The study corresponds to a controlled, randomized, open-label clinical experiment approved by the Ethics Committee of Universidad Antonio Nariño, with the participation of clinical scientific personnel and technical support from Engineering. The study will include patients over 18 years of age with type 2 diabetes mellitus (T2DM) for at least one year, under follow-up at chronic patient care centers in Palermo, Huila, and Suárez, Cauca. Participants must have Glycosylated Hemoglobin (HbA1c) greater than 7%, i.e. HbA1c ≥7%, measured using BIOHERMES HbA1c, and receive insulin treatment with at least one daily application or have an indication for insulin treatment. In addition, they must have access to a mobile phone with data. Patients with, among other conditions, acute diabetes decompensation, recent history of myocardial infarction or acute coronary syndrome, glucocorticoid use, visual impairment or cognitive deterioration, proliferative retinopathy, amputations or severe peripheral neuropathy, pregnancy or breastfeeding, psychiatric disease, stage 4 or 5 kidney disease, or severe liver disease will be excluded.
Potential patients will be identified among those who have been active for at least three months in chronic disease programs. After verifying the eligibility criteria, the study objectives will be explained and informed consent will be requested, including the right to voluntary withdrawal at any time. The study comprises a 14-day selection period and a 180-day treatment period. During selection, baseline clinical data, HbA1c, and incidence of hypoglycemia will be obtained. Subsequently, Participants will be assigned in a 1:1 ratio to the intervention and control groups using a computer-generated random sequence managed centrally by the study server, ensuring allocation concealment with no possibility of modification by the treating physicians. The study will consist of four visits V1, V2, V3 and V4, corresponding to days 0, 15, 105, and 195, respectively.
The intervention group will use the eHealth system and will receive training according to the study protocol and user manual. Data recorded on the platform will be evaluated every two weeks by a physician trained in diabetes care, who may make therapeutic adjustments in the event of hypoglycemia or recurrent hyperglycemia, according to established protocols and the ACE 2024 clinical guideline. The system enables the acquisition of data from glucose meters, analysis through a web interface, and remote medical communication through a mobile application. The control group will receive usual care and capillary glucose self-monitoring, with in-person evaluations every three months and therapeutic adjustments according to established protocols.
During the visits, blood pressure, weight, HbA1c, medications used, hypoglycemia episodes, home glucose measurements, periods without medication, hospitalizations, and symptoms associated with adverse events will be evaluated. The DTSQs (treatment satisfaction), ADDQoL19 (diabetes-dependent quality of life), and HypoSRQ (self-reported hypoglycemia) questionnaires will also be administered at baseline (V2), 3 months (V3), and 6 months (V4). At 6 months, the DTSQc (change in treatment satisfaction) will be added for both groups, and an adapted version of the Telehealth Usability Questionnaire (TUQ) will be administered to the intervention group.
To control possible changes associated with the observation effect, physical activity will be monitored through daily step records and diet through nutritional training and calorie counting at baseline, three months, and six months. Data will be transferred in anonymized form and used exclusively for the research objectives, without commercial purposes.
The sample size was calculated to detect a 0.5% reduction in HbA1c, with 80% statistical power, an alpha error of 0.05, and a standard deviation of one. A total of 42 patients per arm in each municipality was estimated and, considering a 10% loss to follow-up, a sample of 50 patients per arm in each municipality was established, for a total of 200 patients.