Diabetes Mellitus, Type 2NCT03455985
Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin
A study testing Discharge Order Set (DOS) in people with Diabetes Mellitus, Type 2 and Patient Discharge, run by Ohio State University at 1 site in United States.
Trial summary
Diabetes is present in 25% of hospitalized patients; yet effective hospital discharge programs for patients with diabetes are understudied. In particular, patients who are initiating or intensifying insulin therapy have the most to benefit in terms of glycemic control. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Patient Discharge, Blood Glucose, Low
- What is being tested?
- Discharge Order Set (DOS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 11 Sep 2020
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of diabetes, type 2 ≥3 months duration
- HbA1c >8.5%
- Ages 25-75 years
- Phone or electronic media availability
- Receiving basal insulin >10 unit/day
Who cannot join
- Sensitive admissions: Prisoners
- Pregnancy
- Unable to consent or follow study directions in English
- Expected nursing facility stay longer than 2 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Diabetes is present in 25% of hospitalized patients; yet effective hospital discharge programs for patients with diabetes are understudied. In particular, patients who are initiating or intensifying insulin therapy have the most to benefit in terms of glycemic control. However, these patients are also particularly vulnerable to poor transitions of care for a variety of reasons, including the complexity of therapy, inadequate patient education, differences in patient and provider expectations, and insufficient resources. Disruption of insulin therapy following hospitalization is associated with higher HbA1c, shorter survival, and increased readmissions and medical costs. In a Society of Hospital Medicine Survey, only one fourth of hospitals were supported with written protocols to standardize medication, education, equipment, and follow-up instructions. However, discharge order sets have largely been limited to the inpatient setting and have not been utilized to guide insulin use at hospital discharge. This study will assess whether a nurse supported diabetes focused inpatient discharge order set (DOS) can improve post-discharge outcomes among hospitalized patients with poorly controlled insulin-requiring diabetes.
Read the detailed description
In this 24 week randomized controlled trial, hospitalized insulin-requiring patients with type 2 diabetes and poor glycemic control (HbA1c >8.5%) will receive standard of care insulin therapy including basal insulin glargine U300 (TOUJEO®) plus additional background therapy (non-insulin and prandial insulin therapies) with either a diabetes focused discharge order set (DOS) and follow-up communication to facilitate insulin titration and outpatient follow-up or enhanced standard care (ESC). 222 patients (type 2 diabetes) will be recruited. Hospitalized patients with type 2 diabetes (HbA1c >8.5%) who are receiving basal insulin at least 10 unit per day and are able to provide informed consent and complete study procedures will be approached. All patients will be discharged on glargine U300 with initial doses determined by the discharging team. Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Patients will have follow-up phone calls at week 2, 6, and in-person visits at week 12 and 24. Phone calls will assess adherence with instructions for self-titration in the DOS group but are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. The study and all study-related documents will be approved by the OSU IRB. All data analyses will be completed as intention to treat analyses. Longitudinal outcomes (e.g., HbA1c) will be analyzed using mixed models utilizing all available measurements from individuals randomized.
- Being tested
- Discharge Order Set (DOS), Enhanced Standard Care (ESC)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discharge Order Set (DOS)Other
In addition to the elements in ESC, for the DOS group the primary team will be contacted to complete the Diabetes Discharge order set, which will be pre-populated into the electronic discharge navigator. Follow-up phone calls in the DOS group will also assess and reinforce insulin dose self-titration.
Enhanced Standard Care (ESC)Other
Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider.
| Study group | Role | What they receive |
|---|---|---|
| Discharge Order Set (DOS) | Experimental | Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Phone calls will assess adherence with instructions for self-titration. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. Receives: Other: Discharge Order Set (DOS) |
| Enhanced Standard Care (ESC) | Other | Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. Receives: Other: Enhanced Standard Care (ESC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c From Baseline to 24 Weeks
We will test for a difference in 24 week change in HbA1c between the DOS and ESC groups using a linear mixed model for the longitudinal HbA1c measurements. A Wald test of the treatment-by-time interaction will be used to test our primary hypothesis that DOS affects 24 weeks change in Hb1Ac.
Measured: 24 weeks
Secondary outcomes (3)
Change in HbA1c From Baseline to 12 Weeks
We will test for a difference in 24 week change in HbA1c between the DOS and ESC groups using a linear mixed model for the longitudinal HbA1c measurements. A Wald test of the treatment-by-time interaction will be used to test our primary hypothesis that DOS affects 12 weeks change in Hb1Ac.
Measured: 12 weeks
Proportion Using Insulin Glargine U300 at 24 Weeks
proportion of patients who remain on insulin glargine U300 at 24 weeks The difference in proportions of patients who remain on insulin glargine U300 at 24 weeks between treatment groups will be computed and compared using test of proportions.
