Diabetic KetoacidosisNCT02930044
Early Subcutaneous Insulin Glargine Plus Standard of Care for Treatment of Diabetic Ketoacidosis
A study testing Early administration of subcutaneous insulin glargine dose, IV insulin infusion and IV fluid repletion in people with Diabetic Ketoacidosis, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of this study is to determine whether adult DKA patients who present to the emergency department treated with early subcutaneous long acting insulin versus standard care receive a shorter total duration of intravenous (IV) insulin infusion. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Diabetic Ketoacidosis
- What is being tested?
- Early administration of subcutaneous insulin glargine dose, IV insulin infusion and IV fluid repletion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 1 Nov 2021
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bicarbonate <18 mg/dL
- Anion gap >16
- Blood glucose >250 mg/dL
- Ketonemia or ketonuria
Who cannot join
- Pregnant women
- Refused consent
- Patient left ED against medical advice
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21217
About this study
Official title: Prospective Comparison of Early Subcutaneous Insulin Glargine Plus Standard of Care Versus Standard of Care for Treatment of Diabetic Ketoacidosis in the Emergency Department
The purpose of this study is to determine whether adult DKA patients who present to the emergency department treated with early subcutaneous long acting insulin versus standard care receive a shorter total duration of intravenous (IV) insulin infusion.
Read the detailed description
Specific Aims: To evaluate the impact of early administration of subcutaneous glargine versus standard care on time of insulin infusion in DKA patients and other secondary outcomes listed in this application.
Methods: DKA patients enrolled in this study will receive the long acting glargine dose (0.3 units/kg with a maximum dose of 30 units) within two hours after initiation the IV insulin infusion. Besides timing of the glargine dose, no other changes in standard patient care will occur in those patients enrolled in this study, the same labs will be collected and the insulin infusion will be titrated using the same hospital protocol algorithm.
Patients enrolled in the prospective arm will be compared with the retrospective control group, which received standard insulin therapy (subcutaneous insulin glargine administered at least 2 to 3 hours prior to termination of the insulin infusion). There will be 18 patients in this group selected in reverse chronological order from our pre-specified date range of 8/1/2014 to 7/31/2016.
- Conditions
- Diabetic Ketoacidosis
- Being tested
- Early administration of subcutaneous insulin glargine dose, IV insulin infusion, IV fluid repletion
- Keywords
- Emergency department, Insulin, Adult
- Medical subject headings
- Diabetic Ketoacidosis, Emergencies, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early administration of subcutaneous insulin glargine doseOther
DKA patients in the prospective intervention arm will receive subcutaneous glargine within two hours of starting their intravenous insulin infusion. The dose of glargine is 0.3 units/kg with a maximum dose of 30 units.
IV insulin infusionOther
All patients will receive the standard of care which is a protocol based continuous insulin infusion
IV fluid repletionDrug
0.9% NaCl or Plasmalyte A will be initiated as a continuous infusion for volume repletion. Fluids will be switched to contain potassium if serum potassium is less than 3.3 mEq/L. Fluids will be switched to contain dextrose if the serum glucose is less than 250 mg/dL.
| Study group | Role | What they receive |
|---|---|---|
| Early glargine dose | Experimental | Subcutaneous insulin glargine will be administered within two hours of starting the IV insulin infusion. Receives: Other: Early administration of subcutaneous insulin glargine dose; Other: IV insulin infusion; Drug: IV fluid repletion |
| Standard therapy | Placebo comparator | Retrospective arm that received standard insulin therapy for treatment of DKA Receives: Other: IV insulin infusion; Drug: IV fluid repletion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of intravenous insulin infusion
Measured in minutes from starting insulin infusion
Measured: up to 10 months
Secondary outcomes (7)
Time to resolution of high serum glucose (hyperglycemia)
Measured in minutes from starting insulin infusion
Measured: up to 10 months
Time to closure of anion gap
Measured in minutes from starting insulin infusion
Measured: up to 10 months
Time to correction of bicarbonate
Measured by serum bicarbonate
Measured: up to 10 months
Time to correction of serum pH
Measured by pH on venous blood gas
Measured: up to 10 months
Total duration of hospital stay
Measured in days
Measured: up to 10 months
Return of DKA within 24 hours
Indicated by presence of diagnostic criteria within 24 hours of starting insulin infusion
Measured: up to 10 months
Incidence of low serum glucose (hypoglycemia) within 24 hours
Measure by serum glucose.
