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1.
Sleep Med Rev ; 76: 101951, 2024 May 07.
Article in English | MEDLINE | ID: mdl-38754209

ABSTRACT

Polysomnography (PSG) is the reference standard of sleep measurement, but is burdensome for the participant and labor intensive. Affordable electroencephalography (EEG)-based wearables are easy to use and are gaining popularity, yet selecting the most suitable device is a challenge for clinicians and researchers. In this systematic review, we aim to provide a comprehensive overview of available EEG-based wearables to measure human sleep. For each wearable, an overview will be provided regarding validated population and reported measurement properties. A systematic search was conducted in the databases OVID MEDLINE, Embase.com and CINAHL. A machine learning algorithm (ASReview) was utilized to screen titles and abstracts for eligibility. In total, 60 papers were selected, covering 34 unique EEG-based wearables. Feasibility studies indicated good tolerance, high compliance, and success rates. The 42 included validation studies were conducted across diverse populations and showed consistently high accuracy in sleep staging detection. Therefore, the recent advancements in EEG-based wearables show great promise as alternative for PSG and for at-home sleep monitoring. Users should consider factors like user-friendliness, comfort, and costs, as these devices vary in features and pricing, impacting their suitability for individual needs.

2.
Anaesthesia ; 78(5): 577-586, 2023 05.
Article in English | MEDLINE | ID: mdl-36632036

ABSTRACT

Postoperative neurocognitive disorders occur frequently in older adult patients. Neuropsychological assessment is the gold standard for diagnosis, but the resources required for routine use are significant. Instead, it is common for simplified and unvalidated tests to be used for trials and in clinical practice. We undertook a single-centre prospective observational study in elective surgical patients aged ≥ 65 years recruited between September 2019 and January 2021. Patients underwent neuropsychological assessment, the Modified Telephone Interview for Cognitive Status and Montreal Cognitive Assessment before surgery. Tests were repeated at approximately four to eight postoperative weeks. We included 105 patients and 28 (27%) were lost to follow-up. Pre-operative Modified Telephone Interview for Cognitive Status and cognitive domain scores were very weakly to moderately correlated (r = 0.09-0.41). Pre-operative Montreal Cognitive Assessment and cognitive domain scores were very weakly to weakly correlated (r = 0.17-0.37) Postoperative Modified Telephone Interview for Cognitive Status and cognitive domain scores were very weakly to weakly correlated (r = 0.09-0.36). Postoperative Montreal Cognitive Assessment score and cognitive domain scores were very weakly to weakly correlated (r = 0.07-0.36). Overall, there was limited agreement between tests. We conclude that the Modified Telephone Interview for Cognitive Status and Montreal Cognitive Assessment should not be used in isolation to diagnose postoperative neurocognitive disorders. There seems to be little to no pre-operative, postoperative or pre- to postoperative correlation between these tests and the neuropsychological assessment in older adults without pre-operative cognitive impairment.


Subject(s)
Cognitive Dysfunction , Humans , Aged , Cognitive Dysfunction/diagnosis , Neuropsychological Tests , Prospective Studies
3.
Anaesthesia ; 77(1): 73-81, 2022 01.
Article in English | MEDLINE | ID: mdl-34418064

ABSTRACT

Surgery and general anaesthesia have the potential to disturb the body's circadian timing system, which may affect postoperative outcomes. Animal studies suggest that anaesthesia could induce diurnal phase shifts, but clinical research is scarce. We hypothesised that surgery and general anaesthesia would result in peri-operative changes in diurnal sleep-wake patterns in patients. In this single-centre prospective cohort study, we recruited patients aged ≥18 years scheduled for elective surgery receiving ≥30 min of general anaesthesia. The Munich Chronotype Questionnaire and Pittsburgh Sleep Quality Index were used to determine baseline chronotype, sleep characteristics and sleep quality. Peri-operative sleeping patterns were logged. Ninety-four patients with a mean (SD) age of 52 (17) years were included; 56 (60%) were female. The midpoint of sleep (SD) three nights before surgery was 03.33 (55 min) and showed a phase advance of 40 minutes to 02.53 (67 min) the night after surgery (p < 0.001). This correlated with the midpoint of sleep three nights before surgery and was not associated with age, sex, duration of general anaesthesia or intra-operative dexamethasone use. Peri-operatively, patients had lower subjective sleep quality and worse sleep efficiency. Disruption started from one night before surgery and did not normalise until 6 days after surgery. We conclude that there is a peri-operative phase advance in midpoint of sleep, confirming our hypothesis that surgery and general anaesthesia disturb the circadian timing system. Patients had decreased subjective sleep quality, worse sleep efficiency and increased daytime fatigue.


Subject(s)
Anesthesia, General/methods , Circadian Clocks , Adult , Aged , Dexamethasone/administration & dosage , Elective Surgical Procedures , Female , Humans , Male , Middle Aged , Postoperative Period , Prospective Studies , Sleep Quality
4.
BMC Cancer ; 20(1): 142, 2020 Feb 22.
Article in English | MEDLINE | ID: mdl-32087686

ABSTRACT

BACKGROUND: Thoracic epidural analgesia is the standard postoperative pain management strategy in esophageal cancer surgery. However, paravertebral block analgesia may achieve comparable pain control while inducing less side effects, which may be beneficial for postoperative recovery. This study primarily aims to compare the postoperative quality of recovery between paravertebral catheter versus thoracic epidural analgesia in patients undergoing minimally invasive esophagectomy. METHODS: This study represents a randomized controlled superiority trial. A total of 192 patients will be randomized in 4 Dutch high-volume centers for esophageal cancer surgery. Patients are eligible for inclusion if they are at least 18 years old, able to provide written informed consent and complete questionnaires in Dutch, scheduled to undergo minimally invasive esophagectomy with two-field lymphadenectomy and an intrathoracic anastomosis, and have no contra-indications to either epidural or paravertebral analgesia. The primary outcome is the quality of postoperative recovery, as measured by the Quality of Recovery-40 (QoR-40) questionnaire on the morning of postoperative day 3. Secondary outcomes include the QoR-40 questionnaire score Area Under the Curve on postoperative days 1-3, the integrated pain and systemic opioid score and patient satisfaction and pain experience according to the International Pain Outcomes (IPO) questionnaire, and cost-effectiveness. Furthermore, the groups will be compared regarding the need for additional rescue medication on postoperative days 0-3, technical failure of the pain treatment, duration of anesthesia, duration of surgery, total postoperative fluid administration day 0-3, postoperative vasopressor and inotrope use, length of urinary catheter use, length of hospital stay, postoperative complications, chronic pain at six months after surgery, and other adverse effects. DISCUSSION: In this study, it is hypothesized that paravertebral analgesia achieves comparable pain control while causing less side-effects such as hypotension when compared to epidural analgesia, leading to shorter postoperative length of stay on a monitored ward and superior quality of recovery. If this hypothesis is confirmed, the results of this study can be used to update the relevant guidelines on postoperative pain management for patients undergoing minimally invasive esophagectomy. TRIAL REGISTRATION: Netherlands Trial Registry, NL8037. Registered 19 September 2019.


Subject(s)
Analgesia, Epidural/methods , Catheterization/methods , Esophageal Neoplasms/surgery , Esophagectomy/adverse effects , Minimally Invasive Surgical Procedures/adverse effects , Pain Management/methods , Pain, Postoperative/prevention & control , Adolescent , Adult , Aged , Aged, 80 and over , Analgesics, Opioid/administration & dosage , Esophageal Neoplasms/pathology , Female , Humans , Length of Stay/statistics & numerical data , Male , Middle Aged , Nerve Block/methods , Netherlands , Pain Measurement/methods , Pain, Postoperative/etiology , Pain, Postoperative/pathology , Postoperative Period , Treatment Outcome , Young Adult
5.
Expert Opin Drug Saf ; 18(7): 591-601, 2019 07.
Article in English | MEDLINE | ID: mdl-31107108