Measured: 24 weeks
Fasting Glucose
We will test for a difference in fasting glucose between the DOS and ESC groups using a linear mixed model.
reported measure differs from original plan due to lack of fasting glucose in hospitalized patients.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start1 May 2018
- Primary completion11 Sep 2020
- Study completion11 Sep 2020
Why it stopped: interruption of study enrollment and procedures due to COVID-19 health crisis
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.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Dungan, Ohio State University
- Investigators
- Kathleen Dungan, M.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455985
- Sponsor's protocol ID
- 2017H0354
- Status last verified
- Jul 2023
- First submitted
- 28 Feb 2018
- Last updated
- 22 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cook CB, Seifert KM, Hull BP, Hovan MJ, Charles JC, Miller-Cage V, Boyle ME, Harris JK, Magallanez JM, Littman SD. Inpatient to outpatient transfer of diabetes care: planing for an effective hospital discharge. Endocr Pract. 2009 Apr;15(3):263-9. doi: 10.4158/EP.15.3.263.
PubMed 19364697Dungan K, Lyons S, Manu K, Kulkarni M, Ebrahim K, Grantier C, Harris C, Black D, Schuster D. An individualized inpatient diabetes education and hospital transition program for poorly controlled hospitalized patients with diabetes. Endocr Pract. 2014 Dec;20(12):1265-73. doi: 10.4158/EP14061.OR.
PubMed 25100371Wexler DJ, Beauharnais CC, Regan S, Nathan DM, Cagliero E, Larkin ME. Impact of inpatient diabetes management, education, and improved discharge transition on glycemic control 12 months after discharge. Diabetes Res Clin Pract. 2012 Nov;98(2):249-56. doi: 10.1016/j.diabres.2012.09.016. Epub 2012 Oct 1.
PubMed 23036785Kimmel B, Sullivan MM, Rushakoff RJ. Survey on transition from inpatient to outpatient for patients on insulin: what really goes on at home? Endocr Pract. 2010 Sep-Oct;16(5):785-91. doi: 10.4158/EP10013.OR.
PubMed 20350914Wheeler K, Crawford R, McAdams D, Robinson R, Dunbar VG, Cook CB. Inpatient to outpatient transfer of diabetes care: perceptions of barriers to postdischarge followup in urban African American patients. Ethn Dis. 2007 Spring;17(2):238-43.
PubMed 17682352Dungan KM. The effect of diabetes on hospital readmissions. J Diabetes Sci Technol. 2012 Sep 1;6(5):1045-52. doi: 10.1177/193229681200600508.
PubMed 23063030Wu EQ, Zhou S, Yu A, Lu M, Sharma H, Gill J, Graf T. Outcomes associated with insulin therapy disruption after hospital discharge among patients with type 2 diabetes mellitus who had used insulin before and during hospitalization. Endocr Pract. 2012 Sep-Oct;18(5):651-9. doi: 10.4158/EP11314.OR.
PubMed 22440990Rodriguez A, Magee M, Ramos P, Seley JJ, Nolan A, Kulasa K, Caudell KA, Lamb A, MacIndoe J, Maynard G. Best Practices for Interdisciplinary Care Management by Hospital Glycemic Teams: Results of a Society of Hospital Medicine Survey Among 19 U.S. Hospitals. Diabetes Spectr. 2014 Aug;27(3):197-206. doi: 10.2337/diaspect.27.3.197.
PubMed 26246780Wright A, Feblowitz JC, Pang JE, Carpenter JD, Krall MA, Middleton B, Sittig DF. Use of order sets in inpatient computerized provider order entry systems: a comparative analysis of usage patterns at seven sites. Int J Med Inform. 2012 Nov;81(11):733-45. doi: 10.1016/j.ijmedinf.2012.04.003. Epub 2012 Jul 18.
PubMed 22819199Neinstein A, MacMaster HW, Sullivan MM, Rushakoff R. A detailed description of the implementation of inpatient insulin orders with a commercial electronic health record system. J Diabetes Sci Technol. 2014 Jul;8(4):641-51. doi: 10.1177/1932296814536290. Epub 2014 May 25.
PubMed 24876450Yu CH, Sun XH, Nisenbaum R, Halapy H. Insulin order sets improve glycemic control and processes of care. Am J Med. 2012 Sep;125(9):922-8.e4. doi: 10.1016/j.amjmed.2012.02.018. Epub 2012 Jul 14.
PubMed 22800878Noschese M, Donihi AC, Koerbel G, Karslioglu E, Dinardo M, Curll M, Korytkowski MT. Effect of a diabetes order set on glycaemic management and control in the hospital. Qual Saf Health Care. 2008 Dec;17(6):464-8. doi: 10.1136/qshc.2006.021790.
