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. 2016 Jan 21;2016(1):CD011281. doi: 10.1002/14651858.CD011281.pub2
  Endpoints quoted in trial document(s)
 (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a Study results posted in trial register, publications specified in trial register Endpoints quoted in publication(s)b,c Endpoints quoted in abstract of publication(s)b,c
Umpierrez 2004a N/T Primary outcome measure(s): response to medical therapy: the time required for resolution of hyperglycaemia and ketoacidosis, and the rate of hypoglycaemia during insulin infusion Primary outcome measure(s):
Secondary outcome measure(s): Secondary outcome measure(s):
Other outcome measure(s): levels of blood glucose, electrolytes, phosphorus, venous pH, beta‐hydroxybutyrate, free fatty acids, insulin; medical care data (site of admission and treatment in the hospital, amount of fluid and insulin administration, length of hospitalisation); deaths Other outcome measure(s): duration of treatment until correction of hyperglycaemia and resolution of ketoacidosis, deaths, length of hospital stay, amount of insulin until resolution of diabetic ketoacidosis, rate of hypoglycaemia, hospitalisation charges
Umpierrez 2004b N/T Primary outcome measure(s): time to resolve ketoacidosis Primary outcome measure(s):
Secondary outcome measure(s): Secondary outcome measure(s):
Other outcome measure(s): levels of glucose, electrolytes, phosphorus, venous pH, beta‐hydroxybutyrate, free fatty acids, insulin; response to medical
 therapy (time and amount of insulin required for resolution of hyperglycaemia and ketoacidosis and the number of hypoglycaemic events during therapy) Other outcome measure(s): duration of treatment until resolution of hyperglycaemia and ketoacidosis, total length of hospitalisation, amount of insulin administration until resolution of hyperglycaemia and ketoacidosis, number of hypoglycaemic events
Della Manna 2005 N/T Primary outcome measure(s): Primary outcome measure(s): ‐
Secondary outcome measure(s): Secondary outcome measure(s): ‐
Other outcome measure(s): blood glucose, blood gas, beta‐hydroxybutyrate, electrolytes, phosphate, magnesium, urea nitrogen, creatinine, urine ketones; resolution of metabolic acidosis and ketosis, DKA recovery; (near) deaths, cerebral oedema; hypoglycaemic episodes Other outcome measure(s): blood glucose, blood gas, beta‐hydroxybutyrate, electrolytes, metabolic acidosis and ketosis, DKA recovery
Ersöz 2006 N/T Primary outcome measure(s): Primary outcome measure(s):
Secondary outcome measure(s): Secondary outcome measure(s):
Other outcome measure(s): serum glucose, pH, beta‐hydroxybutyrate, electrolytes, urine ketone levels and urinary output, lipids; resolution of ketoacidosis, time elapsed until normalisation of the monitored parameters, total amount of insulin delivered until resolution of DKA; mortality, hypoglycaemic events Other outcome measure(s): time needed for normalisation of serum glucose, beta‐hydroxybutyrate, blood pH and urine ketone levels; mortality, serious side effects
Karoli 2011 N/T Primary outcome measure(s): Primary outcome measure(s):
Secondary outcome measure(s): Secondary outcome measure(s):
Other outcome measure(s): blood glucose levels, resolution of DKA, response to therapy was assessed by time and amount of insulin required for resolution of hyperglycaemia and ketoacidosis, number of hypoglycaemic events; duration of hospital stay; deaths Other outcome measure(s): response to therapy (duration of treatment and amount of insulin administered until resolution of hyperglycaemia and ketoacidosis, total length of hospital stay, and number of hypoglycaemic events); mortality
‐ denotes not reported
aTrial document(s) refers to all available information from published design papers and sources other than regular publications (e.g. FDA/EMA documents, manufacturers' websites, trial registers)
 bPublication(s) refers to trial information published in scientific journals (primary reference, duplicate publications, companion documents, or multiple reports of a primary study)
 cOther outcome measures refer to all outcomes not specified as primary or secondary outcome measures
DKA: diabetic ketoacidosis; EMA: European Medicines Agency; FDA: US Food and Drug Administration; N/T: no trial document available