ABSTRACT

INTRODUCTION: Epidural analgesia is a popular approach to postoperative and labor pain. Neurotoxicity and drug-specific systemic side effects can occur after epidural administration. As an increasing number of epidural drugs are studied and clinically applied, drug efficacy and safety evaluation are crucial. AREAS COVERED: In this narrative review, the authors provide a thorough overview on the safety of the most widely used epidural drugs, focusing on potential neurotoxicity, side effects, and complications in the adult, non-pregnant population. A combined text and MeSH heading search strategy was used to identify relevant publications. EXPERT OPINION: The search for the ideal epidural medication has resulted in a surplus of drug combinations with extensive heterogeneity amongst studies, while the value of investigating these is not always evident. Epidural drugs pose a potential threat of neurotoxicity and other side effects. Consequently, we should pursue safe epidural drug administration to patients and refrain from drugs with minimal proven benefit. Also, studies should compare epidural with systemic application. Because why use a drug epidurally, which can be safely used systemically? Future research should focus on providing solid evidence regarding efficacy of epidural analgesia compared to new and already existing modalities and optimizing presently used medicinal regimens.


Subject(s)
Analgesia, Epidural/methods , Labor Pain/drug therapy , Pain, Postoperative/drug therapy , Adult , Analgesia, Epidural/adverse effects , Analgesics/administration & dosage , Analgesics/adverse effects , Female , Humans , Neurotoxicity Syndromes/etiology , Pregnancy
6.
Anaesthesia ; 74(7): 929-939, 2019 Jul.
Article in English | MEDLINE | ID: mdl-30821852

ABSTRACT

In the peri-operative period, dexamethasone is widely and effectively used for prophylaxis of postoperative nausea and vomiting. The objective of this meta-analysis was to assess the adverse effects of an incidental steroid load of dexamethasone in adult surgical patients. We searched in MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and the Web of Science for randomised controlled trials comparing an incidental steroid load of dexamethasone with a control intervention in adult patients undergoing surgery. Two review authors independently screened studies for eligibility, extracted data and assessed all included studies for bias. Our primary outcomes were postoperative systemic or wound infection, delayed wound healing and glycaemic response within 24 h. We included 37 studies in this meta-analysis. The pooled results found no evidence that dexamethasone increased the risk of a postoperative wound infection, Peto OR (95%CI) 1.01 (0.80-1.27); 4603 participants, 26 studies; I² = 32%; moderate-quality evidence. Whether dexamethasone influenced wound healing was unclear due to the large confidence intervals, Peto OR (95%CI) 0.99 (0.28-3.43); 1072 participants, 8 studies; I² = 0%; low-quality evidence. Dexamethasone produced a mild increase in glucose levels among participants without diabetes during the first 12 h after surgery, mean difference (95%CI) 0.7 mmol.l-1 (0.3-1.2) 10 studies; 595 participants; I² = 50%; low-quality evidence. This article is an abridged version of a Cochrane Review.


Subject(s)
Dexamethasone/adverse effects , Glucocorticoids/adverse effects , Postoperative Complications/chemically induced , Humans
7.
Br J Anaesth ; 121(6): 1298-1307, 2018 Dec.
Article in English | MEDLINE | ID: mdl-30442257

ABSTRACT

BACKGROUND: The baroreflex regulates arterial blood pressure (BP). During periods when blood pressure changes, cerebral blood flow (CBF) is kept constant by cerebral autoregulation (CA). In patients with diabetes mellitus (DM), low baroreflex sensitivity (BRS) is associated with impaired CA. As sevoflurane-based anaesthesia obliterates BRS, we hypothesised that this could aggravate the already impaired CA in patients with DM resulting in a 'double-hit' on cerebral perfusion leading to increased fluctuations in blood pressure and cerebral perfusion. METHODS: On the day before surgery, we measured CBF velocity (CBFV), heart rate, and BP to determine BRS and CA efficacy (CBFVmean-to-BPmean-phase lead) in 25 patients with DM and in 14 controls. During the operation, BRS and CA efficacy were determined during sevoflurane-based anaesthesia. Patients with DM were divided into a group with high BRS (DMBRS↑) and a group with low BRS (DMBRS↓). Values presented are median (inter-quartile range). RESULTS: Preoperative vs intraoperative BRS was 6.2 (4.5-8.5) vs 1.9 (1.1-2.5, P<0.001) ms mm Hg-1 for controls, 5.8 (4.9-7.6) vs 2.7 (1.5-3.9, P<0.001) ms mm Hg-1 for patients with DMBRS↑, and 1.9 (1.5-2.8) vs 1.1 (0.6-2.5, P=0.31) ms mm Hg-1 for patients with DMBRS↓. Preoperative vs intraoperative CA efficacy was 43° (38-46) vs 43° (38-51, P=0.30), 44° (36-49) vs 41° (32-49, P=0.52), and 34° (28-40) vs 30° (27-38, P=0.64) for controls, DMBRS↑, and DMBRS↓ patients, respectively. CONCLUSIONS: In diabetic patients with low preoperative BRS, preoperative CA efficacy was also impaired. In controls and diabetic patients, CA was unaffected by sevoflurane-based anaesthesia. We therefore conclude that sevoflurane-based anaesthesia does not contribute to a 'double-hit' phenomenon on cerebral perfusion. CLINICAL TRIAL REGISTRATION: NCT 03071432.


