Flexible Catheter for Insulin in Diabetes

Overview

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

Full Title of Study: “Use of a Flexible Catheter for the Administration of Subcutaneous Insulin in Diabetic Ketoacidosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 9, 2018

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.

Interventions

  • Device: FLEXIBLE CATHETER
  • Device: hourly rigid needle puncture

Arms, Groups and Cohorts

  • Experimental: flexible catheter
    • The flexible Subcutaneous catheter for insulin administration
  • Active Comparator: hourly rigid needle puncture
    • Hourly rigid needle puncture for Subcutaneous insulin administration

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Associated complications
    • Time Frame: 24 hours
    • complications associated with the insulin administration device (local infection, extravasation)
  • 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);

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital General de Niños Pedro de Elizalde
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Laura Beaudoin, MD, Principal Investigator, Hospital General de Niños Pedro de Elizalde

References

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].

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