Intensive versus conventional insulin therapy for inpatient medical patients [Insulinoterapia intensificada versus terapia habitual en pacientes hospitalizados por patología médica]
| ISRCTN | ISRCTN55845280 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55845280 |
| Secondary identifying numbers | SA08I20012 |
- Submission date
- 28/07/2009
- Registration date
- 23/09/2009
- Last edited
- 23/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Luis Rojas
Scientific
Scientific
Marcoleta 367
Quinto Piso
Santiago
-
Chile
| lrojas@med.puc.cl |
Study information
| Study design | Single centre randomised open trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non 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 | Intensive versus conventional insulin therapy for inpatient medical patients: a single centre randomised open trial |
| Study acronym | SUGAR-MINT |
| Study objectives | This trial will assess whether an adjustable insulin scheme which simulates the physiological secretion of this hormone is superior to standard treatment in medical inpatients with hyperglycaemia. |
| Ethics approval(s) | Ethics Committee of the Pontificia Universidad Católica de Chile (comité de ética de la Pontificia U. Católica de Chile) approved in December 2008 |
| Health condition(s) or problem(s) studied | Hyperglycaemia |
| Intervention | The project is based in the Universidad Católica de Chile Hospital, which is the main private facility of the Pontificia Universidad Católica de Chile, in Santiago, Chile. The clinical team in charge of insulin therapy is composed by internists, hospitalists and nurses. 1. Group 1: Intensive insulin therapy with basal NPH and nutritional regular insulin. Consisting of: 1.1. Two doses of basal NPH insulin, standardised according to weight and insulin resistance 1.2. Regular insulin (short-acting) prior to meals ("nutritional") both in fixed dose and through a sliding scale 2. Group 2: Intensive insulin therapy with basal glargine and nutritional regular insulin. Consisting of: 2.1. One dose of basal glargine insulin, standardized according to weight and insulin resistance 2.2. Regular insulin (short-acting) prior to meals ("nutritional") both in fixed dose and through a sliding scale 3. Group 3: Standard Care. Consisting of regular insulin four times a day (qid) or NPH twice daily (bid), according to a sliding scale. With the exception of insulin therapy, all other clinical decisions will be taken by the medical team in charge of the patient, which are independent from the research team. These include the administration of oral anti-diabetic drugs and the time of termination of insulin therapy. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Insulin |
| Primary outcome measure | Number of measurements of blood glucose levels between 70 and 130 mg/dl. All measurements will be recorded at day 7 and at the moment of discharge. |
| Secondary outcome measures | 1. Mean blood glucose level 2. Length of hospitalisation 3. Healthcare-associated infections 4. Number of measurements of blood glucose levels below 70 mg/dl 5. Time to achieve good glycaemic control (two or more measurements between 70 and 130 mg%) All measurements will be recorded at day 7 and at the moment of discharge. |
| Overall study start date | 01/03/2009 |
| Completion date | 01/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 250 |
| Key inclusion criteria | Adult inpatients (aged greater than 18 years, men and women) with an acute medical or surgical condition, and any of the following criteria: 1. In subjects known to have diabetes: Capillary blood glucose level over 180 mg/dl, in consecutive measurements separated by 2 hours, or just one measurement if insulin was administered after the first 2. In subjects without previous diagnosis of diabetes: Capillary blood glucose level over 200 mg/dl in consecutive measurements separated by 2 hours, or just one measurement if insulin was administered after the first |
| Key exclusion criteria | 1. Pregnancy 2. Acute complications of diabetes 3. Terminal illness (expected survival of less than a month) 4. Elective hospitalisation 5. Hospitalisation stay predicted to last less than 72 hours 6. Haemodyalisis initiated during hospitalisation 7. Peritoneal dialysis 8. Corticosteroids (prednisone) dose over 30 mg/day 9. Parenteral nutrition 10. Inability to receive carbohydrates by mouth for more than 8 hours 11. Patients with an unresolved surgical condition |
| Date of first enrolment | 01/03/2009 |
| Date of final enrolment | 01/06/2010 |
Locations
Countries of recruitment
- Chile
Study participating centre
Marcoleta 367
Santiago
-
Chile
-
Chile
Sponsor information
National Fund of Investigation and Development in Health (Fondo nacional de investigación y desarrollo en salud [FONIS]) (Chile)
Government
Government
Bernarda Morin 495
Providencia
Santiago
-
Chile
| fonis@conicyt.cl | |
| Website | http://www.conicyt.cl |
Funders
Funder type
Government
National Commission of Scientific Research and Technology, Ministry of Health (Chile) - Fifth National Contest of Projects of Investigation and Development in Health (FONIS 2008) (ref: SA08I20012)
No information available
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 |