PubMed 19064664Schnipper JL, Liang CL, Ndumele CD, Pendergrass ML. Effects of a computerized order set on the inpatient management of hyperglycemia: a cluster-randomized controlled trial. Endocr Pract. 2010 Mar-Apr;16(2):209-18. doi: 10.4158/EP09262.OR.
PubMed 20061280Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008 Oct 9;359(15):1577-89. doi: 10.1056/NEJMoa0806470. Epub 2008 Sep 10.
PubMed 18784090Barr CC. Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive insulin therapy, by The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. N. Engl. J. Med 342:381-9, 2000. Surv Ophthalmol. 2001 Mar-Apr;45(5):459-60. doi: 10.1016/s0039-6257(01)00187-4. No abstract available.
PubMed 11274700
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin
- ClinicalTrials.gov ID
- NCT03455985
- Acronym / sponsor ID
- 2017H0354
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: interruption of study enrollment and procedures due to COVID-19 health crisis
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 11 Sep 2020 (actual)
- Study completion
- 11 Sep 2020 (actual)
- First posted
- 7 Mar 2018 (actual)
- Results
- Posted 22 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes is present in 25% of hospitalized patients; yet effective hospital discharge programs for patients with diabetes are understudied. In particular, patients who are initiating or intensifying insulin therapy have the most to benefit in terms of glycemic control. However, these patients are also particularly vulnerable to poor transitions of care for a variety of reasons, including the complexity of therapy, inadequate patient education, differences in patient and provider expectations, and insufficient resources. Disruption of insulin therapy following hospitalization is associated with higher HbA1c, shorter survival, and increased readmissions and medical costs. In a Society of Hospital Medicine Survey, only one fourth of hospitals were supported with written protocols to standardize medication, education, equipment, and follow-up instructions. However, discharge order sets have largely been limited to the inpatient setting and have not been utilized to guide insulin use at hospital discharge. This study will assess whether a nurse supported diabetes focused inpatient discharge order set (DOS) can improve post-discharge outcomes among hospitalized patients with poorly controlled insulin-requiring diabetes.
Detailed description
In this 24 week randomized controlled trial, hospitalized insulin-requiring patients with type 2 diabetes and poor glycemic control (HbA1c >8.5%) will receive standard of care insulin therapy including basal insulin glargine U300 (TOUJEO®) plus additional background therapy (non-insulin and prandial insulin therapies) with either a diabetes focused discharge order set (DOS) and follow-up communication to facilitate insulin titration and outpatient follow-up or enhanced standard care (ESC). 222 patients (type 2 diabetes) will be recruited. Hospitalized patients with type 2 diabetes (HbA1c >8.5%) who are receiving basal insulin at least 10 unit per day and are able to provide informed consent and complete study procedures will be approached. All patients will be discharged on glargine U300 with initial doses determined by the discharging team. Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Patients will have follow-up phone calls at week 2, 6, and in-person visits at week 12 and 24. Phone calls will assess adherence with instructions for self-titration in the DOS group but are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. The study and all study-related documents will be approved by the OSU IRB. All data analyses will be completed as intention to treat analyses. Longitudinal outcomes (e.g., HbA1c) will be analyzed using mixed models utilizing all available measurements from individuals randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Discharge Order Set (DOS) | Experimental | Other: Discharge Order Set (DOS)Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Phone calls will assess adherence with instructions for self-titration. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. |
| Enhanced Standard Care (ESC) | Other | Other: Enhanced Standard Care (ESC)Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of diabetes, type 2 ≥3 months duration
- HbA1c >8.5%
- Ages 25-75 years
- Phone or electronic media availability
- Receiving basal insulin >10 unit/day
Key exclusion criteria (4 listed)
- Sensitive admissions: Prisoners
- Pregnancy
- Unable to consent or follow study directions in English
- Expected nursing facility stay longer than 2 weeks
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 |
|---|---|---|
| Discharge Order Set (DOS)In addition to the elements in ESC, for the DOS group the primary team will be contacted to complete the Diabetes Discharge order set, which will be pre-populated into the electronic discharge navigator. Follow-up phone calls in the DOS group will also assess and reinforce insulin dose self-titration. | Other | Discharge Order Set (DOS) |
| Enhanced Standard Care (ESC)Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. | Other | Enhanced Standard Care (ESC) |
Primary outcome
Change in HbA1c From Baseline to 24 Weeks
Time frame: 24 weeks
We will test for a difference in 24 week change in HbA1c between the DOS and ESC groups using a linear mixed model for the longitudinal HbA1c measurements. A Wald test of the treatment-by-time interaction will be used to test our primary hypothesis that DOS affects 24 weeks change in Hb1Ac.
