N/A N=130 Randomized Treatment

Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia

Hyperglycemias

Bottom Line

View on ClinicalTrials.gov: NCT00353431 ↗

Enrolled (actual)

130

Serious AEs

0.0%

Results posted

May 2012

Primary outcome: Primary: Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours — 13.0; 22.5 hours

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Novorapid ®, Novo Nordisk, Denmark (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University Hospital, Basel, Switzerland
Primary completion: Apr 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours	13.0; 22.5	—
SECONDARY Time to Reach the Target Range	24.3; 11.8	—
SECONDARY Frequency of Hypoglycemia	4; 13	—
SECONDARY Frequency of Severe Hypoglycaemia	0; 1	—
SECONDARY Frequency of Hypokalaemia	15; 15	—

Summary

The aim of this study is to test the safety and efficacy of a new algorithm for intensive s.c. insulin injection in medical emergency patients with hyperglycaemia (plasma glucose concentration ≥ 8 mmol/l)

Eligibility Criteria

Inclusion Criteria

all patients with hyperglycaemia (≥ 8.0 mmol/l) admitted to the medical emergency room.
patients with presumed hospitalisation in ER or medical ward of more than 48 h duration.

Exclusion Criteria

patients in shock (defined as hypotension or shock index > 1 with oliguria, changed mental status and metabolic acidosis)
patients with a terminal illness on palliative care
patients with type 1 diabetes
patients with insulin pump therapy
patients with need for hospitalisation in the intensive or coronary care unit.
patients with presumed hospitalisation shorter than 48 hours
known pregnancy (in women with childbearing potential pregnancy test for exclusion mandatory)
no informed consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00353431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.