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
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Ketoacidosis||Device: FLEXIBLE CATHETER Device: hourly rigid needle puncture||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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);
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
|Hospital General de Niños Pedro de Elizalde|
|Buenos Aires, Constitucion, Argentina, C1270AAN|
|Principal Investigator:||Laura Beaudoin, MD||Hospital General de Niños Pedro de Elizalde|