Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality

NCT07846319 | Not Yet Recruiting

• 1 other identifier: 00260026.5.0000.5330
• Study Type: interventional
• Target: 45,000
• Locations: 1 country
• Sites: 2

Brief Summary

Primary objective: To evaluate the effectiveness of the ARISE strategy on the proportion of individuals with confirmed T2DM diagnosis, per protocol criteria based on the PCDT-DM2 (Clinical Protocol and Therapeutic Guidelines for T2DM), among adults eligible for screening registered at UBS (Primary Health Care Units) in Afogados da Ingazeira, during the 12 months post-implementation, compared to a reference value estimated from a historical 12-month period in the same municipality. Methodology: Pragmatic, quasi-experimental, single-arm effectiveness and implementation study with a historical comparator. In each period, the analytic population will be defined by eligibility on the respective index date. In the historical period, data will estimate the reference proportion of the primary outcome and historical values of applicable secondary outcomes. In the post-intervention period, individuals eligible on the index date will be followed for 12 months via care records. Individuals who become eligible after the post-intervention index date may receive care actions under the strategy and be included in operational, implementation, and exploratory analyses, but not in outcome denominators fixed at the index date. The study will take place in Afogados da Ingazeira, Pernambuco, covering all 15 UBS with an affiliated Family Health Team. Research-specific technological components will incur no additional cost to the municipality. ARISE comprises two components:

1. 1.Digital analytics layer, built on the existing epHealth infrastructure. It uses structured data from e-SUS PEC to apply predefined T2DM screening eligibility rules. Identified individuals appear in operational lists and may generate alerts for UBS managers and community health workers, supporting visits, scheduling, test requests, follow-up, and patient return. It may also flag: delays over 60 days between test request and completion, availability of lab results, and need for active case-finding. No test, diagnosis, prescription, referral, or treatment is automated; clinical decisions remain with APS professionals and managers.
2. 2.Professional training. UBS managers, community health workers, physicians, nurses, and nursing technicians will be trained on the PCDT-DM2 and ARISE workflows, before the digital layer's activation. Professionals are research participants only for evaluating educational impact, acceptability, and usability, provided they attend the relevant training and sign the Informed Consent Form (ICF). Training participation is independent of research participation; declining data use carries no functional or institutional penalty.

Conditions

Diabetes Mellitus (Type 2); Prediabetes

Keywords

Diabetes Mellitus, Type 2; Prediabetic State; Primary Health Care; Noncommunicable Chronic Diseases

Outcome Measures

Primary Outcomes (1)

• Proportion of individuals with confirmed diagnosis of type 2 diabetes mellitus (T2DM)

  12 months post-intervention (compared to a 12-month historical reference period)

Study Arms (1)

ARISE Strategy

EXPERIMENTAL

Other: ARISE Strategy

Interventions

ARISE Strategy OTHER

This is a pragmatic, quasi-experimental, single-arm effectiveness and implementation study using a historical comparator. The ARISE strategy will consist of two components: (1) Digital analytics layer. The layer will use structured data extracted from the e-SUS PEC (Primary Care Information System) to apply predefined eligibility rules for T2DM screening. Identified individuals will be made available in operational lists and may generate alerts for UBS managers and community health agents and technicians. The alerts will support the organization of visits, contacts, scheduling, test requests, follow-up of pending items, and patients' return to the unit. No test, consultation, diagnosis, prescription, referral, or treatment will be carried out automatically. Clinical decision-making will remain the responsibility of professionals and managers. (2) Professional training: UBS managers, community health agents, community health agent technicians, physicians, nurses, and nursing technicians

ARISE Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• POPULATION FOR CARE-RELATED DATA: The population will consist of adults registered with municipal Primary Health Care who meet the eligibility criteria for T2DM screening on the index date of each period. In general, the following will be considered potentially eligible: (i) individuals aged 35 years or older; (ii) individuals aged 18 to 34 years with overweight or obesity and at least one risk factor defined in the protocol; (iii) individuals aged 18 years or older presenting certain high-risk conditions. Factors and conditions assessed include cardiovascular disease, dyslipidemia, arterial hypertension, prior laboratory-confirmed prediabetes, prior gestational diabetes, current pregnancy, antipsychotic use, obstructive sleep apnea syndrome, HIV/AIDS, cystic fibrosis, and history of transplantation.
• HEALTHCARE PROFESSIONAL PARTICIPANTS: Professionals will be considered research participants exclusively for the components evaluating educational impact, acceptability, and usability of the strategy. Eligible professionals will be those aged 18 years or older, currently working in the municipality, directly involved in the implementation or operationalization of the strategy, who attend the training corresponding to their role and agree by signing the Informed Consent Form (ICF). Participation in institutional training will not be contingent on participation in the research. Refusal to authorize the use of questionnaire data will not result in any functional, hierarchical, or institutional penalty.

You may not qualify if:

• POPULATION FOR CARE-RELATED DATA: Individuals with prior evidence of diabetes or with recent screening will be excluded, according to the windows and rules defined in the protocol. Criteria were limited to information that could be reliably identified in the structured fields of available data sources. The absence of a record of a given condition will not be interpreted as confirmation of its absence.
• HEALTHCARE PROFESSIONAL PARTICIPANTS: Professionals absent from training sessions due to vacation, leave, medical leave, or any other reason will not be included in the research components related to healthcare professionals.

Sponsors & Collaborators

• epHealth: lead
• Brazilian Diabetes Society: collaborator
• MERCK S/A: collaborator
• Municipal Health Secretariat of Afogados da Ingazeira: collaborator
• MOVE Academic Research Organization - Hospital Moinhos de Vento: collaborator
• epHealth Instituto: collaborator

Study Sites (2)

Municipal Health Secretariat of Afogados da Ingazeira

Afogados da Ingazeira, Pernambuco, 56800-000, Brazil

Location

epHealth

Florianópolis, Santa Catarina, 88032-005, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Leonardo A Carbonera, Dr.

CONTACT

48 936182615; leonardo@ephealth.com.br

Gabriela M Silva

CONTACT

48 936182615; gabriela@ephealth.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a pragmatic, quasi-experimental, single-arm effectiveness and implementation study using a historical comparator. The ARISE strategy will consist of two components: (1) Digital analytics layer. The layer will use structured data extracted from the e-SUS PEC (Primary Care Information System) to apply predefined eligibility rules for T2DM screening. Identified individuals will be made available in operational lists and may generate alerts for UBS managers and community health agents and technicians. The alerts will support the organization of visits, contacts, scheduling, test requests, follow-up of pending items, and patients' return to the unit. No test, consultation, diagnosis, prescription, referral, or treatment will be carried out automatically. Clinical decision-making will remain the responsibility of professionals and managers. (2) Professional training: UBS managers, community health agents, community health agent technicians, physicians, nurses, and nursing technicians

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)