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Flexible Catheter for Insulin in Diabetes

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ClinicalTrials.gov Identifier: NCT03182569
Recruitment Status : Completed
First Posted : June 9, 2017
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetic Ketoacidosis Device: FLEXIBLE CATHETER Device: hourly rigid needle puncture Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of a Flexible Catheter for the Administration of Subcutaneous Insulin in Diabetic Ketoacidosis
Actual Study Start Date : December 11, 2016
Actual Primary Completion Date : April 9, 2018
Actual Study Completion Date : April 9, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Comfort measured by a visual analogue scale for pain [ Time Frame: 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 :
  1. Associated complications [ Time Frame: 24 hours ]
    complications associated with the insulin administration device (local infection, extravasation)

  2. Metabolic stability according to lab determinations [ Time Frame: between 10 to 14 hours ]
    Time to reach the metabolic stability defined by: glycemia ≤250 mg/dl, pH ≥ 7.3, bicarbonate ≥ 15 mmol/L);



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182569


Locations
Argentina
Hospital General de Niños Pedro de Elizalde
Buenos Aires, Constitucion, Argentina, C1270AAN
Sponsors and Collaborators
Hospital General de Niños Pedro de Elizalde
Investigators
Principal Investigator: Laura Beaudoin, MD Hospital General de Niños Pedro de Elizalde

Publications:
Responsible Party: Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier: NCT03182569     History of Changes
Other Study ID Numbers: HGNPE-247-2016
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Diabetic Ketoacidosis
Ketosis
Acidosis
Acid-Base Imbalance
Metabolic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Diabetes Complications
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs