Yuan 2015.
| Study characteristics | ||
| Methods | Study design: parallel randomised controlled clinical trial | |
| Participants |
Inclusion criteria: adults with type 2 diabetes mellitus (DM) undergoing gastrectomy for gastric tumours between September 2006 and March 2014 Exclusion criteria: participants were excluded if (1) a withdrawal request was made by the participant or surrogate; (2) the participant underwent laparotomy or palliative surgery; (3) the participant was unable to tolerate enteral nutrition, as shown by vomiting, diarrhoea or abdominal distention; or (4) the nasojejunal tube became occluded or was pulled out Diagnostic criteria: type 2 DM was diagnosed according to the criteria of the American Diabetes Association and gastric tumours were diagnosed endoscopically or by imaging modalities before surgery Setting: First Affiliated Hospital of Zhengzhou University Age group: adults Gender distribution: females and males Country where trial was performed: China |
|
| Interventions |
Intervention(s): intensive glycaemic (IG) management, with continuous insulin infusion to a target blood glucose concentration 4.4 mmol/L to 6.1 mmol/L (80 mg/dL to 110 mg/dL) Comparator(s): conventional glycaemic (CG) management, with intermittent bolus insulin to a target blood glucose concentration < 11.1 mmol/L (< 200 mg/dL) Duration of intervention: — Duration of follow‐up: — Run‐in period: none Number of study centres: 1 Treatment before trial: Intervention: insulin 71 (67%), oral antidiabetic agents 25 (23.6%), none 10 (9.4%) Comparator: insulin 67 (63.2%), oral antidiabetic agents 30 (28.3%), none 9 (8.5%) |
|
| Outcomes | Reported outcome(s) in full text of publication: outcomes included blood glucose concentrations, insulin administration, and postoperative morbidity and mortality | |
| Study registration |
Trial identifier: — Trial terminated early: no |
|
| Publication details |
Language of publication: English Funding: supported by the National Nature Science Foundation of China, Grant No. 81201955 Publication status: peer‐reviewed journal |
|
| Stated aim of study | Quote: "This study assessed whether intensive glycaemic control was well‐tolerated, safe, and improved clinical outcomes in diabetic patients receiving enteral nutrition after gastrectomy" | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “Patients were randomly assigned …” Comment: described as randomised but no additional details provided |
| Allocation concealment (selection bias) | Unclear risk | Quote: “Patients were randomly assigned …” Comment: described as randomised but no additional details provided |
| Blinding of participants and personnel (performance bias) All‐cause mortality | Low risk | Comment: open to personnel. Participants in the control group were managed according a protocol (e.g. insulin administration every 4 to 6 hours) that revealed to which group each participant was allocated; outcome measure unlikely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Hypoglycaemic episodes | High risk | Comment: open to personnel. Participants in the control group were managed according a protocol (e.g. insulin administration every 4 to 6 hours) that revealed to which group each participant was allocated; outcome measure likely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Adverse events other than hypoglycaemic episodes | High risk | Comment: open to personnel. Participants in the control group were managed according a protocol (e.g. insulin administration every 4 to 6 hours) that revealed to which group each participant was allocated; outcome measure likely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Cardiovascular events | High risk | Comment: open to personnel. Participants in the control group were managed according a protocol (e.g. insulin administration every 4 to 6 hours) that revealed to which group each participant was allocated; outcome measure likely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Renal failure | Low risk | Comment: open to personnel. Participants in the control group were managed according a protocol (e.g. insulin administration every 4 to 6 hours) that revealed to which group each participant was allocated; outcome measure unlikely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Infection events | High risk | Comment: open to personnel. Participants in the control group were managed according a protocol (e.g. insulin administration every 4 to 6 hours) that revealed to which group each participant was allocated; outcome measure likely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Mean blood glucose during intervention | High risk | Comment: open to personnel. Participants in the control group were managed according a protocol (e.g. insulin administration every 4 to 6 hours) that revealed to which group each participant was allocated; outcome measure likely influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Infection events | Unclear risk | Comment: open‐label study |
| Blinding of outcome assessment (detection bias) All‐cause mortality | Low risk | Comment: open‐label study; outcome measure unlikely influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Hypoglycaemic episodes | Unclear risk | Comment: open‐label study |
| Blinding of outcome assessment (detection bias) Adverse events other than hypoglycaemic episodes | Unclear risk | Comment: open‐label study |
| Blinding of outcome assessment (detection bias) Cardiovascular events | Unclear risk | Comment: open‐label study |
| Blinding of outcome assessment (detection bias) Renal failure | Low risk | Comment: open‐label study; outcome measure unlikely influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Mean blood glucose during intervention | High risk | Comment: open‐label study |
| Incomplete outcome data (attrition bias) All‐cause mortality | Low risk | Comment: probably no attrition |
| Incomplete outcome data (attrition bias) Hypoglycaemic episodes | Low risk | Comment: probably no attrition |
| Incomplete outcome data (attrition bias) Adverse events other than hypoglycaemic episodes | Low risk | Comment: probably no attrition |
| Incomplete outcome data (attrition bias) Cardiovascular events | Low risk | Comment: probably no attrition |
| Incomplete outcome data (attrition bias) Renal failure | Low risk | Comment: probably no attrition |
| Incomplete outcome data (attrition bias) Infection events | Unclear risk | Comment: probably no attrition |
| Incomplete outcome data (attrition bias) Mean blood glucose during intervention | High risk | Comment: probably no attrition |
| Selective reporting (reporting bias) | Unclear risk | Comment: trial protocol or register record unavailable. The outcomes of interest were described ambiguously |
| Other bias | Low risk | Nothing detected |
—: not reported
ACE: angiotensin‐converting‐enzyme; ADA: American Diabetes Association; ASA: American Society of Anesthesiologists; BG: blood glucose; BMI: body mass index; C: comparator; CABG: coronary artery bypass graft; CHF: congestive heart failure; CII: continuous insulin infusion; COPD: chronic obstructive pulmonary disease; CPB: cardiopulmonary bypass; DM: diabetes mellitus; ECG: electrocardiogram; GGI: glucometer‐guided insulin; HLA‐DR: human leukocyte antigen – DR isotype; HOMA‐IR: homeostatic model assessment for insulin resistance; HTN: hypertension; I: intervention; ICU: intensive care unit; MI: myocardial infarction; NPR: neutral protamine Hagedorn; PMN: polymorphonuclear cells; SICU: surgical intensive care unit; SOFA: sequential organ failure assessment; STS: Society of Thoracic Surgeons