Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/08/2007
Date assigned
03/09/2007
Last edited
03/09/2007
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 Armando Villegas-Jimenez

ORCID ID

Contact details

Direccion Medica
Vasco de Quiroga 15
Seccion XVI
Tlalpan
Mexico City
14000
Mexico
+52 55 56 55 90 68
armandov@quetzal.innsz.mx

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CIBH-1434

Study information

Scientific title

Acronym

COMETADIH

Study hypothesis

Type 2 Diabetes Mellitus (DM2) is the leading cause of death and the most common diagnosis in hospitalized patients in Mexico. The economic burden that DM2 imposes to the public health system is onerous. Strategies focused on improving medical care and optimising resources are of paramount importance.

In-patient hyperglycemia negatively affects related comorbidities and has been linked to negative outcomes when compared to strategies that attain good glycemic control. Traditional insulin sliding scales are still widely used to treat in-patient hyperglycemia, even though this approach has been questioned and at present time is not considered good clinical practice. Novel strategies must be explored and compared to traditional insulin sliding scales.

Hypothesis of this study: Glycemic control of in-patients can be improved by the implementation of standardised insulin protocols. Glycemic control achieved by standardised insulin protocols will be better compared to traditional insulin sliding scales.

Ethics approval

The Human Biomedical Research Institutional Committee (an internal regulatory organisation for clinical research and ethics) approved this trial on June 10th, 2005 (ref: 1434).

Study design

Single-centre, interventional, randomized, unblinded trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Type 2 Diabetes Mellitus

Intervention

Two general wards of a tertiary care hospital were randomly assigned to one of two standardised insulin protocols.

The two protocols consist of different proportions of intermediate and regular unmodified human insulin. One of the protocols was delivered in 4 daily injections and the other in 3. At initiation total daily insulin dose was calculated with the same guidelines for both protocols, further dose titration was provided according to pre-stablished glycemic goals and individual requirements.

Training was provieded to the nursing and medical staff and adherence to the protocol guidelines was supervised by the research team.

After inclusion to this study the patient was treated with the protocol assigned to the ward. Capillary Blood Glucose (CBG) was measured 4 times a day. Fasting Venous Blood Glucose (VBG) was measured according to the attending physician decision. All hypoglycemic episodes were registered in one of two categories:

1. Laboratory hypoglycemia (CBG <60 mg/dL)
2. Clinical hypoglycemia (Presence of adrenergic or neuroglycopenic symptoms with CBG >60 mg/dL that reverted after the ingestion of food)

Cause of the hypoglycemic episode was tracked and registered.

The patient was followed until discharge or until transfered to other areas such as the intensive care unit.

Glycemic control was compared in both protocols and, in a secondary analysis, the best protocol was compared with historical controls.

Intervention type

Drug

Phase

Not Specified

Drug names

insulin

Primary outcome measures

1. Mean CBG during study period
2. Mean VBG during study period
3. Hypoglycemic episodes

Secondary outcome measures

1. Clinical condition at the end of study period
2. Health team acceptance and adherence to the protocol guidelines
3. In-hospital morbidity and mortality registered during hospitalization

Overall trial start date

01/11/2005

Overall trial end date

30/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult hospitalized patients of any age or gender
2. Diabetes mellitus (World Health Organization criteria) and uncontrolled hyperglycemia on admission (capillary blood glucose >200 mg/dL or HbA1c >7.0)
3. Signed informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Forty five patients on each protocol. Al teast ninety patients overall.

Participant exclusion criteria

1. Good glycemic control on oral medication
2. Refusal to participate

Recruitment start date

01/11/2005

Recruitment end date

30/05/2006

Locations

Countries of recruitment

Mexico

Trial participating centre

Direccion Medica
Mexico City
14000
Mexico

Sponsor information

Organisation

The National Institute of Medical Sciences and Nutrition (Mexico)

Sponsor details

Vasco de Quiroga 15
Seccion XVI
Tlalpan
Mexico City
14000
Mexico
+52 55 54 87 09 00
acabral@quetzal.innsz.mx

Sponsor type

University/education

Website

http://www.innsz.mx

Funders

Funder type

Other

Funder name

This trial was funded by an unrestricted grant from institutional research budget of the National Institute of Medical Sciences and Nutrition (Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran). The National Institute of Medical Sciences and Nutrition is a non-profit organization, and its parental organizations are the Mexican Health Ministry (Secretaria de Salud de Mexico) and the Mexican National Autonomous University (Universidad Nacional Autonoma de Mexico). The National Institute of Medical Sciences and Nutrition is a tertiary care academic hospital.

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