HyperglycemiaNCT02478190
ED Management of Severe Hyperglycemia: A Clinical Trial
A study of Hyperglycemia and Diabetes Mellitus, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial summary
Emergency Department (ED) patients with severe hyperglycemia will be randomized to two treatment goals: discharge glucose less than 600 mg/dL or less than 350 mg/dL. Randomization is stratified by whether the chief complaint is "High Blood Sugar" in the electronic medical record or other. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia, Diabetes Mellitus, Complications of Diabetes Mellitus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glucose of more than 400mg/dL but less than 600 mg/dL at any point in the ED
- Working phone number and willing to discuss health status at 7-10 days via phone
Who cannot join
- Plan for hospital admission
- Already received insulin during the ED stay
- Type 1 diabetes
- Less than 18 years old
- Non-English speaking
- Altered mental status or encephalopathy (unable to provide informed consent)
Show all 11Show fewer
- DKA, as determined clinically by the treating physician, without a lab requirement.
- Critically ill, as determined by the treating physician.
- Unable to provide informed consent
- Prisoners
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
Official title: ED Management of Severe Hyperglycemia: An Open-Label Randomized Clinical Trial
Emergency Department (ED) patients with severe hyperglycemia will be randomized to two treatment goals: discharge glucose less than 600 mg/dL or less than 350 mg/dL.
Randomization is stratified by whether the chief complaint is "High Blood Sugar" in the electronic medical record or other.
Read the detailed description
It is common practice to provide insulin and/or intravenous (IV) fluids to lower glucose levels prior to discharge in patients that present with hyperglycemia. There is, however, no data supporting this practice.
A recent retrospective observational cohort study (HSR# 12-3497) of 567 ED patients with severe hyperglycemia demonstrated no association between discharge glucose levels and short-term adverse outcomes at 7 days (return ED visits, diabetic ketoacidosis (DKA), hospitalization, and death).
There were no other short-term adverse outcomes associated with the degree of glycemic control. Less than 1% of patients developed DKA at 7 days. No patients died.
As this was a retrospective study, the conclusions that can be drawn are limited by the lack of randomization and control; it is necessary to conduct a randomized controlled trial to quantify how much time is expended caring for these patients, and gather safety data.
This is important because much time and money is focused on glucose reduction, which may not change short-term outcomes. Furthermore, in retrospective analysis approximately 1.5% of patients receiving therapy for hyperglycemia developed iatrogenic hypoglycemia during the ED stay.
To detect a difference in length of stay by 60 minutes (Standard deviation is 100 minutes) with an p=0.05 and b=0.8, enrollment of 45 patients per group will be required, with a total enrollment of 90 patients. Enrollment will stop when 45 patients in each group have been contacted in follow-up.
This study will only include patients who are discharged from the ED. Patients who are enrolled and then eventually admitted to the hospital will be tabulated but excluded from the length of stay analysis.
Statistical analysis will be completed for the primary outcome with a Mann-Whitney U test, assuming the data will not be normally distributed. Secondary outcomes will be compared with chi-squared testing. A secondary regression model will be formed, based on covariates that could influence ED length of stay, such as amount of diagnostic testing completed.
- Conditions
- Hyperglycemia, Diabetes Mellitus, Complications of Diabetes Mellitus, Diabetes-Related Complications, Diabetes Mellitus, Type 2
- Being tested
- Tight control: goal glucose 350 mg/dL or lower, Loose control: goal glucose 600 mg/dL or lower
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus, Diabetes Complications, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tight control: goal glucose 350 mg/dL or lowerOther
Goal glucose at discharge will be 350 mg/dL or less.
Loose control: goal glucose 600 mg/dL or lowerOther
Goal glucose at discharge will be 600 mg/dL or less.
| Study group | Role | What they receive |
|---|---|---|
| Tight control | Experimental | Patients in this arm will have a treatment glucose value at ED discharge of 350 mg/dL or lower. Receives: Other: Tight control: goal glucose 350 mg/dL or lower |
| Loose control | Experimental | Patients in this arm will have a treatment glucose value at ED discharge of 600 mg/dL or lower. Receives: Other: Loose control: goal glucose 600 mg/dL or lower |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED Length of Stay
Time elapsed from when the patient is roomed until the time the MD places discharge order, by review of the Electronic Medical record by a blinded abstractor.
Measured: This outcome measure is defined as the amount of time elapsed between when the patient is roomed, and when a discharge order is placed, during a single ED encounter, which is generally less than 4 hours.
Secondary outcomes (3)
Iatrogenic hypoglycemia
Rate of iatrogenic hypoglycemia in both groups, defined as: glucose <60 or glucose less than 100 mg/dL and symptoms of hypoglycemia that resolved with food/drink, or any use of IV dextrose 50%, glucagon, or oral glucose tabs/gel
Measured: The patient will be followed during a single ED encounter, which is generally less than 4 hours.
Return ED visit for hyperglycemia and hospital admission for any reason, excluding trauma
Composite outcome of rate of repeat ED visit for hyperglycemia or hospital admission for any reason, excluding trauma admission. ED visit for hyperglycemia defined as: chief complaint of hyperglycemia, chief complaint of polyuria, polydipsia, fatigue, blurry vision, or malaise and found to have blood glucose more than 250 mg/dL, primary ED diagnosis of hyperglycemia, or ED or hospital diagnosis of DKA or hyperosmolar syndrome.
