Adaptation, Implementation, and Validation of an Innovative eHealth System for the Self-management, Monitoring, and Specialized Remote Medical Care of Patients With Diabetes in the Municipalities of Palermo (Huila) and Suárez (Cauca).

The proposed study corresponds to the development of a controlled, randomized, open-label clinical experiment included within the research protocol and approved by the Ethics Committee of Universidad Antonio Nariño. The activities will be carried out by a team composed of clinical scientific personnel, with technical support from Engineering personnel. The study is intended to evaluate the implementation and use of an eHealth system for the follow-up and care of people with type 2 diabetes mellitus (T2DM), integrating glucose data acquisition, clinical follow-up, and remote medical communication.

Study design and population The study will use a controlled, randomized, open-label clinical design. The population will consist of patients over 18 years of age with a diagnosis of type 2 diabetes mellitus for at least one year who are receiving follow-up at chronic patient care centers. Potential participants will be identified in the municipalities of Palermo, Huila, and Suárez, Cauca, among patients receiving follow-up at diabetes care centers who have been active in the chronic disease program for a minimum of three months.

To participate in the study, patients must meet specific inclusion criteria. An Glycosylated Hemoglobin (HbA1c) value equal to or greater than 7% is required, measured using BIOHERMES HbA1c from ANNAR Health Technologies. Participants must also be receiving insulin treatment with at least one daily application or have an indication for insulin treatment according to the corresponding clinical practice guideline. In addition, they must have access to a mobile phone with data, a condition required for the use of the technological components planned for the intervention group.

Exclusion criteria are established for clinical conditions that may interfere with the development or interpretation of the study. During the previous three months, exclusion criteria include acute diabetes decompensation, a 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, and severe liver disease.

Participant identification, selection, and informed consent The enrollment process will begin with the identification of patients diagnosed with T2DM who reside in Palermo, Huila, and Suárez, Cauca. Compliance with the inclusion and exclusion criteria will be verified, and potential participants will be confirmed to be active in the chronic disease program for the established minimum period.

Once a potential participant has been identified, the responsible investigator will explain the study objectives using simple and understandable language and will answer any questions or concerns that may arise. When the patient expresses willingness to participate, completion and signing of the informed consent form will be requested before any study-related procedure is performed.

The informed consent form was prepared using simple, clear, and understandable language, with short sentences and paragraphs. The document clearly and concisely explains the research objectives and recruitment criteria so that participants can understand the reasons for their selection. It also summarizes the main aspects of the information provided verbally and establishes that participants may voluntarily withdraw from the study at any time.

Study periods and general procedure The study includes a selection period and a treatment period. Before undergoing any study-related procedure, potential participants must have signed the informed consent form. During the screening phase, baseline clinical data, initial HbA1c values, and the incidence of hypoglycemia will be obtained. The screening phase lasts 14 days, and the study visits are organized around days 0, 15, 105, and 195.

Once it has been confirmed that the patient meets the requirements for participation, randomization will be performed. Participants will be assigned in a 1:1 ratio to the intervention and control groups, with a target of 50 participants per group. Allocation will be performed automatically through a server-based randomization system specifically designed for the study. The system will use permuted blocks of variable sizes of 4 and 6 and a cryptographically secure randomization mechanism. Each allocation will be processed through an individual Firestore transaction, preventing collisions when assignments are made simultaneously. The allocation sequence will remain concealed and will not be sent to the browser in order to preserve allocation concealment. In addition, the system will ensure that the same patient identifier always retains the same allocation and will record, for each participant, the user who performed the allocation, the date, the enrollment number, and the corresponding block, allowing process traceability and auditing. Allocation will be fully automatic and cannot be manually selected or modified. The study includes four visit points: V1 on day 0, V2 on day 15, V3 on day 105, and V4 on day 195.

These points correspond to follow-up from the initial assessment, through the selection stage and treatment period, to the subsequent evaluations planned during follow-up.

Intervention group and eHealth system Participants assigned to the intervention group will be users of the eHealth system and will receive training on the operation of the platform according to the study protocol and user manual. The system is designed to facilitate the acquisition of information from the main glucose meters used in Colombia, enable analysis through a web interface, and facilitate remote medical communication through a mobile application.

Data recorded or uploaded by patients to the platform will be reviewed every two weeks by a physician trained in diabetes management. This professional will be responsible for assessing the available information and making the corresponding therapeutic adjustments when hypoglycemia events or recurrent hyperglycemia episodes occur. Hypoglycemia events are considered values below 54 mg/dl and below 70 mg/dl, while recurrent hyperglycemia events are considered values above 180 mg/dl. Adjustments will be made according to previously established protocols and the 2024 ACE Clinical Practice Guideline for the treatment and follow-up of type 2 diabetes mellitus in the Colombian population over 18 years of age.

Recommendations regarding treatment adjustments will be provided through digital visits every two weeks, following protocols previously used in studies involving digital diabetes platforms. The system seeks to expand compatibility with most devices available for capillary blood glucose measurement in Colombia, reduce the complexity of its use, and enable its operation on private servers in an efficient and secure manner.

The system will be available as a mobile application through the Google Play Store, with the purpose of facilitating access for both patients and the clinical team during study implementation. A web version will also be available to facilitate information visualization and support participant self-management. Preliminary clinical results of the system have shown its potential for use in Colombia.

Control group Participants assigned to the control group will receive established usual care and capillary blood glucose self-monitoring. This group will have a regular visit every three months, during which capillary blood glucose data will be evaluated in person by the clinical team. Treating physicians may make the corresponding therapeutic adjustments according to established protocols and the 2024 ACE Clinical Practice Guideline for the treatment and follow-up of type 2 diabetes mellitus in the Colombian population over 18 years of age.

