Flexible Catheter for Insulin in Diabetes
Use of a Flexible Catheter for the Administration of Subcutaneous Insulin in Diabetic Ketoacidosis
1 other identifier
interventional
20
1 country
1
Brief Summary
Use of a flexible subcutaneous catheter improves comfort in patients with DKA compared to the usual treatment with a metal needle.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 11, 2016
CompletedFirst Submitted
Initial submission to the registry
March 14, 2017
CompletedFirst Posted
Study publicly available on registry
June 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2018
CompletedApril 12, 2018
April 1, 2018
1.3 years
March 14, 2017
April 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Associated complications
24 hours
Metabolic stability according to lab determinations
between 10 to 14 hours
Study Arms (2)
flexible catheter
EXPERIMENTALThe flexible Subcutaneous catheter for insulin administration
hourly rigid needle puncture
ACTIVE COMPARATORHourly rigid needle puncture for Subcutaneous insulin administration
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients referred from another institution with a different treatment, and those who requires intensive care on admission.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital General de Niños Pedro de Elizalde
Buenos Aires, Constitucion, C1270AAN, Argentina
Related Publications (2)
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.
PMID: 11953729BACKGROUNDBeaudoin 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.
PMID: 33687988DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Beaudoin, MD
Hospital General de Niños Pedro de Elizalde
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2017
First Posted
June 9, 2017
Study Start
December 11, 2016
Primary Completion
April 9, 2018
Study Completion
April 9, 2018
Last Updated
April 12, 2018
Record last verified: 2018-04