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nocturnal hypoglycemia

Fumitaka Okajima, Tomoko Nagamine, Yuko Nakamura, Naomi Hattori, Hitoshi Sugihara, Naoya Emoto
The efficacy of the administration of sodium-glucose co-transporter 2 inhibitor (SGLT2I) or the co-administration of SGLT2I and dipeptidyl peptidase-4 inhibitor (DPP-4I) to insulin therapy is not well known. Fifty-eight patients with type 2 diabetes, admitted for glycemic control, were randomized to basal-bolus insulin therapy (BBT) alone or BBT plus 50 mg ipragliflozin and/or 20 mg teneligliptin. Insulin doses were adjusted to maintain normal blood glucose levels. Plasma glucose profiles were estimated by continuous glucose monitoring (CGM) before discharge...
October 20, 2016: Journal of Diabetes Investigation
Ajay Kumar, Edward Franek, Jonathan Wise, Marcus Niemeyer, Henriette Mersebach, Rafael Simó
PURPOSE: The efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily (OD) compared with insulin glargine U100 (IGlar) OD over 52 weeks in insulin-naïve adults with type 2 diabetes mellitus (T2DM) was investigated. METHODS: In this open-label, parallel-group treat-to-target trial, participants were randomized (1:1) to receive IDegAsp OD (breakfast, n = 266) or IGlar OD (as per label, n = 264). Participants then entered a 26-week extension phase (IDegAsp OD, n = 192; IGlar OD, n = 221)...
2016: PloS One
Soichi Takeishi, Akihiro Mori, Miyuka Kawai, Yohei Yoshida, Hiroki Hachiya, Takayuki Yumura, Shun Ito, Takashi Shibuya, Nobutoshi Fushimi, Noritsugu Ohashi, Hiromi Kawai
Objective The aim of this study was to determine whether nocturnal hypoglycemia may be predicted according to morning glucose levels. Methods We retrospectively evaluated 106 patients with type 2 diabetes who underwent continuous glucose monitoring during admission. The pre-breakfast glucose level (Pre-breakfast level), highest postprandial glucose level within 3 hours after breakfast (Highest level), time from the start of breakfast to the highest postprandial glucose level (Highest time), difference between the pre-breakfast and highest postprandial breakfast glucose levels (Increase), area under the glucose curve (≥180 mg/dL) within 3 hours after breakfast (Morning AUC), post-breakfast glucose gradient (Gradient), and the increase-to-pre-breakfast ratio (Increase/Pre-breakfast) were calculated...
2016: Internal Medicine
Tatsuhiko Urakami, Yusuke Mine, Masako Aoki, Misako Okuno, Junichi Suzuki
This study implemented a randomized crossover design to evaluate the efficacy and safety of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in 18 children (11 males, 7 females; age 11.0 ± 0.5 years) with type 1 diabetes. All subjects had previously used IGlar once daily at bedtime. We compared fasting plasma glucose (FPG) and HbA1c levels, frequencies of overall and nocturnal (2200 h - 0659 h) hypoglycemia, and basal insulin dose at the baseline with those measured during a 24-week period during which IGlar or IDeg was administered in combination with pre-meal rapid acting insulin analogues...
October 14, 2016: Endocrine Journal
Jennifer N Clements, Tiffaney Threatt, Eileen Ward, Kayce M Shealy
Concentrated insulin analogs have recently been approved and are available for clinical use in the management of diabetes mellitus. One new product is insulin glargine U-300 (Sanofi), a basal concentrated insulin of 300 U/mL. Several studies have been conducted and completed evaluating blood samples for the pharmacokinetics of insulin glargine U-300 and euglycemic clamp procedures for the pharmacodynamics. This concentrated insulin has a low within-day variability and high day-to-day reproducibility, allowing for a more constant and prolonged duration of action, compared with insulin glargine U-100 (100 U/mL)...
October 4, 2016: Clinical Pharmacokinetics
Gerry Oster, Sean D Sullivan, Mehul R Dalal, Mahmood R Kazemi, Maria Rojeski, Carol H Wysham, Jennifer Sung, Bryan Johnstone, Anna M G Cali, L J Wei, Louise Traylor, Henry Anhalt, Michelle Hull, John Van Vleet, Luigi F Meneghini
OBJECTIVE: This study aims to compare the effectiveness of insulin glargine 300 U/mL (Gla-300) with its accompanying patient support program with that of other basal insulin and available patient support programs in patients with type 2 diabetes (T2D) in a real-world setting in terms of achieving HEDIS (Healthcare Effectiveness Data and Information Set) individualized glycemic targets without documented symptomatic hypoglycemia. STUDY DESIGN AND METHODS: Achieve Control is a US-based, multicenter, randomized, open-label, active-controlled, parallel group pragmatic Phase IV trial in insulin-naïve patients with T2D uncontrolled on ≥2 oral antidiabetes drugs (OAD) and/or glucagon-like peptide-1 receptor antagonists (GLP-1 RA)...
