N/A
Completed N=130
Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia
Hyperglycemias
Source: ClinicalTrials.gov NCT00353431 ↗
Enrolled (actual)
130
Serious AEs
0.0%
Results posted
May 2012
Primary outcomePrimary: 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
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)
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 | — |
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
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. Informational only — not medical advice.