DiabetesDOSE-HDNCT02083133
Insulin Dosing in Diabetic Patients With End Stage Renal Disease (ESRD) or Hemodialysis
An observational study of Diabetes and Hypoglycemia, run by Cook County Health at 1 site in United States.
Trial summary
The purpose of this study is to assess whether the current recommendation for a 50% dose reduction in insulin for diabetic patients with a creatinine clearance (CrCl) ≤15 mL/min or on hemodialysis results in an increased number of hypoglycemic episodes. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetes, Hypoglycemia, Renal Dysfunction
- How many people
- 496 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2013to 17 May 2017
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In patient hospitalized greater than or equal to three days, diabetic with CKD 3-5 or on dialysis on insulin therapy
Who may be able to join
- Inpatient men and women 18 years of age and older with a diagnosis of type 2 diabetes mellitus (T2DM) with CrCl ≥60, 16-59 or ≤15 milliliters/minute.
Who cannot join
- Patients less than 18 years of age, pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
John H Stroger Hospital of Cook County
Chicago, Illinois, 60612
About this study
Official title: Dosing Strategies in Diabetic Patients With End Stage Renal Disease (ESRD) or Hemodialysis (DOSE-HD Study)
The purpose of this study is to assess whether the current recommendation for a 50% dose reduction in insulin for diabetic patients with a creatinine clearance (CrCl) ≤15 mL/min or on hemodialysis results in an increased number of hypoglycemic episodes.
- Conditions
- Diabetes, Hypoglycemia, Renal Dysfunction, Insulin Dosing
- Keywords
- Diabetes, Renal Failure, Dialysis, End Stage Renal Disease, Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia, Renal Insufficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| End Stage Renal Disease | GFR 15 ml/min or less or on Dialysis | |
| Chronic Kidney Disease Stage 4 | GFR 15-30 ml/min | |
| Chronic Kidney Disease Stage -3 | GFR 30-60 ml/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia
Measured: Last 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study start1 Oct 2013
- Primary completion15 Jan 2017
- Study completion17 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pete Antonopoulos, Cook County Health
- Investigators
- Pete Antonopoulos, PharmD, Principal investigator, Cook County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083133
- Sponsor's protocol ID
- 13-188
- Acronym
- DOSE-HD
- Status last verified
- Jun 2023
- First submitted
- 7 Mar 2014
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosing Strategies in Diabetic Patients With End Stage Renal Disease (ESRD) or Hemodialysis (DOSE-HD Study)
- ClinicalTrials.gov ID
- NCT02083133
- Acronym / sponsor ID
- DOSE-HD / 13-188
- Conditions
- Diabetes, Hypoglycemia, Renal Dysfunction, Insulin Dosing
- Keywords
- Diabetes, Renal Failure, Dialysis, End Stage Renal Disease, Hypoglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 496 participants (actual)
- Lead sponsor
- Cook County HealthOther government
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 15 Jan 2017 (actual)
- Study completion
- 17 May 2017 (actual)
- First posted
- 11 Mar 2014 (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 assess whether the current recommendation for a 50% dose reduction in insulin for diabetic patients with a creatinine clearance (CrCl) ≤15 mL/min or on hemodialysis results in an increased number of hypoglycemic episodes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| End Stage Renal Disease | – | –GFR 15 ml/min or less or on Dialysis |
| Chronic Kidney Disease Stage 4 | – | –GFR 15-30 ml/min |
| Chronic Kidney Disease Stage -3 | – | –GFR 30-60 ml/min |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In patient hospitalized greater than or equal to three days, diabetic with CKD 3-5 or on dialysis on insulin therapy
Key inclusion criteria (1 listed)
- Inpatient men and women 18 years of age and older with a diagnosis of type 2 diabetes mellitus (T2DM) with CrCl ≥60, 16-59 or ≤15 milliliters/minute.
Key exclusion criteria (1 listed)
- Patients less than 18 years of age, pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hypoglycemia
Time frame: Last 5 years
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 22 Jun 2023.
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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.
Pete Antonopoulos, PharmD principal investigator
Cook County Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Hypoglycemia, run by Cook County Health 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 1 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 22 Jun 2023. 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?
Hypoglycemia (time frame: Last 5 years). 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 22 Jun 2023.