First fully endoscopic metabolic procedure with NOTES gastrojejunostomy, controlled bypass length and duodenal exclusion: a 9-month porcine study

AbstractWe conducted a pilot study of a potential endoscopic alternative to bariatric surgery. We developed a Natural Orifice Transluminal Endoscopic Surgery (NOTES) gastric bypass with controlled bypass limb length using four new devices including a dedicated lumen-apposing metal stent (GJ-LAMS) and pyloric duodenal exclusion device (DED). We evaluated procedural technical success, weight change from baseline, and adverse events in growing Landrace/Large-White pigs through 38 weeks after GJ-LAMS placement. Six pigs (age 2.5 months, mean baseline weight 26.1 ± 2.7 kg) had initial GJ-LAMS placement with controlled bypass limb length, followed by DED placement at 2 weeks. Technical success was 100%. GJ-LAMS migrated in 3 of 6, and DED migrated in 3 of 5 surviving pigs after mucosal abrasion. One pig died by Day 94. At 38 weeks, necropsy showed 100–240 cm limb length except for one at 760 cm. Weight gain was significantly lower in the pigs that underwent endoscopic bypass procedures compared to expected weight for age. This first survival study of a fully endoscopic controlled bypass length gastrojejunostomy with duodenal exclusion in a growing porcine model showed high technical success but significant adverse events. Future studies will include procedural and device optimizations and comparison to a control group.

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Management of walled-off necrosis with nasocystic irrigation with hydrogen peroxide versus biflanged metal stent: randomized controlled trial

Endoscopy International Open ◽

10.1055/a-1480-7115 ◽

2021 ◽

Vol 09 (07) ◽

pp. E1108-E1115

Author(s):

Sudhir Maharshi ◽

Shyam Sunder Sharma ◽

Sandeep Ratra ◽

Bharat Sapra ◽

Dhruv Sharma

Keyword(s):

Hydrogen Peroxide ◽

Adverse Events ◽

Clinical Success ◽

Controlled Trial ◽

Procedure Time ◽

Metal Stent ◽

Technical Success ◽

Group A ◽

Group B ◽

Walled Off Necrosis

Abstract Background and study aims Walled-off necrosis (WON) is a known complication of acute necrotizing pancreatitis (ANP). There is no study comparing nasocystic irrigation with hydrogen peroxide (H2O2) versus biflanged metal stent (BMS) in the management of WON. The aim of this study was to compare the clinical efficacy of both the treatment strategies. Patients and methods This study was conducted on patients with symptomatic WON who were randomized to nasocystic irrigation with H2O2 (Group A) and BMS placement (Group B). Primary outcomes were clinical and technical success while secondary outcomes were procedure time, adverse events, need for additional procedures, duration of hospitalization, and mortality. Results Fifty patients were randomized into two groups. Group A (n = 25, age 37.8 ± 17.6 years, 16 men) and Group B (n = 25, age 41.8 ± 15.2 years, 17 men). There were no significant differences in baseline characteristics between the two groups. The most common etiology of pancreatitis was alcohol, observed in 27 (54 %) patients. Technical success (100 % vs 96 %, P = 0.98), clinical success (84 % vs 76 %, P = 0.76), requirement of additional procedures (16 % vs 24 %, P = 0.70) and adverse events (4 vs 7, P = 0.06) were comparable in both the groups. The duration to clinical success (34.4 ± 12 vs 14.8 ± 10.8 days, P = 0.001) and procedure time (36 ± 15 vs 18 ± 12 minutes, P = 0.01) were longer in Group A compared to Group B. Conclusions Nasocystic irrigation with H2O2 and BMS are equally effective in the management of WON but time to clinical success and procedure time is longer with nasocystic irrigation.

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Impact of trainee involvement on the outcome of ERCP procedures: results of a prospective multicenter observational trial

Endoscopy ◽

10.1055/a-1049-0359 ◽

2019 ◽

Vol 52 (02) ◽

pp. 115-122 ◽

Cited By ~ 3

Author(s):

Theodor Voiosu ◽

Ivo Boskoski ◽

Andrei M. Voiosu ◽

Andreea Benguș ◽

Agata Ladic ◽

...

