Flexible Catheter for Insulin in Diabetes

Diabetic Ketoacidosis Clinical Trial

Official title:

Use of a Flexible Catheter for the Administration of Subcutaneous Insulin in Diabetic Ketoacidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182569
• Other study ID #: HGNPE-247-2016
• Status: Completed
• Phase: N/A
• First received: March 14, 2017
• Last updated: April 11, 2018
• Start date: December 11, 2016
• Est. completion date: April 9, 2018

Study information

• Verified date: April 2018
• Source: Hospital General de Niños Pedro de Elizalde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 9, 2018
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Ketoacidosis
• Ketosis

Intervention

Device:
• FLEXIBLE CATHETER

• hourly rigid needle puncture

Locations

Country	Name	City	State
Argentina	Hospital General de Niños Pedro de Elizalde	Buenos Aires	Constitucion

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Niños Pedro de Elizalde

Country where clinical trial is conducted

Argentina, 

References & Publications (1)

Hanas R, Adolfsson P, Elfvin-Akesson K, Hammarén L, Ilvered R, Jansson I, Johansson C, Kroon M, Lindgren J, Lindh A, Ludvigsson J, Sigström L, Wiik A, Aman J. Indwelling catheters used from the onset of diabetes decrease injection pain and pre-injection anxiety. J Pediatr. 2002 Mar;140(3):315-20. Erratum in: J Pediatr 2002 Aug;141(2):298. Jansson, Iner [corrected to Jansson, Inger]; Wilk, Annica [corrected to Wiik, Annica]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort measured by a visual analogue scale for pain	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.	between 10 to 14 hours
Secondary	Associated complications	complications associated with the insulin administration device (local infection, extravasation)	24 hours
Secondary	Metabolic stability according to lab determinations	Time to reach the metabolic stability defined by: glycemia =250 mg/dl, pH = 7.3, bicarbonate = 15 mmol/L);	between 10 to 14 hours