Both groups will undergo scheduled clinical assessments. At the baseline visit, corresponding to the 0-to-15-day interval, at the second visit, corresponding to the 90-to-105-day interval, and at the third visit, corresponding to the 180-to-195-day interval, blood pressure, weight, and HbA1c will be measured using BIOHERMES HbA1c from ANNAR Health Technologies. Information will also be collected regarding all medications used, hypoglycemia events reported by the patient or a family member, home glucose measurements, periods without medication, hospitalizations, and symptoms associated with possible adverse effects.

Clinical assessment, treatment satisfaction, quality of life, hypoglycemia, and usability During in-person visits, participants will complete patient-reported questionnaires in their Spanish-language versions at three time points of the treatment period, with weeks counted from randomization: baseline (week 0; V2, day 15), 3 months (week 12; V3, day 105), and 6 months (week 24; V4, day 195). The Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs), the Audit of Diabetes-Dependent Quality of Life (ADDQoL19), and the Hypoglycaemia Self-Report Questionnaire (HypoSRQ) will be administered to both groups at all three time points. At 6 months, the Diabetes Treatment Satisfaction Questionnaire, change version (DTSQc), will also be administered to both groups, and an adapted version of the Telehealth Usability Questionnaire (TUQ) will be administered to the intervention group.

The DTSQs measures satisfaction with the current diabetes treatment. It consists of eight items rated on a scale from 0 to 6. Six of these items make up the treatment satisfaction score, which ranges from 0 to 36, with higher scores indicating greater satisfaction. The remaining two items assess the perceived frequency of hyperglycemia and hypoglycemia.

The DTSQc will be administered only at 6 months (V4), with a recall period of the past 6 months. It contains the same eight items as the DTSQs, rated from -3 to +3, and asks participants to rate how their satisfaction with their treatment has changed over the past 6 months, that is, since the start of the treatment period. The treatment satisfaction change score ranges from -18 to +18. This version complements the DTSQs because it can detect improvements in participants whose satisfaction is already high at baseline, where the status version is limited by a ceiling effect.

The ADDQoL19 assesses the impact of diabetes on quality of life. It includes two overview items, one on present quality of life and one on diabetes-dependent quality of life, and 19 life domains. Examples include working life, family life, friendships and social life, leisure activities, physical health, freedom to eat and drink, financial situation, and feelings about the future. For each applicable domain, participants rate the impact of diabetes and the importance of that domain in their lives. The weighted impact scores are averaged into an average weighted impact (AWI) score ranging from-9, the maximum negative impact, to +3, the maximum positive impact.

The HypoSRQ records the frequency and severity of hypoglycemia episodes, including episodes managed by the participant and severe episodes that require assistance from another person, as well as the symptoms experienced and the impact of these episodes on daily life. This information will complement the hypoglycemia events identified through glucose records and clinical follow-up.

The usability of the eHealth system will be assessed at 6 months (V4) in the intervention group with an adapted version of the Telehealth Usability Questionnaire (TUQ; Parmanto et al., 2016). The adaptation uses plain Spanish language suited to the rural population of the study. It retains the 21 items and the six content dimensions of the original instrument (usefulness; ease of use and learnability; interface quality; interaction quality; reliability; and satisfaction and future use), as well as its 7-point response scale, from 1 (strongly disagree) to 7 (strongly agree), with a not-applicable option. The questionnaire will be administered by interview by trained personnel, preferably different from those who trained the participant on the platform or participate in their clinical care. Overall and dimension scores will be calculated as the mean of the responses, with higher scores indicating greater perceived usability.

Physical activity and dietary monitoring The protocol includes monitoring of variables related to nutrition and physical activity in order to reduce the possible "halo" effect associated with behavioral changes that may occur when individuals know that they are being observed. These variables are considered relevant because of their relationship with behavior and metabolic control.

For physical activity monitoring, the mobile application will incorporate the variable corresponding to the number of steps taken by each participant per day. This will provide information regarding physical activity levels throughout the study.

Regarding diet, both the control and intervention groups will receive training from a nutrition service. Calorie counting will be performed at the beginning of the study, at three months, and at six months in order to monitor this variable throughout the observation period.

Data protection and processing Information obtained during the study will be transferred in anonymized form so that the data subjects cannot be identified. Data recipients must use the information exclusively to fulfill the objectives established for the research. The protocol establishes that the data will not be used or transferred for commercial purposes.

Sample size The sample size was calculated based on the study by Lim et al. The calculation seeks to detect a mean difference associated with a 0.5% reduction in HbA1c, considering 80% statistical power, an alpha error of 0.05, and a standard deviation of one.

The initial calculation established a sample of 42 patients per arm in each municipality. Considering a potential 10% loss to follow-up, the required sample was established as 50 patients per arm in each municipality. Therefore, the total planned sample size for the study is 200 patients, distributed between the intervention and control groups across the municipalities included in the study.

Overall, the study establishes a structured process comprising participant identification and selection, verification of eligibility criteria, informed consent, baseline assessment, 1:1 randomization, differentiated follow-up according to assignment to the intervention or control group, periodic clinical assessments, monitoring of metabolic and behavioral variables, administration of treatment satisfaction, diabetes-dependent quality-of-life, hypoglycemia self-report, and usability questionnaires, and anonymized processing of information. The intervention group incorporates the eHealth system as a tool for remote acquisition and monitoring of glucose information and periodic medical communication, while the control group maintains follow-up through usual care and in-person assessment of capillary blood glucose. The protocol establishes a total of 200 participants distributed between the two municipalities and the two study groups.