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 number | NCT00353431 |
| Secondary identifying numbers | EKBB13/06 |
- 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
Scientific
Petersgraben 4
Basel
4031
Switzerland
| Phone | +41 (0)612 655 078 |
|---|---|
| ukeller@uhbs.ch |
Study information
| Study design | Interventional randomised open-label active-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Subcutaneous insulin |
| Primary outcome measure | 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). |
| Secondary outcome measures | 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) |
| Overall study start date | 31/08/2006 |
| Completion date | 30/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 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
4031
Switzerland
Sponsor information
University Hospital of Basel (Switzerland)
University/education
University/education
Petersgraben 4
Basel
4031
Switzerland
| Phone | +41 (0)612 655 078 |
|---|---|
| ukeller@uhbs.ch | |
| Website | http://www.endo-diabasel.ch |
"ROR" |
https://ror.org/04k51q396 |
Funders
Funder type
Industry
Novo Nordisk (Switzerland)
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Novo Nordisk Global
- Location
- Denmark
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | results | 14/06/2013 | 16/04/2019 | Yes | No |
Editorial Notes
16/04/2019: Publication reference and total final enrolment added.
