A randomized trial to investigate the efficacy and safety of insulin glargine in hyperglycemic acute stroke patients receiving intensive care

AbstractThis pilot, randomized, open-label controlled study compared the basal–bolus regimens of insulin glargine (IG) and neutral protamine Hagedorn (NPH) insulin in stroke patients with hyperglycemia receiving intensive care. The study recruited acute stroke patients requiring intensive care within 72 h (h) of onset and had blood glucose > 200 mg/dL. 50 patients received IG (n = 26) or NPH (n = 24) with added short-acting prandial regular insulin over a 72-h period. The primary end point was the percentage of glucose within 80–180 mg/dL assessed through continuous glucose monitoring. The baseline characteristics were comparable, except the IG had higher glucose pre-randomization than the NPH (290.69 ± 82.31 vs. 246.04 ± 41.76 mg/dL, P = 0.021). The percentage of time with glucose between 80 and 180 mg/dL was 45.88 ± 27.04% in the IG and 53.56 ± 22.89% in the NPH (P = 0.341) and the percentage of glucose reduction was 31.47 ± 17.52% in the IG and 27.28 ± 14.56% in the NPH (P = 0.374). The percentage of time with glucose < 60 mg/dL was 0.14 ± 0.49% in the IG and 0.47 ± 1.74% in the NPH. Poststroke outcomes were not significantly different. In conclusion, IG is safe and equally effective as an NPH-based basal-bolus regimen for acute stroke patients with hyperglycemia receiving intensive care.Trial registration ClinicalTrials.gov, NCT02607943. Registered 18/11/2015, https://clinicaltrials.gov/ct2/show/NCT02607943.

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Efficacy and Safety of Insulin Glargine in Patients With Acute Stroke and Hyperglycemia Receiving Intensive Care: Randomized Controlled Study

10.21203/rs.3.rs-56284/v1 ◽

2020 ◽

Author(s):

Sung-Chun Tang ◽

Shyang-Rong Shih ◽

Shin-Yi Lin ◽

Chih-Hao Chen ◽

Shin-Joe Yeh ◽

...

Keyword(s):

Intensive Care ◽

Insulin Glargine ◽

Acute Stroke ◽

Controlled Study ◽

Efficacy And Safety ◽

Stroke Patients ◽

Glucose Levels ◽

Study Results ◽

Basal Bolus ◽

Glucose Reduction

Abstract Background: This pilot study compared the basal–bolus regimens of long-acting insulin glargine (IG) and neutral protamine Hagedorn (NPH) insulin in efficacy and safety in acute stroke patients with hyperglycemia receiving intensive care (NCT02607943).Methods: This was a randomized, open-label, clinical trial. Stroke patients who were admitted to the intensive care unit within 72 h of onset and met the inclusion criteria were enrolled. They received either IG or NPH with added short-acting prandial regular insulin over a 72-h period. The primary endpoints were the percentage of glucose within the range of 80 to 180 mg/dL and the percentage of glucose reduction compared with pre-randomization glucose levels, assessed through continuous glucose monitoring (CGM).Results: A total of 50 patients were included, 26 and 24 were randomly assigned to the IG and NPH, respectively. The participant baseline characteristics were comparable between groups, except the IG had a significantly higher glucose level pre-randomization than the NPH (290.69 ± 82.31 versus 246.04 ± 41.76 mg/dL, P = .021). CGM data showed that the percentage of time with glucose levels between 80 and 180 mg/dL was 45.88 ± 27.04% in the IG and 53.56 ± 22.89% in the NPH (P = .341) and the percentage of glucose reduction was 31.47 ± 17.52% in the IG and 27.28 ± 14.56% in the NPH (P = .374). The percentage of time with hypoglycemia (< 60 mg/dl) was 0.14 ± 0.49% in the IG and 0.47 ± 1.74% in the NPH (P = .361). Parameters representative of glucose variabilities, and poststroke outcomes were not significantly different between the groups.Conclusions: Our study results suggest that early initiation of an IG-based basal–bolus regimen is safe and equally effective as an NPH-based basal-bolus regimen for patients with acute stroke and hyperglycemia requiring intensive care.Trial registration: ClinicalTrials.gov, NCT02607943. Registered 18 Nov 2015, https://clinicaltrials.gov/ct2/show/NCT02607943

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Transcranial direct current stimulation associated with physical-therapy in acute stroke patients - A randomized, triple blind, sham-controlled study

Brain Stimulation ◽

10.1016/j.brs.2019.10.019 ◽

2020 ◽

Vol 13 (2) ◽

pp. 329-336 ◽

Cited By ~ 4

Author(s):

Stephen Bornheim ◽

Jean-Louis Croisier ◽

Pierre Maquet ◽

Jean-François Kaux

Keyword(s):

Physical Therapy ◽

Acute Stroke ◽

Direct Current ◽

Transcranial Direct Current Stimulation ◽

Controlled Study ◽

Stroke Patients ◽

Direct Current Stimulation

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Continuous glucose monitoring in acute stroke

Proceedings of the 8th International Workshop on Innovative Simulation for Healthcare (IWISH 2019) ◽

10.46354/i3m.2019.iwish.016 ◽

2019 ◽

Author(s):

Laura Aponte-Becerra ◽

Rodrigo Quispe ◽

Laura Mendez-Pino ◽

Vera Novak ◽

Magdy Selim ◽

...

Keyword(s):

Standard Deviation ◽

Acute Stroke ◽

Continuous Glucose Monitoring ◽

Poor Prognosis ◽

Glucose Monitoring ◽

Mean Amplitude ◽

P Value ◽

Stroke Patients ◽

Glycaemic Variability ◽

Acute Brain Ischemia

"Hyperglycaemia upon admission is a pathophysiological response to acute brain ischemia that has been independently associated with high mortality rate and poor prognosis. Glycaemic variability (GV) has also shown association with poor clinical outcomes among stroke patients. GV is best assessed by continuous glucose monitoring (CGM), which enables consecutives glucose measurements every 5 minutes. This pilot study aimed: 1) To describe safety, feasibility and tolerability of CGM in the acute stroke setting; and 2) To compare CGM and conventional FS glucose-based monitoring regimen in terms of their relationship with GUA and the accuracy of hypoglycaemic episodes detection. Safety, feasibility and tolerability of CGM was excellent in our cohort of 23 patients with acute stroke (61% ischemic and 39% intracerebral haemorrhage) and there were no adverse events. CGM recorded ten hypoglycaemic episodes that were not detected by conventional FS monitoring. GUA was associated with coefficient of variation (CV) of CGM (p=0.03), CV of FS (p=0.01), standard deviation (SD) of CGM (p-value=0.01) and mean amplitude of glucose excursions (MAGE) (pvalue= 0.001)."

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