Flexible Catheter for Insulin in Diabetes

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03182569

Enrollment

Registered

2017-06-09

Start date

2016-12-11

Completion date

2018-04-09

Last updated

2018-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Ketoacidosis

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.

Interventions

DEVICEFLEXIBLE CATHETER

DEVICEhourly rigid needle puncture

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Comfort measured by a visual analogue scale for pain	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

Measure	Time frame	Description
Associated complications	24 hours	complications associated with the insulin administration device (local infection, extravasation)
Metabolic stability according to lab determinations	between 10 to 14 hours	Time to reach the metabolic stability defined by: glycemia ≤250 mg/dl, pH ≥ 7.3, bicarbonate ≥ 15 mmol/L);

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026