Diabetic KetoacidosisNCT03182569
Flexible Catheter for Insulin in Diabetes
A study testing FLEXIBLE CATHETER and hourly rigid needle puncture in people with Diabetic Ketoacidosis, run by Hospital General de Niños Pedro de Elizalde at 1 site in Argentina.
Trial summary
Use of a flexible subcutaneous catheter improves comfort in patients with DKA compared to the usual treatment with a metal needle. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Diabetic Ketoacidosis
- What is being tested?
- FLEXIBLE CATHETER and hourly rigid needle puncture
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteArgentina
- Study dates
- 11 Dec 2016to 9 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Patients referred from another institution with a different treatment, and those who requires intensive care on admission.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital General de Niños Pedro de Elizalde
Buenos Aires, Constitucion, C1270AAN
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Ketoacidosis
- Being tested
- FLEXIBLE CATHETER, hourly rigid needle puncture
- Medical subject headings
- Diabetic Ketoacidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLEXIBLE CATHETERDevice
hourly rigid needle punctureDevice
| Study group | Role | What they receive |
|---|---|---|
| flexible catheter | Experimental | The flexible Subcutaneous catheter for insulin administration Receives: Device: FLEXIBLE CATHETER |
| hourly rigid needle puncture | Active comparator | Hourly rigid needle puncture for Subcutaneous insulin administration Receives: Device: hourly rigid needle puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: between 10 to 14 hours
Secondary outcomes (2)
Associated complications
complications associated with the insulin administration device (local infection, extravasation)
Measured: 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);
Measured: between 10 to 14 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start11 Dec 2016
- Primary completion9 Apr 2018
- Study completion9 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Niños Pedro de Elizalde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Beaudoin, MD, Principal investigator, Hospital General de Niños Pedro de Elizalde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182569
- Sponsor's protocol ID
- HGNPE-247-2016
- Status last verified
- Apr 2018
- First submitted
- 14 Mar 2017
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 11953729Beaudoin 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.
PubMed 33687988
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Flexible Catheter for the Administration of Subcutaneous Insulin in Diabetic Ketoacidosis
- ClinicalTrials.gov ID
- NCT03182569
- Acronym / sponsor ID
- HGNPE-247-2016
- Conditions
- Diabetic Ketoacidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital General de Niños Pedro de ElizaldeUniversity, hospital or other
- Study start
- 11 Dec 2016 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flexible catheter | Experimental | Device: FLEXIBLE CATHETERThe flexible Subcutaneous catheter for insulin administration |
| hourly rigid needle puncture | Active comparator | Device: hourly rigid needle punctureHourly rigid needle puncture for Subcutaneous insulin administration |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients referred from another institution with a different treatment, and those who requires intensive care on admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLEXIBLE CATHETER | Device | flexible catheter |
| hourly rigid needle puncture | Device | hourly rigid needle puncture |
Primary outcome
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.
2 secondary outcomes
Associated complications
Time frame: 24 hours
Metabolic stability according to lab determinations
Time frame: between 10 to 14 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Background: PubMed 11953729Hanas 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.
- Derived from this study: PubMed 33687988Beaudoin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Beaudoin, MD principal investigator
Hospital General de Niños Pedro de Elizalde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLEXIBLE CATHETER and hourly rigid needle puncture in people with Diabetic Ketoacidosis, run by Hospital General de Niños Pedro de Elizalde at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort measured by a visual analogue scale for pain (time frame: between 10 to 14 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03182569, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018; AzTrials last refreshed its copy on 31 Oct 2026.