Subject(s)
Anesthesia, Inhalation , Cerebrovascular Circulation/physiology , Diabetes Mellitus, Type 2/physiopathology , Homeostasis/physiology , Sevoflurane/pharmacology , Adult , Aged , Aged, 80 and over , Baroreflex/physiology , Female , Hemodynamics , Humans , Male , Middle Aged
8.
Diabetes Obes Metab ; 20(3): 749-752, 2018 03.
Article in English | MEDLINE | ID: mdl-28940961

ABSTRACT

Historically, metformin was withheld before surgery for fear of metformin-associated lactic acidosis. Currently, however, this risk is deemed to be low and guidelines have moved towards the continuation of metformin. We hypothesized that continuing metformin peri-operatively would lower postoperative serum glucose level without an effect on plasma lactate levels. We performed a single-blind multicentre randomized controlled trial in people with type 2 diabetes mellitus scheduled for non-cardiac surgery and continued (MF+ group) or withheld (MF- group) metformin before surgery. The main outcome measures were the differences in peri-operative plasma glucose and lactate levels. We randomized 70 patients (37 MF+ group and 33 MF- group) with type 2 diabetes mellitus. Postoperative glucose levels were similar in the MF+ and the MF- groups (8.2 ± 1.8 vs 8.3 ± 2.3 mmol/L P = .95) Although preoperative lactate levels were slightly higher in the MF+ group compared with the MF- group (1.5 vs 1.2 mmol/L; P = .02), the postoperative lactate levels were not significantly different (1.2 vs 1.0 mmol/L; P = .18). In conclusion, continuation of metformin during elective non-cardiac surgery does not improve glucose control or raise lactate levels to a clinically relevant degree.


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/therapeutic use , Metformin/therapeutic use , Adolescent , Adult , Aged , Aged, 80 and over , Blood Glucose/metabolism , Diabetes Mellitus, Type 2/blood , Female , Humans , Intraoperative Care , Length of Stay/statistics & numerical data , Male , Medication Adherence , Middle Aged , Postoperative Complications/etiology , Single-Blind Method , Treatment Outcome , Young Adult
9.
Anaesthesia ; 73(3): 332-339, 2018 03.
Article in English | MEDLINE | ID: mdl-29230803

ABSTRACT

In this open-label multicentre randomised controlled trial, we investigated three peri-operative treatment strategies to lower glucose and reduce the need for rescue insulin in patients aged 18-75 years with type-2 diabetes mellitus undergoing non-cardiac surgery. Patients were randomly allocated using a web-based randomisation program to premedication with liraglutide (liraglutide group), glucose-insulin-potassium infusion (insulin infusion group) or insulin bolus regimen (insulin bolus group), targeting a glucose < 8.0 mmol.l-1 . The primary outcome was the between group difference in median glucose levels 1 h after surgery. We analysed 150 patients (liraglutide group n = 44, insulin infusion group n = 53, insulin bolus group n = 53) according to the intention-to-treat principle. Median (IQR [range]) plasma glucose 1 h postoperatively was lower in the liraglutide group compared with the insulin infusion and insulin bolus groups (6.6 (5.6-7.7 [4.2-13.5]) mmol.l-1 vs. 7.5 (6.4-8.3 [3.9-16.6]) mmol.l-1 (p = 0.026) and 7.6 (6.4-8.9 [4.7-13.2]) mmol.l-1 ) p = 0.006, respectively). The incidence of hypoglycaemia and postoperative complications did not differ between the groups. Six patients had pre-operative nausea in the liraglutide group, of which two had severe nausea, compared with no patients in the insulin infusion and insulin bolus groups (p = 0.007). The pre-operative administration of liraglutide stabilised peri-operative plasma glucose levels and reduced peri-operative insulin requirements, at the expense of increased pre-operative nausea rates.


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/therapeutic use , Insulin/administration & dosage , Liraglutide/therapeutic use , Perioperative Care , Aged , Blood Glucose/analysis , Diabetes Mellitus, Type 2/blood , Female , Glucose/therapeutic use , Humans , Insulin/therapeutic use , Male , Middle Aged , Potassium/therapeutic use
10.
Br J Anaesth ; 119(6): 1141-1149, 2017 Dec 01.
Article in English | MEDLINE | ID: mdl-29028933

ABSTRACT

Background: Cerebral autoregulation (CA) is the mechanism that maintains constancy of cerebral blood flow (CBF) despite variations in blood pressure (BP). Patients with attenuated CA have been shown to have an increased incidence of peri-operative stroke. Studies of CA in anaesthetized subjects are rare, because a simple and non-invasive method to quantify the integrity of CA is not available. In this study, we set out to improve non-invasive quantification of CA during surgery. For this purpose, we introduce a novel method to amplify spontaneous BP fluctuations during surgery by imposing mechanical positive pressure ventilation at three different frequencies and quantify CA from the resulting BP oscillations. Methods: Fourteen patients undergoing sevoflurane anaesthesia were included in the study. Continuous non-invasive BP and transcranial Doppler-derived CBF velocity (CBF V ) were obtained before surgery during 3 min of paced breathing at 6, 10, and 15 bpm and during surgery from mechanical positive pressure ventilation at identical frequencies. Data were analysed using frequency domain analysis to obtain CBF V -to-BP phase lead as a continuous measure of CA efficacy. Group averages were calculated. Values are means ( sd ), and P <0.05 was used to indicate statistical significance. Results: Preoperative vs intraoperative CBF V -to-BP phase lead was 43 (9) vs 45 (8)°, 25 (8) vs 24 (10)°, and 4 (6) vs -2 (12)° during 6, 10, and 15 bpm, respectively (all P =NS). Conclusions: During surgery, cerebral autoregulation indices were similar to values determined before surgery. This indicates that CA can be quantified reliably and non-invasively using this novel method and confirms earlier evidence that CA is unaffected by sevoflurane anaesthesia. Clinical trial registration: NCT03071432.


Subject(s)
Blood Pressure Determination/methods , Cerebrovascular Circulation/physiology , Homeostasis/physiology , Monitoring, Intraoperative/methods , Positive-Pressure Respiration/methods , Adult , Aged , Female , Humans , Male , Middle Aged , Reproducibility of Results
12.
JIMD Rep ; 34: 49-54, 2017.
Article in English | MEDLINE | ID: mdl-27518779

ABSTRACT

Surgery and anesthesia pose a threat to patients with very long-chain acyl-CoA dehydrogenase deficiency (VLCADD), because prolonged fasting, stress, and pain are known risk factors for the induction of metabolic derangement. The optimal perioperative management in these patients is unknown and the use of volatile agents and agents dissolved in fatty acids has been related to postoperative metabolic complications. However, the occurrence of metabolic derangement is multifactorial and depends, amongst others, on the severity of the mutation and residual enzyme activity. Current guidelines suggest avoiding both volatile anesthetics as well as propofol, which seriously limits the options for providing safe anesthesia. Therefore, we reviewed the available literature on the perioperative management of patients with VLCADD. We concluded that the use of some medications, such as volatile anesthetics, in patients with VLCADD might be wrongfully avoided and could in fact prevent metabolic derangement by the adequate suppression of pain and stress during surgery. We will illustrate this with a case report of an adult VLCADD patient undergoing minor surgery. Besides the use of remifentanil, anesthesia was uneventfully maintained with the use of sevoflurane, a volatile agent, and continuous glucose infusion. The patient was monitored with a continuous glucose meter and creatinine kinase measurements.

