Flexible Catheter for Insulin in Diabetes

Not Applicable

Completed

• Conditions: Diabetic Ketoacidosis
• Interventions: Device: FLEXIBLE CATHETER; Device: hourly rigid needle puncture

• Registration Number: NCT03182569
• Lead Sponsor: Hospital General de Niños Pedro de Elizalde

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-12-11
• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-06-07
• Study First Posted: 2017-06-09
• Status Verified: 2018-04
• Primary Completion: 2018-04-09
• Study Completion: 2018-04-09
• Last Update Submitted: 2018-04-11
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
flexible catheter	FLEXIBLE CATHETER	The flexible Subcutaneous catheter for insulin administration
hourly rigid needle puncture	hourly rigid needle puncture	Hourly rigid needle puncture for Subcutaneous insulin administration

Primary Outcome Measures

Name	Time	Method
Comfort measured by a visual analogue scale for pain	between 10 to 14 hours	Comfort measured by a visual analogue scale for pain (10cm = 0 meaning no pain and 10 meaning maximum pain) shown hourly after insulin administration until metabolic stability is achieved.

Secondary Outcome Measures

Name	Time	Method
Associated complications	24 hours	complications associated with the insulin administration device (local infection, extravasation)
Metabolic stability according to lab determinations	between 10 to 14 hours	Time to reach the metabolic stability defined by: glycemia ≤250 mg/dl, pH ≥ 7.3, bicarbonate ≥ 15 mmol/L);

Trial Locations

Locations (1)

Hospital General de Niños Pedro de Elizalde; 🇦🇷 Buenos Aires, Constitucion, Argentina