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| Name | Class |
|---|---|
| Massachusetts Institute of Technology | OTHER |
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The purpose of this study is to determine if using a diabetes management technology system, including a tablet computer, to track diabetes care and communicate with a clinician coach (a doctor or nurse from the Joslin Clinic) makes starting and adjusting insulin easier and safer for people with type 2 diabetes. Hypothesis: The use of a diabetes management technology system with a clinician coach helps more individuals starting basal insulin achieve better glycemic control with less hypoglycemia compared with standard clinical practice at Joslin Diabetes Center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected. |
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| Control Group | No Intervention | The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tablet Computer | Device |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control as Determined by the Change in Absolute HbA1c Level | The primary outcome of interest is absolute decrease in A1c by end of 3 months. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reaching Target of HbA1c ≤ 7% | Secondary outcomes will include % of participants reaching glycemic target of A1c≤7. | 3 months |
| Change in Average Participation Satisfaction |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| William Hsu, M.D. | Joslin Diabetes Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected. Tablet Computer |
| FG001 | Control Group | The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected. Tablet Computer |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 as Determined by the Change in Absolute HbA1c Level | The primary outcome of interest is absolute decrease in A1c by end of 3 months. | Posted | Mean | Standard Deviation | Percent A1C | 3 months |
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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 | Intervention Group | The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected. Tablet Computer |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr William Hsu | Joslin Diabetes Center | 617-309-5803 | william.hsu@joslin.harvard.edu |
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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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The volunteer's satisfaction with their diabetes care will be measured at the beginning and at the end of the study. Diabetes Treatment Satisfaction Questionnaire (DTSQ) was used for assessing the satisfactory level. DTSQ consisted of 8 questions, each question with a score scale of 0-6 (very dissatisfied to very satisfied), leading to a final score range of 0-48, with higher scores indicating greater satisfaction. The change in the DTSQ comparing before (time 0) and end of the study (t=3months) was measured. The average change in the intervention group and control group were listed in the outcome measure data table.
| 3 months |
| Number of Participants With Hypoglycemia | Number of participants had hypoglycemia during the trial period | 3 months |
| Time Health Care Providers and Subjects Spend on Managing the Insulin Titration | time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes | 3 months |
| BG001 | Control Group | The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
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| Secondary | Number of Participants Reaching Target of HbA1c ≤ 7% | Secondary outcomes will include % of participants reaching glycemic target of A1c≤7. | Posted | Count of Participants | Participants | 3 months |
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|
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| Secondary | Change in Average Participation Satisfaction | The volunteer's satisfaction with their diabetes care will be measured at the beginning and at the end of the study. Diabetes Treatment Satisfaction Questionnaire (DTSQ) was used for assessing the satisfactory level. DTSQ consisted of 8 questions, each question with a score scale of 0-6 (very dissatisfied to very satisfied), leading to a final score range of 0-48, with higher scores indicating greater satisfaction. The change in the DTSQ comparing before (time 0) and end of the study (t=3months) was measured. The average change in the intervention group and control group were listed in the outcome measure data table. | Posted | Mean | Standard Deviation | Scores on a scale | 3 months |
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| Secondary | Number of Participants With Hypoglycemia | Number of participants had hypoglycemia during the trial period | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Time Health Care Providers and Subjects Spend on Managing the Insulin Titration | time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes | Posted | Mean | Standard Deviation | min | 3 months |
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| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Control Group | The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer. | 0 | 20 | 0 | 20 |
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