Back to resultsFlexible Catheter for Insulin in Diabetes
Primary Purpose
Diabetic Ketoacidosis
Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
FLEXIBLE CATHETER
hourly rigid needle puncture
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Ketoacidosis
Eligibility Criteria
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.
Sites / Locations
- Hospital General de Niños Pedro de Elizalde
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
flexible catheter
hourly rigid needle puncture
Arm Description
The flexible Subcutaneous catheter for insulin administration
Hourly rigid needle puncture for Subcutaneous insulin administration
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Associated complications
complications associated with the insulin administration device (local infection, extravasation)
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);
Full Information
NCT ID
NCT03182569
First Posted
March 14, 2017
Last Updated
April 11, 2018
Sponsor
Hospital General de Niños Pedro de Elizalde
1. Study Identification
Unique Protocol Identification Number
NCT03182569
Brief Title
Flexible Catheter for Insulin in Diabetes
Official Title
Use of a Flexible Catheter for the Administration of Subcutaneous Insulin in Diabetic Ketoacidosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 11, 2016 (Actual)
Primary Completion Date
April 9, 2018 (Actual)
Study Completion Date
April 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital General de Niños Pedro de Elizalde
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Ketoacidosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
flexible catheter
Arm Type
Experimental
Arm Description
The flexible Subcutaneous catheter for insulin administration
Arm Title
hourly rigid needle puncture
Arm Type
Active Comparator
Arm Description
Hourly rigid needle puncture for Subcutaneous insulin administration
Intervention Type
Device
Intervention Name(s)
FLEXIBLE CATHETER
Intervention Type
Device
Intervention Name(s)
hourly rigid needle puncture
Primary Outcome Measure Information:
Title
Comfort measured by a visual analogue scale for pain
Description
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 Outcome Measure Information:
Title
Associated complications
Description
complications associated with the insulin administration device (local infection, extravasation)
Time Frame
24 hours
Title
Metabolic stability according to lab determinations
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Beaudoin, MD
Organizational Affiliation
Hospital General de Niños Pedro de Elizalde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General de Niños Pedro de Elizalde
City
Buenos Aires
State/Province
Constitucion
ZIP/Postal Code
C1270AAN
Country
Argentina
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
11953729
Citation
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].
Results Reference
background
PubMed Identifier
33687988
Citation
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.
Results Reference
derived
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Flexible Catheter for Insulin in Diabetes
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