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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK080228 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The hypothesis of this study is that using hospital admission to identify patients with poorly controlled diabetes (hemoglobin A1c levels >8%), and intervening during the hospitalization with targeted inpatient diabetes management will improve glycemic control at 3 and 12 months, with inpatient glycemic control, quality of life, and diabetes self-efficacy serving as secondary endpoints.
The study is a randomized, controlled trial of targeted inpatient diabetes management versus usual care in 70 general medical and surgical inpatients over age 18 with type 2 diabetes and hemoglobin A1c levels greater than 8% who are followed in Partners-affiliated primary care practices. In addition, we will enroll a prospective chart review cohort matched for age, sex, and HbA1c level whose course we will follow for one year after discharge to determine the patter of glycemia among patients who are not enrolled in a clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes Management Team | Experimental | Evaluation and management by diabetes management team |
|
| Control | No Intervention | Patients receive usual care for diabetes |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes management team | Other | MD evaluation followed by NP education and and medication titration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | Change in glycemic control measured by HbA1c change baseline to 6 months | 6 months from discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Average Intervention Effect Over 12 Months After Hospital Discharge | 12 months from discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah J Wexler, MD, MSc | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23036785 | Result | Wexler 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. |
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April, 2009 to May 2010, recruited from inpatient medical and surgical general care (non-ICU) inpatient units
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| ID | Title | Description |
|---|---|---|
| FG000 | Diabetes Management Team | Evaluation and management by diabetes management team including physician and nurse practitioner CDE. Physician performed diabetes medication initiation and/or titration and nurse performed CDE focusing on Diabetes Survival Skills. |
| FG001 | Control | Patients receive usual care for diabetes |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diabetes Management Team | Evaluation and management by diabetes management team |
| BG001 | Control | Patients receive usual care for diabetes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hemoglobin A1c | Change in glycemic control measured by HbA1c change baseline to 6 months | Posted | Mean | Standard Deviation | HbA1c, % | 6 months from discharge |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diabetes Management Team | Evaluation and management by diabetes management team |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah J. Wexler MD | Massachusetts General Hospital Diabetes Center | 617-726-8722 | dwexler@partners.org |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
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| Participants |
|
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| Secondary | Average Intervention Effect Over 12 Months After Hospital Discharge | Posted | Mean | Standard Error | HbA1c, % | 12 months from discharge |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Control | Patients receive usual care for diabetes | 2 | 16 | 0 | 16 |
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| D004700 | Endocrine System Diseases |