13.
Minerva Anestesiol ; 81(9): 951-9, 2015 Sep.
Article in English | MEDLINE | ID: mdl-25592489

ABSTRACT

BACKGROUND: Perioperative hyperglycemia is associated with postoperative complications after major surgery. However, more than 50% of surgical procedures are performed in an ambulatory setting, where glucose is not routinely measured. The objectives of this study were to investigate the change in capillary glucose during ambulatory surgery, to identify patients at risk for perioperative increasing glucose and to evaluate whether hyperglycemia predisposes for complications after ambulatory surgery. METHODS: In this prospective multicenter cohort study, adult patients planned for ambulatory surgery, were included and capillary glucose was measured 1 hour before and 1 hour after surgery. Patients were contacted 90 days after surgery to determine the occurrence of postoperative complications. RESULTS: Nine hundred and nine patients were included, 48 (5.3%) patients had diabetes mellitus (DM). Overall median glucose increased from 5.4 mmol L-1 preoperatively to 5.6 mmol L-1 postoperatively (P<0.001). Hyperglycemia, glucose ≥7.8 mmol L-1, occurred in 8.8% of the patients. Dexamethasone administration (given in 406 [44.7%] patients) was a risk factor for glucose increase (P<0.001). Hyperglycemia was not a risk factor for postoperative complications (OR 1.19, 95%CI 0.57-2.48, P=0.646). However, prediagnosed DM was a risk factor for postoperative complications, independent of hyperglycemia (OR 2.56, 95%CI 1.10-5.97, P=0.030). CONCLUSION: Minor ambulatory surgery is not associated with a clinically relevant increase in glucose. The very small glucose increase we observed could be attributed to the administration of dexamethasone for PONV prophylaxis. Hyperglycemia during ambulatory surgery is not associated with complications after discharge.


Subject(s)
Ambulatory Surgical Procedures/methods , Hyperglycemia/complications , Adult , Aged , Antiemetics/adverse effects , Antiemetics/therapeutic use , Blood Glucose/analysis , Cohort Studies , Dexamethasone/adverse effects , Dexamethasone/therapeutic use , Diabetes Mellitus/blood , Female , Humans , Hyperglycemia/chemically induced , Male , Middle Aged , Perioperative Period , Postoperative Complications/epidemiology , Prospective Studies
15.
Br J Anaesth ; 109(2): 144-54, 2012 Aug.
Article in English | MEDLINE | ID: mdl-22735301

ABSTRACT

Failed epidural anaesthesia or analgesia is more frequent than generally recognized. We review the factors known to influence the success rate of epidural anaesthesia. Reasons for an inadequate epidural block include incorrect primary placement, secondary migration of a catheter after correct placement, and suboptimal dosing of local anaesthetic drugs. For catheter placement, the loss of resistance using saline has become the most widely used method. Patient positioning, the use of a midline or paramedian approach, and the method used for catheter fixation can all influence the success rate. When using equipotent doses, the difference in clinical effect between bupivacaine and the newer isoforms levobupivacaine and ropivacaine appears minimal. With continuous infusion, dose is the primary determinant of epidural anaesthesia quality, with volume and concentration playing a lesser role. Addition of adjuvants, especially opioids and epinephrine, may substantially increase the success rate of epidural analgesia. Adjuvant opioids may have a spinal or supraspinal action. The use of patient-controlled epidural analgesia with background infusion appears to be the best method for postoperative analgesia.


Subject(s)
Analgesia, Epidural/methods , Anesthesia, Epidural/methods , Adjuvants, Anesthesia , Analgesia, Epidural/adverse effects , Analgesia, Epidural/instrumentation , Anesthesia, Epidural/adverse effects , Anesthesia, Epidural/instrumentation , Anesthetics, Local/administration & dosage , Dose-Response Relationship, Drug , Drug Administration Schedule , Equipment Failure , Humans , Patient Positioning/methods , Treatment Failure
16.
Stud Health Technol Inform ; 169: 103-7, 2011.
Article in English | MEDLINE | ID: mdl-21893723

ABSTRACT

Insulin is the most potent agent for the treatment of diabetes mellitus. However insulin treatment requires frequent evaluation of blood glucose levels and adjustment of the insulin dose. This process is called titration. To guide patients with type 2 diabetes using once-daily long-acting insulin, we have developed a web-based decision support system for insulin self-titration. The purpose of this paper is to provide an overview of the phases of development and the final design of the system. We reviewed the literature, consulted an expert panel, and conducted interviews with patients to elicit system requirements. This revealed four important aspects: the insulin titration algorithm, the handling of hypoglycemic events, telemedicine functionalities, and visiting frequency monitoring. We used these requirements to develop a fully functional system.


