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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23DK080228-05 | 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 goal of this research is to evaluate the impact and feasibility of using web-based patient-provider communication and a remote glucose monitoring tool to improve post-hospitalization glycemic control and patient self-care. The investigators hypothesize that providing patients this web-based tool over a 4-week period after discharge to home will result in more effective glycemic control compared to usual care, and that patients with access to the "tool kit" will have a trend towards improved diabetes self-management and less diabetes-related distress.
Diabetes affects 12-25% of all hospitalized adult patients, and 30% of hospitalized diabetes patients have one or more readmissions within one year. While glycemic control is rarely the primary reason for admission, poor glycemic control has been associated with increased rates of hospitalization and worse clinical outcomes, including infections, poor wound healing, and death. Hospitalization has been proposed as a "teachable moment" for patients with diabetes, as they have intensive contact with a full range of expert clinicians, but the effects of changes implemented during hospitalization after discharge are poorly studied.
The objective of this study is to conduct a randomized controlled trial to test a novel approach to diabetes management in the transition from inpatient to outpatient care. We will assign 40 hospitalized adult patients with type 2 diabetes to usual care or access to a web-based patient-provider communication and remote glucose monitoring tool ("Diabetes Transitions Tool Kit"). Our aims are to evaluate feasibility of implementation of the tool as well as impact on post-discharge glycemic control, diabetes-related self-care and distress. We hypothesize that providing patients this web-based tool over a 4-week period after discharge to home will result in more effective glycemic control compared to usual care, and that patients with access to the "tool kit" will have a trend towards improved diabetes self-management and less diabetes-related distress. Feasibility and preliminary data from this pilot study will be the foundation for larger-scale interventions that may ultimately improve the delivery of diabetes care in the transition from hospital to home.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Usual care for diabetes in the 1 month after discharge. | |
| Diabetes Transitions Tool Kit | Experimental | Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Transitions Tool Kit | Other | Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control | Mean patient-day weighted glucose (from glucometer downloads) over the 30 days after discharge | 1 month from discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Distress | Measured by the Problem Areas in Diabetes (PAID) Questionnaire | 1 month from discharge |
| Diabetes Self-Management | 1 month from discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy J Wei, MD | Massachusetts General Hospital | Principal Investigator |
| Deborah J Wexler, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Usual care for diabetes in the 1 month after discharge. |
| FG001 | Diabetes Transitions Tool Kit | Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge. Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Usual care for diabetes in the 1 month after discharge. |
| BG001 | Diabetes Transitions Tool Kit | Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge. Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 | Glycemic Control | Mean patient-day weighted glucose (from glucometer downloads) over the 30 days after discharge | Posted | Mean | Standard Deviation | mg/dL | 1 month from discharge |
|
Monthly
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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 | Usual Care | Usual care for diabetes in the 1 month after discharge. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Wei, MD | MGH Diabetes Center | 617-724-7597 | ncwei@mgh.partners.org |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Unplanned Readmission or ED Visit | Unplanned readmission to any hospital within 30 days of discharge. Emergency department admission to any hospital within 30 days of discharge. | 1 month after discharge |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
|
| Average HbA1c | Mean | Standard Deviation | % |
|
| Average glycated albumin | Mean | Standard Deviation | % |
|
|
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| Secondary | Diabetes Distress | Measured by the Problem Areas in Diabetes (PAID) Questionnaire | Not Posted | 1 month from discharge |
| Secondary | Diabetes Self-Management | Not Posted | 1 month from discharge |
| Secondary | Unplanned Readmission or ED Visit | Unplanned readmission to any hospital within 30 days of discharge. Emergency department admission to any hospital within 30 days of discharge. | Not Posted | 1 month after discharge |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Diabetes Transitions Tool Kit | Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge. Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge. | 0 | 14 | 0 | 14 |
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