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Poor accrual
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The study will evaluate the safety and efficacy of computerized GlucoMe App in patients with uncontrolled diabetes treated with MDI.
GlucoMe is an interactive system, which provides glucose management tools to both the patient and health care team (HCT). The system includes a decision support system to be used by the HCT aiming to aid clinical decision making with mathematical models. The system does not intend to replace clinical judgement and all recommendations are to be approved by the HCT.
Forty (40) diabetic patients on multiple daily insulin injection (MDI) with abnormal HbA1c and identified as potential end users of the device will be recruited to the study and screened according to the study inclusion and exclusion criteria. Patient's daily blood glucose will be measured and the GlucoMe App will give its recommendations for change in insulin dose, as well as recommendations for pre and post-meal carbohydrate and exercise. Patient's daily blood glucose levels will be followed by the HCT biweekly for 12 weeks and patients will be instructed to change their insulin doses according to the decision of the treating physician. At the end of the study, the HCT's recommendations for treatment adjustment will be compared to those of the system for both safety and efficacy. Study subjects and the HCT will be asked to complete a questionnaire regarding the GlucoMe system usability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GlucoMe App | Experimental | Self monitoring of glucose blood measurements using the GlucoMe glucose monitoring glucose device and App |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlucoMe App | Device | Assessment of the the GlucoMe App |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemic and Hyperglycemic Events | Number and severity of hypoglycemic and severe hyperglycemic events | At 12 weeks of the study |
| Correlation between GlucoMe and HCT recommendations | Correlation between GlucoMe and HCT recommendations for changing insulin dose and the treating physician/HCT advice. | At 12 weeks of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Target HbA1C/glucose achievement | Percent of patients that achieve HbA1C/glucose targets | At 12 weeks of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabitic Unit of the Wolfson Medical Center | Holon | Israel |
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| ID | Term |
|---|---|
| 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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