Keyword(s):

Adverse Events ◽

Multivariable Analysis ◽

Difficulty Level ◽

Control Group ◽

Technical Success ◽

Endoscopic Techniques ◽

Trainee Group ◽

Standard Report ◽

Multicenter Prospective Observational Study

Abstract Background Training in advanced endoscopic techniques such as endoscopic retrograde cholangiopancreatography (ERCP) should be driven by key performance measures and standardized competence assessment in order to provide safe and high-quality interventions. We aimed to determine whether the involvement of trainees influences the outcome of the procedure and the incidence of ERCP-related adverse events. Methods This was an international, multicenter, prospective, observational study conducted at six high- and low-volume centers across Europe between October 2016 and October 2018, and included independent operators and their trainees. Standard report forms documenting indication, trainee involvement, technical outcome, and complications over a 30-day follow-up of consecutive ERCP procedures were included in the analysis. Technical success of the procedure and procedure-related adverse events were compared between procedures in the trainee group and the control group using bivariable and multivariable analysis. Results 21 trainees and 16 control endoscopists performed 1843 ERCPs during the study period. Trainee involvement in ERCP procedures did not decrease technical success (92.4 % vs. 93.7 %; P = 0.30) or increase the risk of adverse events (14.7 % vs. 14.6 %; P > 0.99). Conversely, there were significantly more moderate or severe adverse events in the control group compared with the trainee group (6.2 % vs. 3.4 %, P = 0.01). On multivariable analysis, only increased bilirubin levels, time to cannulation, and procedure difficulty level increased the risk of any procedure-related adverse event. Conclusion Trainee involvement in ERCP interventions within a proper teaching setting is safe and does not compromise the success of the procedure.

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Peroral cholecystoscopy using a multibending ultraslim endoscope through a lumen-apposing metal stent for endoscopic ultrasound-guided gallbladder drainage: a feasibility study

Endoscopy ◽

10.1055/a-1518-7039 ◽

2021 ◽

Author(s):

Hae Won Yoo ◽

Jong Ho Moon ◽

Yun Nah Lee ◽

Yeon Han Song ◽

Jae Kook Yang ◽

...

Keyword(s):

Adverse Events ◽

Endoscopic Ultrasound ◽

Primary Outcome ◽

Narrow Band Imaging ◽

Endoscopic Examination ◽

Metal Stent ◽

Technical Success ◽

Ultrasound Guided ◽

Gallbladder Drainage ◽

Technical Success Rate

Background Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS) has rendered endoscopic gallbladder assessment through a stent possible, but an appropriate endoscope is required. We assessed the feasibility of peroral cholecystoscopy (POCC) using a multibending ultraslim endoscope passed through a LAMS after EUS-GBD. Methods 14 patients with a LAMS for EUS-GBD who consecutively underwent POCC were included. POCC was performed using a multibending endoscope inserted through the LAMS. The primary outcome was the technical success rate, defined as complete endoscopic examination of the gallbladder from the orifice of the cystic duct to the fundus. The types of intervention and adverse events were recorded. Results 17 POCCs were performed in 14 patients. Of the 17 POCCs, 15 (88.2 %) were technically successful. Narrow-band imaging endoscopy was performed in 12 procedures (70.6 %), and cholecystoscopy-guided target biopsies were obtained in six. Gallstone extraction was performed in two patients. After POCC, all LAMSs remained stable and no adverse events were observed. Conclusions POCC using a multibending ultraslim endoscope can be effectively and safely performed through a LAMS after EUS-GBD.

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Technical and clinical outcomes of endoscopic retrograde cholangiopancreatography (ERCP) procedures performed in patients with COVID-19

Therapeutic Advances in Gastroenterology ◽

10.1177/1756284820980671 ◽

2020 ◽

Vol 13 ◽

pp. 175628482098067

Author(s):

Theodor Voiosu ◽

Andrei Voiosu ◽

Ivo Boškoski ◽

Marianna Arvanitakis ◽

Michiel Bronswijk ◽

...

Keyword(s):

Adverse Events ◽

Endoscopic Retrograde Cholangiopancreatography ◽

Multivariable Analysis ◽

Secondary Outcome ◽

Control Group ◽

Minimal Risk ◽

Technical Failure ◽

Success Rates ◽

Technical Success ◽

Endoscopic Retrograde

Background: The unprecedented situation caused by the coronavirus disease 2019 (COVID-19) pandemic has profoundly affected endoscopic practice in regard to access, volume, and workflow. We aimed to assess the potential changes in the technical outcomes of endoscopic retrograde cholangiopancreatography (ERCP) procedures carried out in patients with confirmed SARS-CoV-2 infection. Methods: We conducted an international, multicenter, retrospective, matched case-control study of ERCP procedures carried out in patients with confirmed COVID-19. The main outcome was technical success of the procedure as assessed by the endoscopist, and the secondary outcome was the development of procedure-related adverse events. Each case was matched in a 1:4 ratio with controls extracted from each center’s database in order to identify relevant changes in outcome measures compared with the pre-pandemic era. Results: Eighteen procedures performed in 16 COVID-19 patients [14 men, 65 years (9–82)] and 67 controls were included in the final analysis. Technical success was achieved in 14/18 COVID-19 cases, which was significantly lower as compared with the control group (14/18 versus 64/67, p = 0.034), with an endoscopic reintervention required in 9/18 cases. However, the rate of procedure-related adverse events was low in both groups (1/18 versus 10/67, p = 0.44). On multivariable analysis, COVID-19 status remained the only risk factor for technical failure of the procedure [odds ratio of 19.9 (95% confidence interval 1.4–269.0)]. Conclusions: The COVID-19 pandemic has affected the volume and practice of ERCP, resulting in lower technical success rates without significantly impacting patient safety. Prioritizing cases and following recommendations on safety measures can ensure good outcome with minimal risk in dedicated centers.

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ERCP with overtube-assisted enteroscopy in patients with Roux-en-Y gastric bypass anatomy: a systematic review and meta-analysis

Endoscopy ◽

10.1055/a-1178-9741 ◽

2020 ◽

Vol 52 (10) ◽

pp. 824-832

Author(s):

Jagpal Singh Klair ◽

Mahendran Jayaraj ◽

Viveksandeep Thoguluva Chandrasekar ◽

Harshith Priyan ◽

Joanna Law ◽

...

Keyword(s):

Systematic Review ◽

Gastric Bypass ◽

Adverse Events ◽

Significant Variation ◽

Meta Analysis ◽

Technical Success ◽

Endoscopic Retrograde ◽

Invasive Approach ◽

Future Studies ◽

Substantial Heterogeneity

Abstract Background Endoscopic retrograde cholangiopancreatography (ERCP) in patients with Roux-en-Y gastric bypass (RYGB) anatomy is challenging. Overtube-assisted enteroscopy (OAE) is usually needed to perform ERCP in these patients. There is significant variation in the reported rates of success and adverse events across published studies. We performed a systematic review and meta-analysis to reliably estimate the pooled rates of success and adverse events. Methods We performed a systematic search of multiple electronic databases through February 2020 to identify studies reporting outcomes of OAE-ERCP in post-RYGB patients. The pooled rates of enteroscopy success, technical success, and adverse events were estimated for OAE-ERCP. The pooled rates of success and adverse events were also estimated for ERCP using double-balloon enteroscopes (DBE) alone. Results 10 studies reporting a total of 398 procedures were included in the meta-analysis. The pooled rates of enteroscopy and technical success of OAE-ERCP were 75.3 % (95 % confidence interval [CI] 64.5 – 83.6) and 64.8 % (95 %CI 53.1 – 74.9) respectively. The pooled rate of adverse events was 8.0 % (95 %CI 5.2 – 12.2). The pooled rates of enteroscopy and technical success of DBE-ERCP (four studies) were 83.5 % (95 %CI 68.3 – 92.2) and 72.5 % (95 %CI 52.3 – 86.4), respectively. The pooled rate of adverse events with DBE-ERCP was 9.0 % (95 %CI 5.4 – 14.5). Substantial heterogeneity was noted. Conclusions OAE-ERCP appears to be effective and safe in post-RYGB patients. Among the currently available techniques, OAE-ERCP is the least invasive approach in this challenging group of patients. Future studies comparing the effectiveness and safety of alternative novel techniques, such as endosonography-directed transgastric ERCP, with OAE-ERCP are needed.

