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Each subject enrolled in the study will be requested to complete an intake questionnaire including diabetes quality of life questions. The subject will use Dario Blood glucose monitoring system and will be contacted by a Certified Diabetes Educator (CDE) two to three times a month as well as have a direct communication using other communication channels such as mail, chat and text messaging (SMS) for lifestyle and diabetes management coaching for a total duration of three months. In the end of study, the subject will complete a diabetes quality of life questionnaire and have a blood test to evaluate its clinical parameters.
This study is designed to assess the effect of digital self-monitoring platform used with the remote support of a Health coach on clinical outcomes and Diabetes quality of life.
Study design will be an open-label randomized trial of adults with Type 2. Patients are recruited through the Diabetes and Endocrinology Consultants center setting. Upon randomization to the intervention group, study participants will receive three months diabetes health coaching comprising of:
The coach will get access to the patients' App captured information and will intervene ad necessary in the context of the clinical information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital platform and CDE coaching intervention for patients with type 2 Diabetes | Experimental | Patients provided with digital platform and connected devices. They undergo digital and human (CDE) intervention based on patient captured clinical data. Clinical parameters (HbA1C, weight, lipids profile, etc.) before and after intervention is assessed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dario Blood Glucose Monitoring System | Device | Dario Blood Glucose Monitoring System (BGMS) with Dario App and Dario digital platform |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1C Value at 3 Months From Subject Start of Study Compared to Baseline | Change of HbA1C taken in blood test 3 month from the subject start of the study. Data was compared to baseline and reporting the HbA1C change from baseline measurement and 3 months after subject start of the clinical study. Measurement was conducted by Quest labs. | During 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Cholesterol Value at 3 Months From Subject Start of Study | Change of Cholesterol taken in blood test 3 month from the subject start of the study Data was compared to baseline and reporting the Cholesterol change from baseline measurement and 3 months after subject start of the clinical study. Measurement was conducted by Quest labs, | During 3 months |
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Inclusion Criteria:
To be eligible to participate in this study, a subject must meet all the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Schorr, Dr. | Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC) | Feasterville | Pennsylvania | 19047-1845 | United States |
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No significant events occurred after study participant enrollment. 2 people were inactive.
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| ID | Title | Description |
|---|---|---|
| FG000 | Individual's Quality of Life and Clinical Parameters | Clinical parameters (HbA1C, weight, lipids profile, etc.) Dario Blood Glucose Monitoring System: Dario Blood Glucose Monitoring System (BGMS) with Dario App and Dario digital platform CDE: Certified Diabetes Educator Sessions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Individual's Quality of Life and Clinical Parameters | Clinical parameters (HbA1C, weight, lipids profile, etc.) Dario Blood Glucose Monitoring System: Dario Blood Glucose Monitoring System (BGMS) with Dario App and Dario digital platform CDE: Certified Diabetes Educator Sessions |
| 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 | HbA1C Value at 3 Months From Subject Start of Study Compared to Baseline | Change of HbA1C taken in blood test 3 month from the subject start of the study. Data was compared to baseline and reporting the HbA1C change from baseline measurement and 3 months after subject start of the clinical study. Measurement was conducted by Quest labs. | Posted | Mean | Standard Deviation | percentage of HBA1C in blood | During 3 Months |
|
9 months
Reporting requirements are provided in compliance with 21 CFR 812.150(b) (1).
All-Cause Mortality: No mortalities were recorded during the study Serious Adverse Events: No serious adverse events were recorded during the study Other (Not Including Serious) Adverse Events: No other adverse events were recorded during the study
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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 | Individual's Quality of Life and Clinical Parameters | Clinical parameters (HbA1C, weight, lipids profile, etc.) Dario Blood Glucose Monitoring System: Dario Blood Glucose Monitoring System (BGMS) with Dario App and Dario digital platform CDE: Certified Diabetes Educator Sessions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alan Schorr | Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC) | 2157501691 | abs@sugardoc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2018 | Jan 25, 2021 | Prot_SAP_000.pdf |
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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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| CDE | Behavioral | Certified Diabetes Educator Sessions |
|
| Weight Value at 3 Months From Subject Start of Study | Change of Weight taken in the clinic at the beginning of the study and 3 month from the subject start of the study Data was compared to baseline and reporting the weight change from baseline measurement and 3 months after subject start of the clinical study. | During 3 months |
| Triglycerides Value at 3 Months From Subject Start of Study | Change of Triglycerides taken in blood test 3 month from the subject start of the study Data was compared to baseline and reporting the Triglycerides change from baseline measurement and 3 months after subject start of the clinical study. Measurement was conducted by Quest labs, | During 3 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| HBA1C>8.5 | 2 participants were inactive during the study | Mean | Standard Deviation | percentage of HBA1C in blood |
|
| Weight | 2 participants were inactive during the study | Mean | Standard Deviation | lbs |
|
| Total Cholesterol | 2 participants were inactive during the study | Mean | Standard Deviation | mg/dL |
|
| Triglycerides value | 2 participants were inactive during the study | Mean | Standard Deviation | mg/dL |
|
| Units |
|---|
| Counts |
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| Participants |
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|
| Secondary | Cholesterol Value at 3 Months From Subject Start of Study | Change of Cholesterol taken in blood test 3 month from the subject start of the study Data was compared to baseline and reporting the Cholesterol change from baseline measurement and 3 months after subject start of the clinical study. Measurement was conducted by Quest labs, | Posted | Mean | Standard Deviation | mg/dL | During 3 months |
|
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| Secondary | Weight Value at 3 Months From Subject Start of Study | Change of Weight taken in the clinic at the beginning of the study and 3 month from the subject start of the study Data was compared to baseline and reporting the weight change from baseline measurement and 3 months after subject start of the clinical study. | Posted | Mean | Standard Deviation | lbs | During 3 months |
|
|
|
| Secondary | Triglycerides Value at 3 Months From Subject Start of Study | Change of Triglycerides taken in blood test 3 month from the subject start of the study Data was compared to baseline and reporting the Triglycerides change from baseline measurement and 3 months after subject start of the clinical study. Measurement was conducted by Quest labs, | Posted | Mean | Standard Deviation | mg/dL | During 3 months |
|
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D004700 | Endocrine System Diseases |