CompletedNCT03182569Updated Apr 12, 2018

Flexible Catheter for Insulin in Diabetes

An interventional study of FLEXIBLE CATHETER and hourly rigid needle puncture in Diabetic Ketoacidosis, sponsored by Hospital General de Niños Pedro de Elizalde. Completed at 1 site in Argentina. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-04-12.

Sponsored by Hospital General de Niños Pedro de Elizalde · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 3 months after the study started (first participant enrolled Dec 2016, registered Mar 2017).

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 5 Years to 18 Years
Sex: All

Study summary

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

Read the 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.

Conditions studied

Diabetic Ketoacidosis

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In context

Ketosis

181 studies on the registry are indexed under Ketosis; 37 are open to participants now.

This study's enrollment of 20 is below the median of 25 across 144 interventional studies indexed under Ketosis.

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Lead sponsor

Hospital General de Niños Pedro de Elizalde is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 5 Years to 18 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

Experimental
flexible catheter
The flexible Subcutaneous catheter for insulin administration
Device: FLEXIBLE CATHETER
Active comparator
hourly rigid needle puncture
Hourly rigid needle puncture for Subcutaneous insulin administration
Device: hourly rigid needle puncture

Interventions

DeviceFLEXIBLE CATHETER
Devicehourly rigid needle puncture

What researchers measure

Primary outcomes

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.
Time frame: between 10 to 14 hours

Secondary outcomes

Associated complications
complications associated with the insulin administration device (local infection, extravasation)
Time frame: 24 hours
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);
Time frame: between 10 to 14 hours

Study locations

1 site

Hospital General de Niños Pedro de Elizalde
Buenos Aires, Constitucion C1270AAN, Argentina

References and documents

Publications

Hanas R, Adolfsson P, Elfvin-Akesson K, Hammaren L, Ilvered R, Jansson I, Johansson C, Kroon M, Lindgren J, Lindh A, Ludvigsson J, Sigstrom 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. doi: 10.1067/mpd.2002.122470. Erratum In: J Pediatr 2002 Aug;141(2):298. Jansson, Iner [corrected to Jansson, Inger]; Wilk, Annica [corrected to Wiik, Annica]. PubMed 11953729 ↗
Beaudoin ML, Torrents M, Tittarelli MF, Hamui M, Ibarra M, Ferraro M, Ferreira JP. Use of a Flexible Catheter for the Administration of Subcutaneous Insulin in Diabetic Ketoacidosis: A Feasibility Controlled Clinical Trial. Hosp Pediatr. 2021 Apr;11(4):396-400. doi: 10.1542/hpeds.2020-0063. Epub 2021 Mar 9. PubMed 33687988 ↗

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03182569
Lead sponsor: Hospital General de Niños Pedro de Elizalde
Responsible party: Sponsor
First posted: Jun 9, 2017
Start date: Dec 11, 2016
Primary completion: Apr 9, 2018
Completion: Apr 9, 2018
Last update: Apr 12, 2018

Study contacts

Laura Beaudoin, MD

principal investigator · Hospital General de Niños Pedro de Elizalde

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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