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Trainee involvement increases precut rates and delays access to the common bile duct without an increase in procedure-related adverse events: a brave new world of ERCP training?

Romanian Journal of Internal Medicine ◽

10.1515/rjim-2017-0041 ◽

2018 ◽

Vol 56 (1) ◽

pp. 55-61 ◽

Cited By ~ 1

Author(s):

Theodor Voiosu ◽

Andrei Voiosu ◽

Andreea Benguş ◽

Mihai Rimbaş ◽

Bogdan Mateescu

Keyword(s):

Adverse Events ◽

Standard Form ◽

Final Analysis ◽

Control Group ◽

Technical Success ◽

Related Data ◽

Trainee Group ◽

Increased Risk ◽

Selective Cannulation ◽

The Impact

Abstract Background and aims. Selective cannulation of the desired duct is a key element in ERCP procedures and an important step in the training of fellows. However, there is limited data about technical success and patient safety for ERCPs conducted in a training setting.We aimed to evaluate the impact of trainee involvement on the cannulation technique and procedure related outcomes at ERCP. Materials and methods. We conducted an observational study of all ERCP conducted in an endoscopy unit with an on-going training program. Patient related data and procedure-related data (method of cannulation, time to cannulation, degree of trainee involvement, technical success and procedure-related adverse events) were collected using a standard form. The method of cannulation, time to cannulation and procedure-related adverse events were compared between ERCPs with trainee involvement and those without. Results. 641 consecutive ERCPs were evaluated and 474 native papilla cases performed by 4 trainers and 3 trainees were included in the final analysis. Trainees were involved in 171 procedures (36.1%), achieving cannulation of the desired duct in 50.8% of the cases. Cannulation rates were similar in the trainee group compared to the control group (91.7% vs. 88.7%) and there was no increase in the rate of adverse events. However, cannulation time was significantly longer in the trainee group with a significant increase in the rate of precut use (32.1% vs. 23.4%, p < 0.001). Conclusions. Trainee involvement resulted in longer cannulation times and increased use of precut sphincterotomy, but, was not associated with an increased risk of procedure related adverse events.

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Endoscopic ultrasound-guided choledochoduodenostomy using partially-covered self-expandable metal stent in patients with malignant distal biliary obstruction and unsuccessful ERCP

Endoscopy International Open ◽

10.1055/s-0043-120664 ◽

2018 ◽

Vol 06 (01) ◽

pp. E67-E72 ◽

Cited By ~ 7

Author(s):

Praveer Rai ◽

CR Lokesh ◽

Amit Goel ◽

Rakesh Aggarwal

Keyword(s):