Subject(s)
Blood Glucose Self-Monitoring/methods , Decision Support Systems, Clinical , Diabetes Mellitus, Type 2/drug therapy , Insulin/administration & dosage , Telemedicine/methods , Blood Glucose/analysis , Drug Administration Schedule , Glycated Hemoglobin/analysis , Humans , Hypoglycemic Agents/therapeutic use , Internet , Program Development , Self Care , Software
17.
Diabet Med ; 28(10): 1158-67, 2011 Oct.
Article in English | MEDLINE | ID: mdl-21294770

ABSTRACT

AIMS: To investigate the efficacy of sensor-augmented pump therapy vs. multiple daily injection therapy in patients with suboptimally controlled Type 1 diabetes. METHODS: In this investigator-initiated multi-centre trial (the Eurythmics Trial) in eight outpatient centres in Europe, we randomized 83 patients with Type 1 diabetes (40 women) currently treated with multiple daily injections, age 18-65 years and HbA(1c) ≥ 8.2% (≥ 66 mmol/mol) to 26 weeks of treatment with either a sensor-augmented insulin pump (n = 44) (Paradigm(®) REAL-Time) or continued with multiple daily injections (n = 39). Change in HbA(1c) between baseline and 26 weeks, sensor-derived endpoints and patient-reported outcomes were assessed. RESULTS: The trial was completed by 43/44 (98%) patients in the sensor-augmented insulin pump group and 35/39 (90%) patients in the multiple daily injections group. Mean HbA(1c) at baseline and at 26 weeks changed from 8.46% (SD 0.95) (69 mmol/mol) to 7.23% (SD 0.65) (56 mmol/mol) in the sensor-augmented insulin pump group and from 8.59% (SD 0.82) (70 mmol/mol) to 8.46% (SD 1.04) (69 mmol/mol) in the multiple daily injections group. Mean difference in change in HbA(1c) after 26 weeks was -1.21% (95% confidence interval -1.52 to -0.90, P < 0.001) in favour of the sensor-augmented insulin pump group. This was achieved without an increase in percentage of time spent in hypoglycaemia: between-group difference 0.0% (95% confidence interval -1.6 to 1.7, P = 0.96). There were four episodes of severe hypoglycaemia in the sensor-augmented insulin pump group and one episode in the multiple daily injections group (P = 0.21). Problem Areas in Diabetes and Diabetes Treatment Satisfaction Questionnaire scores improved in the sensor-augmented insulin pump group. CONCLUSIONS: Sensor augmented pump therapy effectively lowers HbA(1c) in patients with Type 1 diabetes suboptimally controlled with multiple daily injections.


Subject(s)
Blood Glucose/drug effects , Diabetes Mellitus, Type 1/drug therapy , Glycated Hemoglobin/drug effects , Hypoglycemic Agents/administration & dosage , Infusion Pumps, Implantable , Insulin Infusion Systems , Insulin/administration & dosage , Adult , Diabetes Mellitus, Type 1/blood , Equipment Design , Europe/epidemiology , Glycated Hemoglobin/metabolism , Humans , Hypoglycemia/chemically induced , Hypoglycemia/prevention & control , Injections , Male , Middle Aged , Treatment Outcome , Young Adult
18.
J Thromb Haemost ; 8(8): 1663-9, 2010 Aug.
Article in English | MEDLINE | ID: mdl-20492456