Measured: up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Willis, University of Maryland, Baltimore
- Investigators
- George C Willis, MD, Principal investigator, Director of Undergraduate Medical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930044
- Sponsor's protocol ID
- HP-00070969
- Status last verified
- Mar 2022
- First submitted
- 14 Sep 2016
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual subject results will not be shared with those involved in the prospective arm.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Early Subcutaneous Insulin Glargine Plus Standard of Care Versus Standard of Care for Treatment of Diabetic Ketoacidosis in the Emergency Department
- ClinicalTrials.gov ID
- NCT02930044
- Acronym / sponsor ID
- HP-00070969
- Conditions
- Diabetic Ketoacidosis
- Keywords
- Emergency department, Insulin, Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 11 Oct 2016 (estimated)
- 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.
The purpose of this study is to determine whether adult DKA patients who present to the emergency department treated with early subcutaneous long acting insulin versus standard care receive a shorter total duration of intravenous (IV) insulin infusion.
Detailed description
Specific Aims: To evaluate the impact of early administration of subcutaneous glargine versus standard care on time of insulin infusion in DKA patients and other secondary outcomes listed in this application.
Methods: DKA patients enrolled in this study will receive the long acting glargine dose (0.3 units/kg with a maximum dose of 30 units) within two hours after initiation the IV insulin infusion. Besides timing of the glargine dose, no other changes in standard patient care will occur in those patients enrolled in this study, the same labs will be collected and the insulin infusion will be titrated using the same hospital protocol algorithm.
Patients enrolled in the prospective arm will be compared with the retrospective control group, which received standard insulin therapy (subcutaneous insulin glargine administered at least 2 to 3 hours prior to termination of the insulin infusion). There will be 18 patients in this group selected in reverse chronological order from our pre-specified date range of 8/1/2014 to 7/31/2016.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early glargine dose | Experimental | Other: Early administration of subcutaneous insulin glargine dose, Other: IV insulin infusion, Drug: IV fluid repletionSubcutaneous insulin glargine will be administered within two hours of starting the IV insulin infusion. |
| Standard therapy | Placebo comparator | Other: IV insulin infusion, Drug: IV fluid repletionRetrospective arm that received standard insulin therapy for treatment of DKA |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Bicarbonate <18 mg/dL
- Anion gap >16
- Blood glucose >250 mg/dL
- Ketonemia or ketonuria
Key exclusion criteria (3 listed)
- Pregnant women
- Refused consent
- Patient left ED against medical advice
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 |
|---|---|---|
| Early administration of subcutaneous insulin glargine doseDKA patients in the prospective intervention arm will receive subcutaneous glargine within two hours of starting their intravenous insulin infusion. The dose of glargine is 0.3 units/kg with a maximum dose of 30 units. | Other | Early glargine dose |
| IV insulin infusionAll patients will receive the standard of care which is a protocol based continuous insulin infusion | Other | Early glargine dose, Standard therapy |
| IV fluid repletion0.9% NaCl or Plasmalyte A will be initiated as a continuous infusion for volume repletion. Fluids will be switched to contain potassium if serum potassium is less than 3.3 mEq/L. Fluids will be switched to contain dextrose if the serum glucose is less than 250 mg/dL. | Drug | Early glargine dose, Standard therapy |
Primary outcome
Duration of intravenous insulin infusion
Time frame: up to 10 months
Measured in minutes from starting insulin infusion
7 secondary outcomes
Time to resolution of high serum glucose (hyperglycemia)
Time frame: up to 10 months
Time to closure of anion gap
Time frame: up to 10 months
Time to correction of bicarbonate
Time frame: up to 10 months
Time to correction of serum pH
Time frame: up to 10 months
Total duration of hospital stay
Time frame: up to 10 months
Return of DKA within 24 hours
Time frame: up to 10 months
Incidence of low serum glucose (hypoglycemia) within 24 hours
Time frame: up to 10 months
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 1 Apr 2022.
- Individual participant dataSharing planned: No. Individual subject results will not be shared with those involved in the prospective arm.
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Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)
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Perfusion Index for Predicting Diabetic Ketoacidosis Severity in the Emergency Department
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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.
George C Willis, MD principal investigator
Director of Undergraduate Medical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early administration of subcutaneous insulin glargine dose, IV insulin infusion and IV fluid repletion in people with Diabetic Ketoacidosis, run by University of Maryland, Baltimore 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 4 inclusion and 3 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 1 Apr 2022. 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?
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?
Duration of intravenous insulin infusion (time frame: up to 10 months). 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 1 Apr 2022.