Adverse Events ◽

Biliary Drainage ◽

Biliary Obstruction ◽

Patency Rate ◽

Clinical Success ◽

Metal Stent ◽

Technical Success ◽

Ultrasound Guided ◽

Stent Patency ◽

Post Procedure

Abstract Background and study aims Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) is an alternative to percutaneous transhepatic biliary drainage (PTBD) for patients with malignant distal biliary obstruction in whom ERCP has failed. We studied technical success, clinical success, stent patency rate and occurrence of adverse events in patients undergoing EUS-CDS with partially-covered self-expanding metal stent (PCSEMS). Patients and methods Medical records of consecutive patients with unresectable malignant distal biliary obstruction requiring biliary drainage who underwent EUS-CDS because of failure of attempt at ERCP were reviewed. EUS-CDS was done using 6-cm, PCSEMS (Wallflex, Boston Scientific). Technical success, clinical success (more than 50 % reduction in total bilirubin at 2 weeks post-procedure), stent patency rate and adverse events (AEs) were assessed. Patients were followed up for 3 months post-procedure. Results Between January 2015 and December 2016, 30 patients underwent EUS-CDS, including 20 (67 %) with failed biliary cannulation and 10 (33 %) with duodenal stenosis. Technical success was achieved in 28 patients, all of whom also had clinical success. Median total serum bilirubin decreased from 20 mg/dL to 5 mg/dL at 2 weeks post-procedure. Three patients (10 %) had adverse events (bile leak, hemobilia, stent block in one patient each; no stent migration); none of these adverse events was major and all were managed successfully. There were no procedure-related deaths. Five patients died of disease progression in the 3-month period post-procedure, and the 3-month dysfunction-free stent patency rate was 83 %. Conclusion EUS-CDS with a PCSEMS has a high technical and clinical success. Adverse events were infrequent, minor and could be managed easily.

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COMPERATIVE STUDY OF THE REGULATIES OF FAT DEPOSIT IN THE DIFFERENT PARTS OF TRUNK OF YOUNG PIGS OF THE LARGE WHITE AND MYRGOROD BREEDS

Animal Breeding and Genetics ◽

10.31073/abg.52.16 ◽

2016 ◽

Vol 52 ◽

pp. 128-133

Author(s):

I. V. Khatko ◽

A. O. Onyshchenko ◽

V. O. Vovk ◽

T. M. Konks

Keyword(s):

Statistical Processing ◽

Fat Deposition ◽

Thoracic Vertebra ◽

Control Group ◽

Large White ◽

Young Pigs ◽

Fat Deposits ◽

Fat Thickness ◽

The Difference ◽

Different Parts

The modern state of social-economic processes development demands increasing the level of food safety of the state, especially providing population by the high quality foods of domestic production, specifically by pork. One of criteria for estimating pigs' meatness is determining the fat thickness in different points of a trunk. The informative content of measuring in different parts of a trunk is different and it needs detailed study. The fat thickness is the most common as trait for pigs' meatness in the practice of pig breeding because it has high correlation with meat yield in carcasses. The aim of our research was the comparative study of fat deposition regularities in different parts of a trunk of Large White and Mirgorod pigs in different age periods. For conducting researches 24 pigs of both breeds with average live weight about 40 kg and at age not more 4 months were selected. The fat thickness was measured at live animals using ultrasonic device Draminski in such points: on withers, the level of the 6-7th thoracic vertebra, the level of the 1st-2nd loins vertebra and sacrum. Measuring the fat thickness was carried out at the age of 4, 5, 6, 7 and 8 months. During researches it was carried out the statistical processing of obtained material. Reliability of obtained indexes of productivity was determined. Regularities of formatting fat thickness and fat deposition rate depending on the age were studied. For the results of researches it has been studied and compared economically valuable traits of the most spread domestic pigs of Large White and Mirgorod breeds. By comparative study of growth and development of young pigs of experimental and control groups it has been found that animals of Large White breed differed by lesser fat deposits in all points of measuring. Thus, at 6-months’ age they had lesser thickness of fat in all parts of a trunk. More expressed tendency was at withers and the level of the 6-7th thoracic vertebra, at that in the first case the difference between groups was reliable (p < 0.01). The fat deposition rate in young pigs of both breeds was not the same in different points of measuring along a trunk. Above mentioned tendencies were intensified with the age. Purebred animals of intrabreed type LW-1 at 7-months’ age had reliable less thickness of fat in comparison with the control group: on withers (p < 0.01), at the level of the 6-7th thoracic vertebra, the level of the 1st-2nd loins vertebra (p < 0.05) and on sacrum (p < 0.01). In future, according to economic and scientific expediency, the animals of Mirgorod breed were excluded from the experiment. Concerning Large White breed, the researches were finished when animals were at 8 months’ age. The process of fat deposition in Large White pigs was less intensive in comparison to Mirgorod breed. The highest relative rate of fat thickness increase in both breeds was observed at the level of the 1st-2nd loins vertebra. By statistical processing of the obtained materials it has been found that the difference of average arithmetical indexes (as absolute and relative) between the experimental and control groups during growth and development had distinct tendency to increasing in all points of measuring. The reliability of the difference between the averages in groups with the age of animals increased. A higher reliability of data was obtained at measuring of the front parts of a trunk of pigs at the level of the 6th-7th thoracic vertebra and on withers. The carried out researches at all points of measuring give the reason to confirm that the fat deposits of Large White pigs are less comparing to Mirgorod breed. Conclusions. 1. Carcasses of animals of intrabreed type ULW-1 are comparatively more technologically suitable and economically beneficial for agricultural proceeding industry. 2. Animals of intrabreed type ULW-1 at 7-months’ age had reliable less thickness of fat in comparison with the control group: on withers, at the level of the 6-7th thoracic vertebra, the level of the 1st-2nd loins vertebra and on sacrum. 3. The process of fat deposition in Large White pigs was less intensive in comparison to Mirgorod breed.

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Efficacy and Safety of Non-Steroidal Anti-Androgens in Patients with Metastatic Prostate Cancer: Meta-Analysis of Randomized Controlled Trials

Reviews on Recent Clinical Trials ◽

10.2174/1574887114666191105152404 ◽

2020 ◽

Vol 15 (1) ◽

pp. 34-47 ◽

Cited By ~ 1

Author(s):

Muhammed Rashid ◽

Madhan Ramesh ◽

K. Shamshavali ◽

Amit Dang ◽

Himanshu Patel ◽

...

Keyword(s):

Prostate Cancer ◽

Adverse Events ◽

Randomized Controlled Trials ◽

Quality Assessment ◽

Cochrane Library ◽

Control Group ◽

Controlled Trials ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Significant Difference

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.

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An Internet-based health gateway device for interactive communication and automatic data uploading: Clinical efficacy for type 2 diabetes in a multi-centre trial

Journal of Telemedicine and Telecare ◽

10.1177/1357633x16657500 ◽

2016 ◽

Vol 23 (6) ◽

pp. 595-604 ◽

Cited By ~ 15

Author(s):

Jae Hyoung Cho ◽

Hun-Sung Kim ◽

Seung Hyun Yoo ◽

Chang Hee Jung ◽

Woo Je Lee ◽

...

Keyword(s):

Adverse Events ◽

Healthcare System ◽

Glucose Control ◽

Large Scale ◽

Diabetes Management ◽

Intervention Group ◽

Diabetes Control ◽

Control Group ◽

Anthropometric Parameters ◽

Automatic Data

Introduction The aim of this study was to improve the quality of diabetes control and evaluate the efficacy of an Internet-based integrated healthcare system for diabetes management and safety. Methods We conducted a large-scale, multi-centre, randomized clinical trial involving 484 patients. Patients in the intervention group ( n = 244) were treated with the Internet-based system for six months, while the control group ( n = 240) received the usual outpatient management over the same period. HbA1c, blood chemistries, anthropometric parameters, and adverse events were assessed at the beginning of the study, after three months, and the end of the study. Results There were no initial significant differences between the groups with respect to demographics and clinical parameters. Upon six-month follow-up, HbA1c levels were significantly decreased from 7.86 ± 0.69% to 7.55 ± 0.86% within the intervention group ( p < 0.001) compared to 7.81 ± 0.66% to 7.70 ± 0.88% within the control group. Postprandial glucose reduction was predominant. A subgroup with baseline HbA1c higher than 8% and good compliance achieved a reduction of HbA1c by 0.8 ± 1.05%. Glucose control and waist circumference reduction were more effective in females and subjects older than 40 years of age. There were no adverse events associated with the intervention. Discussion This e-healthcare system was effective for glucose control and body composition improvement without associated adverse events in a multi-centre trial. This system may be effective in improving diabetes control in the general population.

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