ABSTRACT

Diabetes mellitus is characterized by a high risk of atherothrombotic events. What is more, venous thrombosis has also been found to occur more frequently in this patient group. This prothrombotic condition in diabetes is underpinned by laboratory findings of elevated coagulation factors and impaired fibrinolysis. Hyperglycemia plays an important role in the development of these hemostatic abnormalities, as is illustrated by the association with glycemic control and the improvement upon treatment of hyperglycemia. Interestingly, stress induced hyperglycemia, which is often transient, has also been associated with poor outcome in thrombotic disease. Similar laboratory findings suggest a common effect of acute vs. chronic hyperglycemia on the coagulation system. Many mechanisms have been proposed to explain this prothrombotic shift in hyperglycemia, such as a direct effect on gene transcription of coagulation factors caused by hyperglycemia-induced oxidative stress, loss of the endothelial glycocalyx layer, which harbours coagulation factors, and direct glycation of coagulation factors, altering their activity. In addition, both chronic and acute hyperglycemia are often accompanied by hyperinsulinemia, which has been shown to have prothrombotic effects as well. In conclusion, the laboratory evidence of the effects of both chronic and acute hyperglycemia suggests a prothrombotic shift. Additionally, hyperglycemia is associated with poor clinical outcome of thrombotic events. Whether intensive treatment of hyperglycemia can prevent hypercoagulability and improve clinical outcome remains to be investigated.


Subject(s)
Hyperglycemia/physiopathology , Thrombosis/blood , Blood Coagulation , Diabetes Complications/blood , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 2/blood , Fibrinolysis , Humans , Hyperglycemia/complications , Models, Biological , Risk , Thrombosis/pathology
19.
Diabetologia ; 53(4): 593-6, 2010 Apr.
Article in English | MEDLINE | ID: mdl-20225392

ABSTRACT

Continuous subcutaneous glucose monitoring (CGM) is a developing technology in the treatment of diabetes mellitus. The first randomised controlled trials on its efficacy have been performed. In several studies, CGM lowered HbA1c in adult patients with suboptimally controlled type 1 diabetes mellitus, when selecting compliant patients who tolerate the device. However, as a preventive tool for hypoglycaemia, CGM has not fulfilled the great expectations. Increasing reimbursement of CGM is expected in the near future, awaiting studies on cost-effectiveness.


Subject(s)
Blood Glucose/analysis , Diabetes Mellitus, Type 1/blood , Glycated Hemoglobin/analysis , Adult , Child , Cost of Illness , Humans , Hypoglycemia/epidemiology , Hypoglycemia/prevention & control , Monitoring, Ambulatory/economics , Monitoring, Ambulatory/methods , Randomized Controlled Trials as Topic
20.
Neth J Med ; 67(6): 226-9, 2009 Jun.
Article in English | MEDLINE | ID: mdl-19749392

ABSTRACT

BACKGROUND: A frequent complication of orthopaedic procedures is venous thromboembolism (VTE ). Hyperglycaemia has been shown to activate the coagulation system and is associated with postoperative morbidity and mortality. Therefore, we hypothesised that glucose levels increase during orthopaedic surgery and are associated with an activation of the coagulation system. METHODS: Nine adult patients undergoing elective hip replacement were included. Venous blood samples were taken before, during and after surgery. Plasma glucose levels, factor VIII clotting activity (fVIII:c), von Willebrand ristocetin cofactor activity, von Willebrand factor antigen and prothrombin fragment 1+2 were measured. RESULTS: Immediately after induction of anaesthesia, plasma glucose levels started to increase until the second day postoperatively (peak 8.0 mmol/l). After seven weeks glucose values had returned to baseline (6.1 mmol/l), p<0.001 with ANOVA. All coagulation parameters increased during surgery, subsequent to the rise in glucose. The change in mean FVIII:c and von Willebrand ristocetin cofactor activity was significantly correlated with mean glucose values. CONCLUSIONS: These observations indicate that total hip replacement surgery causes an increase in glucose levels that precedes the proportional rise of the measured coagulation parameters. This suggests a possible role of glucose in the activation of the coagulation system during hip surgery.


Subject(s)
Arthroplasty, Replacement, Hip/adverse effects , Blood Coagulation Disorders/etiology , Hip/surgery , Hyperglycemia/etiology , Stress, Physiological , Stress, Psychological/complications , Venous Thromboembolism/etiology , Analysis of Variance , Blood Glucose , Confidence Intervals , Factor VIII , Humans , Orthopedic Procedures/adverse effects , Risk Factors , Statistics as Topic , Time Factors , von Willebrand Factor/immunology
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