Measured: 7 days
Return ED visit for any reason
Each patient will be assessed via chart review and telephone follow up to see if they visited an ED for any reason during the 7 day time frame. Rates of ED visits for any reason at 7 days will be compared between the two treatment arms.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Driver, Hennepin Healthcare Research Institute
- Investigators
- Brian Driver, MD, Principal investigator, HCMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478190
- Sponsor's protocol ID
- 15-3931
- Status last verified
- Mar 2018
- First submitted
- 17 Jun 2015
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Driver BE, Klein LR, Cole JB, Prekker ME, Fagerstrom ET, Miner JR. Comparison of two glycemic discharge goals in ED patients with hyperglycemia, a randomized trial. Am J Emerg Med. 2019 Jul;37(7):1295-1300. doi: 10.1016/j.ajem.2018.09.053. Epub 2018 Oct 5.
PubMed 30316635
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ED Management of Severe Hyperglycemia: An Open-Label Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02478190
- Acronym / sponsor ID
- 15-3931
- Conditions
- Hyperglycemia, Diabetes Mellitus, Complications of Diabetes Mellitus, Diabetes-Related Complications, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 23 Jun 2015 (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.
Emergency Department (ED) patients with severe hyperglycemia will be randomized to two treatment goals: discharge glucose less than 600 mg/dL or less than 350 mg/dL.
Randomization is stratified by whether the chief complaint is "High Blood Sugar" in the electronic medical record or other.
Detailed description
It is common practice to provide insulin and/or intravenous (IV) fluids to lower glucose levels prior to discharge in patients that present with hyperglycemia. There is, however, no data supporting this practice.
A recent retrospective observational cohort study (HSR# 12-3497) of 567 ED patients with severe hyperglycemia demonstrated no association between discharge glucose levels and short-term adverse outcomes at 7 days (return ED visits, diabetic ketoacidosis (DKA), hospitalization, and death).
There were no other short-term adverse outcomes associated with the degree of glycemic control. Less than 1% of patients developed DKA at 7 days. No patients died.
As this was a retrospective study, the conclusions that can be drawn are limited by the lack of randomization and control; it is necessary to conduct a randomized controlled trial to quantify how much time is expended caring for these patients, and gather safety data.
This is important because much time and money is focused on glucose reduction, which may not change short-term outcomes. Furthermore, in retrospective analysis approximately 1.5% of patients receiving therapy for hyperglycemia developed iatrogenic hypoglycemia during the ED stay.
To detect a difference in length of stay by 60 minutes (Standard deviation is 100 minutes) with an p=0.05 and b=0.8, enrollment of 45 patients per group will be required, with a total enrollment of 90 patients. Enrollment will stop when 45 patients in each group have been contacted in follow-up.
This study will only include patients who are discharged from the ED. Patients who are enrolled and then eventually admitted to the hospital will be tabulated but excluded from the length of stay analysis.
Statistical analysis will be completed for the primary outcome with a Mann-Whitney U test, assuming the data will not be normally distributed. Secondary outcomes will be compared with chi-squared testing. A secondary regression model will be formed, based on covariates that could influence ED length of stay, such as amount of diagnostic testing completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tight control | Experimental | Other: Tight control: goal glucose 350 mg/dL or lowerPatients in this arm will have a treatment glucose value at ED discharge of 350 mg/dL or lower. |
| Loose control | Experimental | Other: Loose control: goal glucose 600 mg/dL or lowerPatients in this arm will have a treatment glucose value at ED discharge of 600 mg/dL or lower. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Glucose of more than 400mg/dL but less than 600 mg/dL at any point in the ED
- Working phone number and willing to discuss health status at 7-10 days via phone
Key exclusion criteria (11 listed)
- Plan for hospital admission
- Already received insulin during the ED stay
- Type 1 diabetes
- Less than 18 years old
- Non-English speaking
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 |
|---|---|---|
| Tight control: goal glucose 350 mg/dL or lowerGoal glucose at discharge will be 350 mg/dL or less. | Other | Tight control |
| Loose control: goal glucose 600 mg/dL or lowerGoal glucose at discharge will be 600 mg/dL or less. | Other | Loose control |
Primary outcome
ED Length of Stay
Time frame: This outcome measure is defined as the amount of time elapsed between when the patient is roomed, and when a discharge order is placed, during a single ED encounter, which is generally less than 4 hours.
Time elapsed from when the patient is roomed until the time the MD places discharge order, by review of the Electronic Medical record by a blinded abstractor.
3 secondary outcomes
Iatrogenic hypoglycemia
Time frame: The patient will be followed during a single ED encounter, which is generally less than 4 hours.
Return ED visit for hyperglycemia and hospital admission for any reason, excluding trauma
Time frame: 7 days
Return ED visit for any reason
Time frame: 7 days
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 21 Mar 2018.
- Derived from this study: PubMed 30316635Driver BE, Klein LR, Cole JB, Prekker ME, Fagerstrom ET, Miner JR. Comparison of two glycemic discharge goals in ED patients with hyperglycemia, a randomized trial. Am J Emerg Med. 2019 Jul;37(7):1295-1300. doi: 10.1016/j.ajem.2018.09.053. Epub 2018 Oct 5.
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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.
Brian Driver, MD principal investigator
HCMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hyperglycemia and Diabetes Mellitus, run by Hennepin Healthcare Research Institute 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 2 inclusion and 11 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 21 Mar 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. 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?
ED Length of Stay (time frame: This outcome measure is defined as the amount of time elapsed between when the patient is roomed, and when a discharge order is placed, during a single ED encounter, which is generally less than 4 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 NCT02478190, which also lists 1 linked publication.
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 21 Mar 2018.