HbA1c and insulin dose provides a reasonable approach to estimate the relative potency of a new basal insulin versus an established basal insulin.
MeSH term(s)	Blood Glucose/analysis ; Diabetes Mellitus, Type 1/blood ; Diabetes Mellitus, Type 1/drug therapy ; Diabetes Mellitus, Type 2/blood ; Diabetes Mellitus, Type 2/drug therapy ; Glycated Hemoglobin A/analysis ; Humans ; Hypoglycemic Agents/administration & dosage ; Hypoglycemic Agents/therapeutic use ; Insulin/administration & dosage ; Insulin/therapeutic use ; Models, Theoretical ; Treatment Outcome
Chemical Substances	Blood Glucose ; Glycated Hemoglobin A ; Hypoglycemic Agents ; Insulin ; hemoglobin A1c protein, human
Language	English
Publishing date	2017-05-03
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ISSN	1932-2968
ISSN (online)	1932-2968
DOI	10.1177/1932296817707542
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Article ; Online: Relationship of Glucose Variability With Glycated Hemoglobin and Daily Mean Glucose: A Post Hoc Analysis of Data From 5 Phase 3 Studies.

Luo, Junxiang / Qu, Yongming / Zhang, Qianyi / Chang, Annette M / Jacober, Scott J

Journal of diabetes science and technology

2017 Volume 12, Issue 2, Page(s) 325–332

Abstract: Background: The association of glucose variability (GV) with other glycemic measures is emerging as a topic of interest. The aim of this analysis is to study the correlation between GV and measures of glycemic control, such as glycated hemoglobin (HbA1c) ...

Abstract	Background: The association of glucose variability (GV) with other glycemic measures is emerging as a topic of interest. The aim of this analysis is to study the correlation between GV and measures of glycemic control, such as glycated hemoglobin (HbA1c) and daily mean glucose (DMG). Methods: Data from 5 phase 3 trials were pooled into 3 analysis groups: type 2 diabetes (T2D) treated with basal insulin only, T2D treated with basal-bolus therapy, and type 1 diabetes (T1D). A generalized boosted model was used post hoc to assess the relationship of the following variables with glycemic control parameters (HbA1c and DMG): within-day GV, between-day GV (calculated using self-monitored blood glucose and fasting blood glucose [FBG]), hypoglycemia rate, and certain baseline characteristics. Results: Within-day GV (calculated using standard deviation [SD]) was found to have a significant influence on endpoints HbA1c and DMG in all 3 patient groups. Between-day GV from FBG (calculated using SD), within-day GV (calculated using coefficient of variation), and hypoglycemia rate were found to significantly influence the endpoint HbA1c in the T2D basal-only group. Conclusions: Lower within-day GV was significantly associated with improvement in DMG and HbA1c. This finding suggests that GV could be a marker in the early phases of new antihyperglycemic therapy development for predicting clinical outcomes in terms of HbA1c and DMG.
MeSH term(s)	Blood Glucose ; Clinical Trials, Phase III as Topic ; Diabetes Mellitus, Type 1/blood ; Diabetes Mellitus, Type 1/drug therapy ; Diabetes Mellitus, Type 2/blood ; Diabetes Mellitus, Type 2/drug therapy ; Glycated Hemoglobin A ; Humans ; Hypoglycemic Agents/therapeutic use ; Insulin/therapeutic use ; Retrospective Studies
Chemical Substances	Blood Glucose ; Glycated Hemoglobin A ; Hypoglycemic Agents ; Insulin
Language	English
Publishing date	2017-10-23
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	1932-2968
ISSN (online)	1932-2968
DOI	10.1177/1932296817736315
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Article: Short-term exercise improves beta-cell function and insulin resistance in older people with impaired glucose tolerance.

Bloem, Cathie J / Chang, Annette M

The Journal of clinical endocrinology and metabolism

2007 Volume 93, Issue 2, Page(s) 387–392

Abstract: Background: There is a high prevalence of diabetes and impaired glucose tolerance (IGT) in the older population. Normal aging is associated with insulin resistance and impaired insulin secretion, with greater defects in people with IGT. Short-term ... ...

Abstract	Background: There is a high prevalence of diabetes and impaired glucose tolerance (IGT) in the older population. Normal aging is associated with insulin resistance and impaired insulin secretion, with greater defects in people with IGT. Short-term exercise has been found to increase insulin sensitivity, but little is known about acute exercise effects on beta-cell function in older people with IGT. Methods: We assessed the effects of 7 consecutive days of supervised aerobic exercise (1 h/d at 60-70% heart rate reserve) in 12 sedentary older people with IGT. Screening included oral glucose tolerance test, stress/maximal O(2) uptake test, and dual-energy x-ray absorptiometry scan. Participants had a frequently sampled iv glucose tolerance test at baseline and 15-20 h after the seventh exercise session. Insulin sensitivity (S(I)), glucose disappearance constant (Kg, a measure of iv glucose tolerance), acute insulin response to glucose (AIRg), and disposition index (AIRg x S(I)), a measure of beta-cell function in relation to insulin resistance, were calculated. Results: Exercise was well tolerated. Body weight, fasting glucose, fasting insulin, and iv glucose tolerance were unchanged with exercise. S(I) increased by 59%, AIRg decreased by 12%, and disposition index increased by 31%. There was no significant change in fasting lipid, catecholamine, leptin, or adiponectin levels. Conclusions: Short-term exercise not only improved insulin resistance but also significantly enhanced beta-cell function in older people with IGT. These effects of short-term exercise on beta-cell function cannot be explained by changes in body weight or circulating levels of lipids, leptin, adiponectin, or catecholamines.
MeSH term(s)	Adiponectin/blood ; Aged ; Blood Glucose/metabolism ; Body Weight/physiology ; Catecholamines/blood ; Exercise/physiology ; Fatty Acids, Nonesterified/blood ; Female ; Glucose Tolerance Test ; Humans ; Insulin/blood ; Insulin Resistance/physiology ; Insulin-Secreting Cells/physiology ; Leptin/blood ; Male ; Oxygen Consumption/physiology ; Triglycerides/blood
Chemical Substances	ADIPOQ protein, human ; Adiponectin ; Blood Glucose ; Catecholamines ; Fatty Acids, Nonesterified ; Insulin ; Leptin ; Triglycerides
Language	English
Publishing date	2007-11-13
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	3029-6
ISSN	1945-7197 ; 0021-972X
ISSN (online)	1945-7197
ISSN	0021-972X
DOI	10.1210/jc.2007-1734
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Uh III Zs.134: Show issues

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Article ; Online: Performance of an Electronic Diary System for Intensive Insulin Management in Global Diabetes Clinical Trials.

Bastyr, Edward J / Zhang, Shuyu / Mou, Jiani / Hackett, Andy P / Raymond, Stephen A / Chang, Annette M

Diabetes technology & therapeutics

2015 Volume 17, Issue 8, Page(s) 571–579

Abstract: Background: This report describes the performance of a wireless electronic diary (e-diary) system for data collection and enhanced patient-investigator interactions during intensive insulin management in diabetes clinical trials.: Materials and ... ...

Abstract	Background: This report describes the performance of a wireless electronic diary (e-diary) system for data collection and enhanced patient-investigator interactions during intensive insulin management in diabetes clinical trials. Materials and methods: We implemented a customized electronic communication system featuring an e-diary and a Web portal in three global, randomized, controlled Phase 3 clinical trials testing basal insulin peglispro compared with insulin glargine, both combined with prandial insulin lispro, in patients with type 1 or type 2 diabetes mellitus (T1DM and T2DM, respectively). We collected data during 28 weeks of study e-diary use for the report. Results: Patients (n=2,938) in 31 countries used e-diaries to transmit 2,439,087 blood glucose (BG) values, 96% of which were associated by the patient with a protocol time point during the 72-h response window. Of 208,192 hypoglycemia events captured, 96% had a BG value, and 95% had treatments and outcomes entered by patients within the 72-h window. Patients recorded administration of 1,964,477 insulin doses; 93% of basal insulin doses were adherent with the investigator prescription. Investigators adjusted 13 basal and 92 bolus insulin prescriptions per patient-year using the e-diary system. After 26 weeks of treatment and e-diary use in the combined study arms, hemoglobin A1c values decreased by 0.6% or 1.6% and fasting BG decreased by 7.8 or 28 mg/dL in patients with T1DM or T2DM, respectively. Conclusions: The e-diary system enabled comprehensive data collection and facilitated communication between investigators and patients for intensive insulin management in three global clinical trials testing basal insulins.
MeSH term(s)	Adult ; Aged ; Blood Glucose/analysis ; Blood Glucose Self-Monitoring/instrumentation ; Blood Glucose Self-Monitoring/methods ; Diabetes Mellitus/blood ; Diabetes Mellitus/drug therapy ; Electronic Prescribing/statistics & numerical data ; Fasting/blood ; Female ; Glycated Hemoglobin A/analysis ; Humans ; Hypoglycemic Agents/administration & dosage ; Insulin Glargine/administration & dosage ; Insulin Lispro/administration & dosage ; Insulin, Long-Acting/administration & dosage ; Male ; Middle Aged ; Randomized Controlled Trials as Topic/instrumentation ; Telemetry/instrumentation ; Telemetry/methods ; Time Factors
Chemical Substances	Blood Glucose ; Glycated Hemoglobin A ; Hypoglycemic Agents ; Insulin Lispro ; Insulin, Long-Acting ; hemoglobin A1c protein, human ; Insulin Glargine (2ZM8CX04RZ)
Language	English
Publishing date	2015-08
Publishing country	United States
Document type	Evaluation Studies ; Journal Article
ZDB-ID	1452816-2
ISSN	1557-8593 ; 1520-9156
ISSN (online)	1557-8593
ISSN	1520-9156
DOI	10.1089/dia.2014.0407
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