Diabetic KetoacidosisNCT00179127
Use of Insulin Glargine to Treat Diabetic Ketoacidosis
A study testing glargine and saline in people with Diabetic Ketoacidosis, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of the addition of insulin glargine during the early phase of moderate to severe Diabetic Ketoacidosis (DKA) in children. The investigators hypothesize that the addition of insulin glargine during the early phase of management of DKA will accelerate acidosis… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Diabetic Ketoacidosis
- What is being tested?
- glargine and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 6-18 y.o. presenting to Vanderbilt Children's Hospital (VCH) Emergency Room with:
- Established history of insulin dependent diabetes
- AND:
- Chief c/o hyperglycemia or vomiting
- Venous pH < 7.24
- Serum Bicarbonate < 18
- Blood glucose > 150
- Urinary Ketones
Who cannot join
- Age < 6y.o.
- New onset diabetes
- Received IV insulin bolus prior to arrival to VCH Emergency Room (ER)
- Venous pH > 7.24
- Serum Bicarbonate > 18
- Pregnancy
- Received glargine within 12 hours prior to arrival to VCH Emergency Room/Pediatric Critical Care Unit
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Monroe Carell Children's Hospital
Nashville, Tennessee, 37232
About this study
Official title: Early Use of Insulin Glargine in Diabetic Ketoacidosis
The purpose of this study is to determine the effects of the addition of insulin glargine during the early phase of moderate to severe Diabetic Ketoacidosis (DKA) in children.
The investigators hypothesize that the addition of insulin glargine during the early phase of management of DKA will accelerate acidosis correction, decrease the length of insulin infusion, and decrease the total intensive care unit time in children admitted to the ICU.
- Conditions
- Diabetic Ketoacidosis
- Being tested
- glargine, saline
- Keywords
- Pediatrics, Diabetes, Emergency Care, Endocrinology, Critical Care
- Medical subject headings
- Diabetic Ketoacidosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glargineDrug
0.3u/kg of glargine, subcutaneously, once
salineDrug
0.3u/kg of saline, subcutaneously, once
| Study group | Role | What they receive |
|---|---|---|
| Glargine | Experimental | 0.3u/kg of glargine, subcutaneously, once Receives: Drug: glargine |
| Placebo | Placebo comparator | 0.3u/kg of saline, subcutaneously, once Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of Acidosis Correction
Unable to find any data on this study. PI left Vanderbilt and there was not a publication.
Measured: Minutes
Secondary outcomes (2)
Time on Insulin Drip
Unable to find any data on this study. PI left Vanderbilt and there was not a publication.
Measured: Minutes
Total Hospital Stay
Unable to find any data on this study. PI left Vanderbilt and there was not a publication.
Measured: Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionJul 2009
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheila McMorrow, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179127
- Sponsor's protocol ID
- 040643
- Status last verified
- Jun 2018
- First submitted
- 13 Sep 2005
- Last updated
- 16 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Use of Insulin Glargine in Diabetic Ketoacidosis
- ClinicalTrials.gov ID
- NCT00179127
- Acronym / sponsor ID
- 040643
- Conditions
- Diabetic Ketoacidosis
- Keywords
- Pediatrics, Diabetes, Emergency Care, Endocrinology, Critical Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 16 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of the addition of insulin glargine during the early phase of moderate to severe Diabetic Ketoacidosis (DKA) in children.
The investigators hypothesize that the addition of insulin glargine during the early phase of management of DKA will accelerate acidosis correction, decrease the length of insulin infusion, and decrease the total intensive care unit time in children admitted to the ICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glargine | Experimental | Drug: glargine0.3u/kg of glargine, subcutaneously, once |
| Placebo | Placebo comparator | Drug: saline0.3u/kg of saline, subcutaneously, once |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Ages 6-18 y.o. presenting to Vanderbilt Children's Hospital (VCH) Emergency Room with:
- Established history of insulin dependent diabetes
- Chief c/o hyperglycemia or vomiting
- Venous pH < 7.24
- Serum Bicarbonate < 18
Key exclusion criteria (7 listed)
- Age < 6y.o.
- New onset diabetes
- Received IV insulin bolus prior to arrival to VCH Emergency Room (ER)
- Venous pH > 7.24
- Serum Bicarbonate > 18
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 |
|---|---|---|
| glargine0.3u/kg of glargine, subcutaneously, once | Drug | Glargine |
| saline0.3u/kg of saline, subcutaneously, once | Drug | Placebo |
Primary outcome
Time of Acidosis Correction
Time frame: Minutes
Unable to find any data on this study. PI left Vanderbilt and there was not a publication.
2 secondary outcomes
Time on Insulin Drip
Time frame: Minutes
Total Hospital Stay
Time frame: Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sheila McMorrow, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glargine and saline in people with Diabetic Ketoacidosis, run by Vanderbilt University Medical Center at 1 site in United States.
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 8 inclusion and 7 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 16 Jul 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 16 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time of Acidosis Correction (time frame: Minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2018.