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Completed

NCT Number: NCT03182569

Flexible Catheter for Insulin in Diabetes

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

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Key information

Conditions

Diabetic Ketoacidosis Acid-Base Imbalance Acidosis Diabetes Complications Diabetes Mellitus Endocrine System Diseases Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General de Niños Pedro de Elizalde

Buenos Aires, Constitucion, C1270AAN, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FLEXIBLE CATHETER

Device

hourly rigid needle puncture

Device

Primary outcomes

  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 outcomes

  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);

Sponsors and collaborators

Lead sponsor

Hospital General de Niños Pedro de Elizalde

Other

Registry information

Official study title

Use of a Flexible Catheter for the Administration of Subcutaneous Insulin in Diabetic Ketoacidosis

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 9, 2017
Registry last updated
Apr 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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