Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Not specified
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
insulin
Primary outcome measure
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 study start date
01/11/2005
Overall study end date
30/05/2006
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|