October 3, 2016: Postgraduate Medicine
Giesje Nefs, François Pouwer, Richard I G Holt, Søren Skovlund, Norbert Hermanns, Antonio Nicolucci, Mark Peyrot
OBJECTIVE: We examined (a) the demographic and clinical correlates of worries about hypoglycemia in adult family members of adults with diabetes, and (b) the association of these worries with measures of diabetes support. METHODS: The second multinational Diabetes Attitudes, Wishes and Needs (DAWN2) study cross-sectionally surveyed 2057 family members from 17 countries. Participants completed questions about demographics, diabetes, and psychosocial functioning, including worry about overall and nocturnal hypoglycemia...
October 2016: Journal of Psychosomatic Research
Sivananthan Sampath, Pavlo Tkachenko, Eric Renard, Sergei V Pereverzev
BACKGROUND: Despite the risk associated with nocturnal hypoglycemia (NH) there are only a few methods aiming at the prediction of such events based on intermittent blood glucose monitoring data. One of the first methods that potentially can be used for NH prediction is based on the low blood glucose index (LBGI) and suggested, for example, in Accu-Chek® Connect as a hypoglycemia risk indicator. On the other hand, nowadays there are other glucose control indices (GCI), which could be used for NH prediction in the same spirit as LBGI...
September 22, 2016: Journal of Diabetes Science and Technology
Vadim V Klimontov, Natalia E Myakina
AIM: O determine the applicability of glucose variability (GV) indices derived from continuous glucose monitoring (CGM) data for prediction of nocturnal hypoglycemia (NH) in elderly patients with type 2 diabetes treated with insulin. METHODS: We observed 83 insulin-treated in-patients, 65-80 years of age. Blinded CGM data for 176 nights were analyzed. Daytime (06:00-22:59) mean glucose, Standard Deviation (SD), 2-h Continuous Overlapping Net Glycemic Action (CONGA2) and Mean Absolute Glucose (MAG), pre-midnight (23:00-23:59) mean glucose, SD and MAG, 24-h Mean Amplitude of Glucose Excursions (MAGE), were estimated...
August 23, 2016: Diabetes & Metabolic Syndrome
Yukiko Onishi, Kenichi Yamada, Jeppe Zacho, Jan Ekelund, Yasuhiko Iwamoto
AIMS/INTRODUCTION: Insulin degludec/insulin aspart (IDegAsp) is a soluble combination of insulin degludec (70%) and insulin aspart (30%). The present exploratory trial investigated the safety of switching unit-to-unit from twice-daily basal or pre-mix insulin to twice-daily IDegAsp in Japanese patients with type 2 diabetes. MATERIALS AND METHODS: In this 6-week, open-label, parallel-group, controlled trial, 66 participants were randomized (1:1) to receive either IDegAsp or biphasic insulin aspart 30 (BIAsp 30) twice daily at the same total daily dose as pre-trial insulin...
August 25, 2016: Journal of Diabetes Investigation
Avital Adler, Michal-Yackobovitz Gavan, Riva Tauman, Moshe Phillip, Shlomit Shalitin
BACKGROUND: Sleep has been shown to impact glucose regulation, and may be altered in persons with type 1 diabetes (T1D). OBJECTIVE: To assess sleep characteristics in T1D patients and the possible association between sleep disturbances and diabetes-related variables. SUBJECTS AND METHODS: In a cross-sectional study in 154 young patients with T1D and 154 age-range-matched nondiabetic controls subjective sleep characteristics were assessed using validated questionnaires: Sleep Disturbance Scale for Children (SDSC), Adolescent Sleep-Wake Scale (ASWS), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS)...
August 3, 2016: Pediatric Diabetes
Julio Rosenstock, Michel Marre, Yongming Qu, Shuyu Zhang, Edward J Bastyr, Melvin J Prince, Annette M Chang
Basal insulin peglispro (BIL) is a novel basal insulin with hepato-preferential action, resulting from reduced peripheral effects. This report summarizes hypoglycaemia data from five BIL phase III studies with insulin glargine as the comparator, including three double-blind trials. Prespecified pooled analyses (n = 4927) included: patients with type 2 diabetes (T2D) receiving basal insulin only, those with T2D on basal-bolus therapy, and those with type 1 diabetes (T1D). BIL treatment resulted in a 36-45% lower nocturnal hypoglycaemia rate compared with glargine, despite greater reduction in glycated haemoglobin (HbA1c) and higher basal insulin dosing...
