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| Name | Class |
|---|---|
| Hospital Clinica Nova | OTHER |
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Scientific studies show that the introduction of digital tools led to: Significant improvement in glycemic control, greater patient satisfaction, reduction of emotional burden, reduction of fear of hypoglycaemia, reduction of anxiety of the regimen, significantly fewer of additional visits to the doctor in addition to those scheduled and a reduction of resources.
Primary Objective:
To evaluate the efficacy and safety of the MyDose Coach digital tool in patients with T2D with basal insulin or candidates for the use of basal insulin.
Secondary Objectives:
Evaluate demographic variables and control variables (HbA1c, SMPG, FPG). Measure the units of insulin used before and after the intervention
The maximum study duration will be 29 weeks per patient that will consist of a 12-week screening period, a 16-week treatment period, and 1-week follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MyDose Coach app intervention | Experimental | The intervention involves the use of the MyDose Coach application, which has been previously programmed with the following titration scheme according to fasting glucose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyDoseCoach app | Other | The intervention involves the use of the MyDose Coach application, which has been previously programmed with the following titration scheme according to fasting glucose. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients reaching fasting SMPG target without a severe hypoglycemic episode during the 16-week on-treatment period | Percentage of patients reaching fasting SMPG (Self-Measured Plasma Glucose) target range 90-130 mg/dL (5.0-7.2 mmol/L) at Week 16 (mean of the last 4 readings recorded over the last 2 weeks) without a severe hypoglycemic episode (defined as having low blood glucose levels that requires assistance from another person to treat) during the 16-week on-treatment period | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean HbA1c change from baseline | Mean Glycated hemoglobin A1c (in percentage) from baseline | 16 weeks |
| Percentage of patients reaching HbA1c of <7.5% and <7% | Percentage of patients reaching Glycated hemoglobin A1c of <7.5% and <7% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hector Eloy Tamez, PhD | Contact | 5218183483220 | hectoreloytp@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Nova | Recruiting | San Nicolás de los Garza | Nuevo León | Mexico |
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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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| 16 weeks |
| Mean fasting SMPG glucose change from baseline | Mean fasting Self-Measured Plasma Glucose (mean of the last 4 readings recorded over the last 2 weeks, in mg/dl) | 16 weeks |
| Time to reach the first fasting SMPG target | Time in weeks to reach the first fasting SMPG target range of 90-130 mg/dL (5.0-7.2 mmol/L) | 16 weeks |
| Mean FPG glucose change from baseline | Mean fasting plasma glucose glucose change from baseline, in mg/dl | 16 weeks |
| Percentage of patients with hypoglycemic events | Percentage of patients with hypoglycemic events (blood glucose less than 70 mg/dL) | 16 weeks |
| Number of hypoglycemic events | Number of hypoglycemic events (blood glucose less than 70 mg/dL) | 16 weeks |
| Percentage of patients with adverse events | Percentage of patients with adverse events (other than hypoglycemia) | 16 week |
| Assessment of emotional well-being using WHO-5 well-being index | Assessment of emotional well-being using WHO-5 well-being index. The World Health Organisation- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing. | 16 week |
| D004700 | Endocrine System Diseases |