Diabetes Mellitus, Type 2NCT02868606
Physiologic Insulin Therapy for the Management of Hyperglycemia in the Hospital
An observational study of Diabetes Mellitus, Type 2 and Hyperglycemia, run by Winthrop University Hospital at 1 site in United States.
Trial summary
Many hospitals have begun giving insulin to nearly all patients with diabetes while they are in the hospital even if a patient does not use insulin at home. Controlling blood sugar with insulin when a patient is hospitalized is believed to reduce the risk of complications and death, but research has not demonstrated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hyperglycemia
- What is being tested?
- Physiologic Insulin Therapy and Sliding-Scale Insulin Therapy
- How many people
- 40,391 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 30 Jun 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients with type 2 diabetes mellitus admitted to a medical or surgical service
Who may be able to join
- Type 2 diabetes
Who cannot join
- Pregnant
- Admitted directly to an intensive care unit
- Length of stay <2 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop-University Hospital
Mineola, New York, 11501
About this study
Many hospitals have begun giving insulin to nearly all patients with diabetes while they are in the hospital even if a patient does not use insulin at home. Controlling blood sugar with insulin when a patient is hospitalized is believed to reduce the risk of complications and death, but research has not demonstrated these benefits except in patients who are critically ill. The purpose of this study, therefore, is to evaluate whether such insulin therapy actually does reduce in-hospital complications, deaths, need for intensive care, or length of stay in the hospital.
Read the detailed description
The primary aim of the proposed study is to determine if physiologic insulin therapy administered to general hospital inpatients with hyperglycemia favorably affects in-hospital complications and mortality, need for intensive care, or length of stay. The secondary aim is to determine if the magnitude of benefit derived from this therapy differs (a) in patients with known vs. newly diagnosed diabetes, or (b) in medical vs. surgical patients. The study will analyze data from a natural experiment that occurred when the applicant institution introduced universal physiologic insulin therapy as the standard of care for hyperglycemia. A quasi-experimental before-and-after study will compare in-hospital complications, mortality, and resource use in patients with comorbid type 2 diabetes before vs. after implementation of this standard (n≈6400). Outcomes measured at 7 nearby acute-care teaching hospitals during the same two time intervals will provide parallel control data (n≈35,000). Data from the control hospitals will make it possible to evaluate whether temporal changes in patient characteristics or other variables affecting hospitals in the region could explain effects that might otherwise be erroneously attributed to the intervention. Given the high prevalence of comorbid diabetes in the hospital and the possibility that universal physiologic insulin for managing hyperglycemia may not deliver the intended benefit or could even do more harm than good, answering this question is an important goal.
- Conditions
- Diabetes Mellitus, Type 2, Hyperglycemia
- Being tested
- Physiologic Insulin Therapy, Sliding-Scale Insulin Therapy
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiologic Insulin TherapyOther
Sliding-Scale Insulin TherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Historical control group (H) | Winthrop patients with diabetes hospitalized between August 1, 2010 and March 31, 2011 Receives: Other: Sliding-Scale Insulin Therapy | |
| Intervention group (I) | Winthrop patients with diabetes hospitalized between August 1, 2011 and March 31, 2012 Receives: Other: Physiologic Insulin Therapy | |
| Parallel control group (P-sub-H) | Patients with diabetes hospitalized between August 1, 2010 and March 31, 2011 at 7 control hospitals located in the New York City metropolitan region Receives: Other: Sliding-Scale Insulin Therapy | |
| Parallel control group (I-sub-H) | Patients with diabetes hospitalized between August 1, 2011 and March 31, 2012 at 7 control hospitals located in the New York City metropolitan region Receives: Other: Sliding-Scale Insulin Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfer to intensive care unit (y/n)
Assigned "y" if patient is transferred to an intensive care unit for any length of time; otherwise, assigned "n".
Measured: Upon hospital discharge (median length of stay, 5 days)
Secondary outcomes (7)
Day-weighted proportion of blood glucose values within target range (100-180 mg/dL)
Measured: Upon hospital discharge (median length of stay, 5 days)
Proportion of inpatient days involving any hypoglycemia (blood glucose<70 mg/dL)
Measured: Upon hospital discharge (median length of stay, 5 days)
Proportion of inpatient days involving severe hypoglycemia (blood glucose<40 mg/dL)
Measured: Upon hospital discharge (median length of stay, 5 days)
Proportion of inpatient days involving any hyperglycemia (blood glucose>200 mg/dL)
Measured: Upon hospital discharge (median length of stay, 5 days)
Proportion of inpatient days involving severe hyperglycemia (blood glucose>300 mg/dL)
Measured: Upon hospital discharge (median length of stay, 5 days)
Development of any complication (y/n)
Measured: Upon hospital discharge (median length of stay, 5 days)
In-hospital death (y/n)
Measured: Upon hospital discharge (median length of stay, 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startJul 2015
- Primary completion15 Aug 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 40,391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donald Brand, PhD, Winthrop University Hospital
- Investigators
- Donald A Brand, Ph.D., Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868606
- Sponsor's protocol ID
- 756440-2
- Other IDs
- R18DK104110
- Status last verified
- Jun 2019
- First submitted
- 29 Jul 2016
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Insulin Therapy for the Management of Hyperglycemia in the Hospital
- ClinicalTrials.gov ID
- NCT02868606
- Acronym / sponsor ID
- 756440-2
- Conditions
- Diabetes Mellitus, Type 2, Hyperglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40,391 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2015
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 16 Aug 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.