3 secondary outcomes
Change in HbA1c From Baseline to 12 Weeks
Time frame: 12 weeks
Proportion Using Insulin Glargine U300 at 24 Weeks
Time frame: 24 weeks
Fasting Glucose
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19364697Cook CB, Seifert KM, Hull BP, Hovan MJ, Charles JC, Miller-Cage V, Boyle ME, Harris JK, Magallanez JM, Littman SD. Inpatient to outpatient transfer of diabetes care: planing for an effective hospital discharge. Endocr Pract. 2009 Apr;15(3):263-9. doi: 10.4158/EP.15.3.263.
- Background: PubMed 25100371Dungan K, Lyons S, Manu K, Kulkarni M, Ebrahim K, Grantier C, Harris C, Black D, Schuster D. An individualized inpatient diabetes education and hospital transition program for poorly controlled hospitalized patients with diabetes. Endocr Pract. 2014 Dec;20(12):1265-73. doi: 10.4158/EP14061.OR.
- Background: PubMed 23036785Wexler DJ, Beauharnais CC, Regan S, Nathan DM, Cagliero E, Larkin ME. Impact of inpatient diabetes management, education, and improved discharge transition on glycemic control 12 months after discharge. Diabetes Res Clin Pract. 2012 Nov;98(2):249-56. doi: 10.1016/j.diabres.2012.09.016. Epub 2012 Oct 1.
- Background: PubMed 20350914Kimmel B, Sullivan MM, Rushakoff RJ. Survey on transition from inpatient to outpatient for patients on insulin: what really goes on at home? Endocr Pract. 2010 Sep-Oct;16(5):785-91. doi: 10.4158/EP10013.OR.
- Background: PubMed 17682352Wheeler K, Crawford R, McAdams D, Robinson R, Dunbar VG, Cook CB. Inpatient to outpatient transfer of diabetes care: perceptions of barriers to postdischarge followup in urban African American patients. Ethn Dis. 2007 Spring;17(2):238-43.
- Background: PubMed 23063030Dungan KM. The effect of diabetes on hospital readmissions. J Diabetes Sci Technol. 2012 Sep 1;6(5):1045-52. doi: 10.1177/193229681200600508.
- Background: PubMed 22440990Wu EQ, Zhou S, Yu A, Lu M, Sharma H, Gill J, Graf T. Outcomes associated with insulin therapy disruption after hospital discharge among patients with type 2 diabetes mellitus who had used insulin before and during hospitalization. Endocr Pract. 2012 Sep-Oct;18(5):651-9. doi: 10.4158/EP11314.OR.
- Background: PubMed 26246780Rodriguez A, Magee M, Ramos P, Seley JJ, Nolan A, Kulasa K, Caudell KA, Lamb A, MacIndoe J, Maynard G. Best Practices for Interdisciplinary Care Management by Hospital Glycemic Teams: Results of a Society of Hospital Medicine Survey Among 19 U.S. Hospitals. Diabetes Spectr. 2014 Aug;27(3):197-206. doi: 10.2337/diaspect.27.3.197.
- Background: PubMed 22819199Wright A, Feblowitz JC, Pang JE, Carpenter JD, Krall MA, Middleton B, Sittig DF. Use of order sets in inpatient computerized provider order entry systems: a comparative analysis of usage patterns at seven sites. Int J Med Inform. 2012 Nov;81(11):733-45. doi: 10.1016/j.ijmedinf.2012.04.003. Epub 2012 Jul 18.
- Background: PubMed 24876450Neinstein A, MacMaster HW, Sullivan MM, Rushakoff R. A detailed description of the implementation of inpatient insulin orders with a commercial electronic health record system. J Diabetes Sci Technol. 2014 Jul;8(4):641-51. doi: 10.1177/1932296814536290. Epub 2014 May 25.
- Background: PubMed 22800878Yu CH, Sun XH, Nisenbaum R, Halapy H. Insulin order sets improve glycemic control and processes of care. Am J Med. 2012 Sep;125(9):922-8.e4. doi: 10.1016/j.amjmed.2012.02.018. Epub 2012 Jul 14.
- Background: PubMed 19064664Noschese M, Donihi AC, Koerbel G, Karslioglu E, Dinardo M, Curll M, Korytkowski MT. Effect of a diabetes order set on glycaemic management and control in the hospital. Qual Saf Health Care. 2008 Dec;17(6):464-8. doi: 10.1136/qshc.2006.021790.
- Toujeo prescribing instructionsLink provided by the sponsor.
- 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.
Kathleen Dungan, M.D. principal investigator
Ohio State 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 Discharge Order Set (DOS) in people with Diabetes Mellitus, Type 2 and Patient Discharge, run by Ohio State University 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 22 Feb 2024. 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?
Yes. Results are posted in the registry (first posted 22 Feb 2024). 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?
Change in HbA1c From Baseline to 24 Weeks (time frame: 24 weeks). 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 NCT03455985, which also lists 56 linked publications.
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 Feb 2024.