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Use of a flexible subcutaneous catheter improves comfort in patients with DKA compared to the usual treatment with a metal needle.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| flexible catheter | Experimental | The flexible Subcutaneous catheter for insulin administration |
|
| hourly rigid needle puncture | Active Comparator | Hourly rigid needle puncture for Subcutaneous insulin administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLEXIBLE CATHETER | Device |
| ||
| hourly rigid needle puncture |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort measured by a visual analogue scale for pain | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Associated complications | complications associated with the insulin administration device (local infection, extravasation) | 24 hours |
| Metabolic stability according to lab determinations | Time to reach the metabolic stability defined by: glycemia ≤250 mg/dl, pH ≥ 7.3, bicarbonate ≥ 15 mmol/L); |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Beaudoin, MD | Hospital General de Niños Pedro de Elizalde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Niños Pedro de Elizalde | Buenos Aires | Constitucion | C1270AAN | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11953729 | Background | 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. | |
| 33687988 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 6, 2025 | |
| Reset | Aug 22, 2025 | |
| Release | Sep 23, 2025 | |
| Reset | Oct 10, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 6, 2025 | Aug 22, 2025 | |||
| Sep 23, 2025 |
| ID | Term |
|---|---|
| D016883 | Diabetic Ketoacidosis |
| ID | Term |
|---|---|
| D007662 | Ketosis |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
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|
| between 10 to 14 hours |
| Beaudoin ML, Torrents M, Tittarelli MF, Hamui M, Ibarra M, Ferraro M, Ferreira JP. Use of a Flexible Catheter for the Administration of Subcutaneous Insulin in Diabetic Ketoacidosis: A Feasibility Controlled Clinical Trial. Hosp Pediatr. 2021 Apr;11(4):396-400. doi: 10.1542/hpeds.2020-0063. Epub 2021 Mar 9. |
| Oct 10, 2025 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |