Flexible Catheter for Insulin in Diabetes

April 11, 2018 updated by: Hospital General de Niños Pedro de Elizalde

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Constitucion
      • Buenos Aires, Constitucion, Argentina, C1270AAN
        • Hospital General de Niños Pedro de Elizalde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
between 10 to 14 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Associated complications
Time Frame: 24 hours
complications associated with the insulin administration device (local infection, extravasation)
24 hours
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);
between 10 to 14 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General de Niños Pedro de Elizalde

Investigators

  • Principal Investigator: Laura Beaudoin, MD, Hospital General de Niños Pedro de Elizalde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2016

Primary Completion (Actual)

April 9, 2018

Study Completion (Actual)

April 9, 2018

Study Registration Dates

First Submitted

March 14, 2017

First Submitted That Met QC Criteria

June 7, 2017

First Posted (Actual)

June 9, 2017

Study Record Updates

Last Update Posted (Actual)

April 12, 2018

Last Update Submitted That Met QC Criteria

April 11, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGNPE-247-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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