Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT03775057
Eligibility Criteria:
Inclusion Criteria:
* Have type 2 diabetes
* Greater than 18 years and up to 75 years of age
* Use of basal insulin once a day or candidate for basal insulin once a day based on% HbA1c according to international guidelines and doctor's criteria
* HbA1c \> 7% in patients aged 18 to 65 years
* HbA1c \> 7.5% in patients older than 65 years
* Patients who use basal insulin twice a day or premix with diagnosed hypoglycemia and who are candidates for switching from therapy to a basal insulin of one application per day
* Have a Smartphone
* Informed consent signature
Exclusion Criteria:
* Refuse to participate in the study.
* Age younger than 18 years old and over 75 years old.
* Diabetes type 1 or gestational (other than type 2 diabetes mellitus).
* Patients with the following chronic complications of diabetes: retinopathy and chronic kidney disease with a glomerular filtration rate \<30 ml / min.
* The MyDose Coach tool is not appropriate for the patient or the use of the application is contraindicated (in the opinion of the Researcher, for example, patients with terminal illness, patients with cognitive or neurological disorders that are detailed below, patients who live alone and they do not have support from the family, patients with carpal tunnel who are not recommended to use a mobile phone, patients with musculoskeletal injuries in their hands, etc.)
* Patients who use insulin during the meal (short-acting analogue, regular human insulin or insulin premix) for more than 10 days in the last 3 months before the screening visit.
* Patients with severe hypoglycemia in the last 90 days.
* Hospitalization in the last 30 days (whatever the reason for hospitalization) In the last 3 months prior to the screening period: history of myocardial infarction, unstable angina, acute coronary syndrome, revascularization procedure, cerebrovascular accident requiring hospitalization.
* Severe or uncontrolled congestive heart failure (functional classification III and IV of the New York Heart Association \[NYHA\]).
* Use of systemic glucocorticoids (excluding topical application or inhaled forms) for a week or more within 90 days prior to the time of the test.
* Unable to meet specific protocol requirements (for example, inability to perform blood glucose measurements, administer your own insulin dose, or consider it unlikely that you will administer the titration safely according to your physician's guidance).
* Patients with cognitive disorders, dementia or any neurological disorder that affects the patient's ability to participate in the study, including the inability to understand the requirements of the study or to provide complete information about the adverse symptoms.
* Pregnant or breast-feeding women or women who intend to become pregnant during the study period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03775057
Study Brief:
Protocol Section:
NCT03775057