Status:
COMPLETED
Efficacy of the Digital Platform for Diabetes Care Compared to Usual Care in Patients Diagnosed With Type 2 Diabetes.
Lead Sponsor:
Hospital Universitario San Ignacio
Conditions:
Type 2 Diabetes Treated With Insulin
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Introduction: In patients diagnosed with DM2, it is essential to achieve good metabolic control. One of the tools to optimize said control is self-monitoring with capillary glucometry or SMBG (Self Mo...
Eligibility Criteria
Inclusion
- Poor metabolic control with HbA1C ≥ 8% and ≤ 11% measured using a method certified by the National Glycohemoglobin Standardization Program (NGSP), ≤ 3 months before the screening visit.
- Patients who use insulin therapy in the basal plus scheme, basal-bolus, or with two or more applications of insulin per day.
- Not having modified therapy in the last 3 months
- Availability of access to a computer to download data.
- Mobile access with data.
- The subject's compliance with capillary glucose self-monitoring parameters was greater than 80% during the baseline period after the Screening Visit.
- Accept the study including signing the informed consent
Exclusion
- Acute decompensation of diabetes in the last 3 months
- History of myocardial infarction or acute coronary syndrome in the last three months before recruitment.
- Treatment with glucocorticoids in the last 3 months before the screening visit or who is scheduled to receive treatment during the study period
- Visual impairment that limits the ability to view or use the mobile application
- Cognitive impairment that, in the opinion of the principal investigator or study physician, would result in non-cooperation with study procedures.
- Active neoplastic disease or in the last year and/or life expectancy less than 6 months.
- Participating in another clinical study.
- Proliferative retinopathy, amputations attributable to diabetes, and/or severe peripheral neuropathy that could interfere with the ability to participate and follow the study.
- Pregnant or lactating, or plan to become pregnant during the study period
- Real-time or intermittent continuous glucose monitoring user.
- Significant psychiatric illness, kidney disease, severe liver disease, or other illness that affects the ability to complete the study.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2021
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05372471
Start Date
October 1 2020
End Date
August 31 2021
Last Update
May 12 2022
Active Locations (1)
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1
Hospital San Ignacio Hospital San Ignacio
Bogota, Cundinamarca, Colombia, 860.015.536-1