November 2016: Diabetes, Obesity & Metabolism
Daisuke Tsujino, Rimei Nishimura, Yoshiko Onda, Chiaki Seo, Kiyotaka Ando, Aya Morimoto, Kazunori Utsunomiya
BACKGROUND: We aimed to examine the relationship between the occurrence of hypo-/hyperglycemia and HbA1c values, as assessed by continuous glucose monitoring (CGM) in patients with type 1 diabetes. METHODS: The study subjects comprised 101 type 1 diabetic patients on basal-bolus insulin therapy, who were put on masked CGM immediately after admission. The subjects were divided into four groups equally by HbA1c values and the 24-h CGM data were compared among the groups...
2016: Diabetology & Metabolic Syndrome
Khalid Benkhadra, Fares Alahdab, Shrikant U Tamhane, Rozalina G McCoy, Larry J Prokop, Mohammad Hassan Murad
The relative efficacy of continuous subcutaneous insulin infusion and multiple daily injections in individuals with type 1 diabetes is unclear. We sought to synthesize the existing evidence about the effect of continuous subcutaneous insulin infusion on glycosylated hemoglobin, hypoglycemic events, and time spent in hypoglycemia compared to multiple daily injections. We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and Database of Systematic Reviews, and Scopus from January 2008 through November 2015 for randomized controlled trials that enrolled children or adults with type 1 diabetes...
August 1, 2016: Endocrine
David R Owens
INTRODUCTION: A more concentrated insulin glargine formulation, containing 300 U/mL (Gla-300) was approved in 2015 in the US and Europe for the treatment of diabetes mellitus in adults. AREAS COVERED: This drug evaluation focuses on the pharmacokinetics (PK) and pharmacodynamics (PD) of Gla-300 from studies published up to May 2016. The clinical relevance of this new formulation will be addressed. EXPERT OPINION: Gla-300 was developed to produce a flatter and more prolonged PK/PD profile compared with insulin glargine 100 U/mL (Gla-100) in order to maintain effective glycemic control and reduce the risk of hypoglycemia...
August 2016: Expert Opinion on Drug Metabolism & Toxicology
(no author information available yet)
This article will be part of a supplement and will be republished when the entire issue is complete.
July 8, 2016: Diabetes, Obesity & Metabolism
Robert Powell, Matthew Corcoran
No abstract text is available yet for this article.
May 2016: Medicine and Science in Sports and Exercise
M J Davies, D Russell-Jones, J-L Selam, T S Bailey, Z Kerényi, J Luo, J Bue-Valleskey, T Iványi, M L Hartman, J G Jacobson, S J Jacober
AIMS: Basal insulin peglispro is a long-acting insulin analog with hepato-preferential action. This double-blind, randomized, multi-national study compared 52- or 78-week treatment with basal insulin peglispro or insulin glargine, added to pre-study oral antihyperglycemic medications, in insulin-naïve adults with type 2 diabetes. MATERIAL AND METHODS: Primary outcome was noninferiority of peglispro to glargine in HbA1c reduction (margin=0.4%). Six gated secondary objectives with statistical multiplicity adjustments assessed other measures of glycemic control...
June 28, 2016: Diabetes, Obesity & Metabolism
Maja Baretić, Ivana Kraljević, Ivana Pavlić Renar
The aim was to determine which adult type 1 diabetic patient receiving multiple daily injection therapy is the most appropriate candidate for insulin pump therapy, while taking into consideration limited insulin pump affordability in Croatia. A total of 145 type 1 diabetic patients (52% diagnosed in adult age) were monitored at the Department of Endocrinology, Clinical Department of Internal Medicine, Zagreb University Hospital Center from 2009 to 2014. Twenty-one patients started insulin pump therapy in adulthood (seven men and 14 women, median age 27)...
March 2016: Acta Clinica Croatica
Richard M Bergenstal, Helen Lunt, Edward Franek, Florence Travert, Jiani Mou, Yongming Qu, Caryl J Antalis, Mark L Hartman, Myriam Rosilio, Scott J Jacober, Edward J Bastyr
AIMS: To compare the efficacy and safety of basal insulin peglispro (BIL), with a flat pharmacokinetic and pharmacodynamic profile and a long duration of action, with insulin glargine (GL) in patients with type 1 diabetes. MATERIALS AND METHODS: In this Phase 3, 52-week, blinded study, we randomized 1114 adults with type 1 diabetes in a 3:2 distribution to receive either BIL (N = 664) or GL (N = 450) at bedtime, with preprandial insulin lispro, using intensive insulin management...
June 6, 2016: Diabetes, Obesity & Metabolism
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