Evaluation of an algorithm for intensive subcutaneous insulin therapy in emergency room patients with hyperglycaemia

ISRCTN	ISRCTN55224894
DOI	https://doi.org/10.1186/ISRCTN55224894
ClinicalTrials.gov (NCT)	NCT00353431
Protocol serial number	EKBB13/06
Sponsor	University Hospital of Basel (Switzerland)
Funder	Novo Nordisk (Switzerland)

Submission date: 17/07/2006
Registration date: 17/08/2006
Last edited: 16/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ulrich Keller
Scientific

Petersgraben 4
Basel
4031
Switzerland

Phone	+41 (0)612 655 078
Email	ukeller@uhbs.ch

Study information

Primary study design	Interventional
Study design	Interventional randomised open-label active-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluation of an algorithm for intensive subcutaneous insulin therapy in emergency room patients with hyperglycaemia
Study acronym	Euglycemia
Study objectives	Time in the glycaemic target range (5.5 to 7.0 mmol/l) during the period of observation of 48 hours expected to be longer in the intensive insulin group.
Ethics approval(s)	Local Ethics Committee of Basel, Switzerland (EKBB) approval, 20/03/2006, ref: 13/06
Health condition(s) or problem(s) studied	All medical patients with a plasma glucose concentration more than 8 mmol/l
Intervention	Comparison of a normal sliding scale with subcutaneous (s.c.) insulin injections versuss the new algorithm with s.c. insulin injections (in both groups NovoRapid ®)
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Subcutaneous insulin
Primary outcome measure(s)	Time in the glycaemic target range (5.5 to 7.0 mmol/l) during the period of observation of 48 hours (expected to be longer in the intensive insulin group).
Key secondary outcome measure(s)	1. Time to reach the target range (expected to be shorter in the intensive insulin group) 2. Frequency of hypoglycaemia (plasma glucose less than 3.8 mmol/l) (safety endpoint, expected to be similar in the two groups) 3. Frequency of severe hypoglycaemia (plasma glucose less than 2.5 mmol/l) (safety endpoint, expected to be similar in the two groups) 4. Frequency of hypokalaemia (safety endpoint, expected to be similar in the two groups)
Completion date	30/04/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	140
Total final enrolment	130
Key inclusion criteria	1. All patients with hyperglycaemia (more than 8.0 mmol/l) admitted to the medical emergency room 2. Patients with presumed hospitalisation in the Emergency Room (ER) or medical ward of more than 48 hours duration
Key exclusion criteria	1. Patients in shock (defined as hypotension or shock index more than one with oliguria, changed mental status and metabolic acidosis) 2. Patients with a terminal illness on palliative care 3. Patients with type one diabetes 4. Patients with insulin pump therapy 5. Patients with need for hospitalisation in the intensive or coronary care unit 6. Patients with presumed hospitalisation shorter than 48 hours 7. Known pregnancy (in women of birthbearing age pregnancy test for exclusion mandatory) 8. No informed consent
Date of first enrolment	31/08/2006
Date of final enrolment	30/04/2008

Locations

Countries of recruitment

Switzerland

Study participating centre

Petersgraben 4

Basel
4031
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/06/2013	16/04/2019	Yes	No
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

16/04/2019: Publication reference and total final enrolment added.