Many hospitals have begun giving insulin to nearly all patients with diabetes while they are in the hospital even if a patient does not use insulin at home. Controlling blood sugar with insulin when a patient is hospitalized is believed to reduce the risk of complications and death, but research has not demonstrated these benefits except in patients who are critically ill. The purpose of this study, therefore, is to evaluate whether such insulin therapy actually does reduce in-hospital complications, deaths, need for intensive care, or length of stay in the hospital.
Detailed description
The primary aim of the proposed study is to determine if physiologic insulin therapy administered to general hospital inpatients with hyperglycemia favorably affects in-hospital complications and mortality, need for intensive care, or length of stay. The secondary aim is to determine if the magnitude of benefit derived from this therapy differs (a) in patients with known vs. newly diagnosed diabetes, or (b) in medical vs. surgical patients. The study will analyze data from a natural experiment that occurred when the applicant institution introduced universal physiologic insulin therapy as the standard of care for hyperglycemia. A quasi-experimental before-and-after study will compare in-hospital complications, mortality, and resource use in patients with comorbid type 2 diabetes before vs. after implementation of this standard (n≈6400). Outcomes measured at 7 nearby acute-care teaching hospitals during the same two time intervals will provide parallel control data (n≈35,000). Data from the control hospitals will make it possible to evaluate whether temporal changes in patient characteristics or other variables affecting hospitals in the region could explain effects that might otherwise be erroneously attributed to the intervention. Given the high prevalence of comorbid diabetes in the hospital and the possibility that universal physiologic insulin for managing hyperglycemia may not deliver the intended benefit or could even do more harm than good, answering this question is an important goal.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Historical control group (H) | – | Other: Sliding-Scale Insulin TherapyWinthrop patients with diabetes hospitalized between August 1, 2010 and March 31, 2011 |
| Intervention group (I) | – | Other: Physiologic Insulin TherapyWinthrop patients with diabetes hospitalized between August 1, 2011 and March 31, 2012 |
| Parallel control group (P-sub-H) | – | Other: Sliding-Scale Insulin TherapyPatients with diabetes hospitalized between August 1, 2010 and March 31, 2011 at 7 control hospitals located in the New York City metropolitan region |
| Parallel control group (I-sub-H) | – | Other: Sliding-Scale Insulin TherapyPatients with diabetes hospitalized between August 1, 2011 and March 31, 2012 at 7 control hospitals located in the New York City metropolitan region |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with type 2 diabetes mellitus admitted to a medical or surgical service
Key inclusion criteria (1 listed)
- Type 2 diabetes
Key exclusion criteria (3 listed)
- Pregnant
- Admitted directly to an intensive care unit
- Length of stay <2 days
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 |
|---|---|---|
| Physiologic Insulin Therapy | Other | Intervention group (I) |
| Sliding-Scale Insulin Therapy | Other | Historical control group (H), Parallel control group (I-sub-H), Parallel control group (P-sub-H) |
Primary outcome
Transfer to intensive care unit (y/n)
Time frame: Upon hospital discharge (median length of stay, 5 days)
Assigned "y" if patient is transferred to an intensive care unit for any length of time; otherwise, assigned "n".
7 secondary outcomes
Day-weighted proportion of blood glucose values within target range (100-180 mg/dL)
Time frame: Upon hospital discharge (median length of stay, 5 days)
Proportion of inpatient days involving any hypoglycemia (blood glucose<70 mg/dL)
Time frame: Upon hospital discharge (median length of stay, 5 days)
Proportion of inpatient days involving severe hypoglycemia (blood glucose<40 mg/dL)
Time frame: Upon hospital discharge (median length of stay, 5 days)
Proportion of inpatient days involving any hyperglycemia (blood glucose>200 mg/dL)
Time frame: Upon hospital discharge (median length of stay, 5 days)
Proportion of inpatient days involving severe hyperglycemia (blood glucose>300 mg/dL)
Time frame: Upon hospital discharge (median length of stay, 5 days)
Development of any complication (y/n)
Time frame: Upon hospital discharge (median length of stay, 5 days)
In-hospital death (y/n)
Time frame: Upon hospital discharge (median length of stay, 5 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 4 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Donald A Brand, Ph.D. principal investigator
Winthrop University 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 Mellitus, Type 2 and Hyperglycemia, run by Winthrop University Hospital 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 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 4 Jun 2019. 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?
Transfer to intensive care unit (y/n) (time frame: Upon hospital discharge (median length of stay, 5 days)). 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 4 Jun 2019; AzTrials last refreshed its copy on 8 Nov 2026.