Contact information
Type
Scientific
Primary contact
Dr Luis Rojas
ORCID ID
Contact details
Marcoleta 367
Quinto Piso
Santiago
-
Chile
lrojas@med.puc.cl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SA08I20012
Study information
Scientific title
Intensive versus conventional insulin therapy for inpatient medical patients: a single centre randomised open trial
Acronym
SUGAR-MINT
Study hypothesis
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
Ethics Committee of the Pontificia Universidad Católica de Chile (comité de ética de la Pontificia U. Católica de Chile) approved in December 2008
Study design
Single centre randomised open trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase IV
Drug names
Insulin
Primary outcome measures
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 trial start date
01/03/2009
Overall trial end date
01/06/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Participant 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
Recruitment start date
01/03/2009
Recruitment end date
01/06/2010
Locations
Countries of recruitment
Chile
Trial participating centre
Marcoleta 367
Santiago
-
Chile
Sponsor information
Organisation
National Fund of Investigation and Development in Health (Fondo nacional de investigación y desarrollo en salud [FONIS]) (Chile)
Sponsor details
Bernarda Morin 495
Providencia
Santiago
-
Chile
fonis@conicyt.cl
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
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)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary