Flexible Catheter for Insulin in Diabetes

Hospital General de Niños Pedro de Elizalde

Status: Completed

Conditions: Diabetic Ketoacidosis

Treatments: Device: FLEXIBLE CATHETER; Device: hourly rigid needle puncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03182569

HGNPE-247-2016

Details and patient eligibility

About

Use of a flexible subcutaneous catheter improves comfort in patients with DKA compared to the usual treatment with a metal needle.

Full description

Assess whether the use of a flexible subcutaneous catheter improves comfort in patients with DKA compared to the usual treatment with a metal needle.

Compare the metabolic evolution of patients with DKA using a flexible subcutaneous catheter for insulin administration vs. a metal needle.

Enrollment: 20 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 5 to 18 years, admitted with diagnoses of DKA. DKA is defined when patients meets all the following biochemical baseline criteria (before initial hydration):
• Glucose> 200 mg / dl
• pH < 7.3
• Bicarbonate < 15mmol/l.

Exclusion criteria

• Patients referred from another institution with a different treatment, and those who requires intensive care on admission.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

flexible catheter

Experimental group

Description:

The flexible Subcutaneous catheter for insulin administration

Treatment:

Device: FLEXIBLE CATHETER

hourly rigid needle puncture

Active Comparator group

Description:

Hourly rigid needle puncture for Subcutaneous insulin administration

Treatment:

Device: hourly rigid needle puncture