Condition category
Signs and Symptoms
Date applied
28/07/2009
Date assigned
23/09/2009
Last edited
23/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.conicyt.cl

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

Publication citations

Additional files

Editorial Notes