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Teleconsultation study in diabetic patients

Pragmatic, unicentric, open-label, phase 2, non-inferiority, randomized controlled trial to evaluate the efficacy and safety of teleconsultation compared to face-to-face consultation of patients with Diabetes Mellitus referred from primary care to specialized care in the single health system

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-8gpgyd
Enrollment
Unknown
Registered
2019-12-27
Start date
2019-12-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus

Interventions

The intervention consists of a teleconsultation with an endocrinologist, performed by videoconference
the endocrinologist will be allocated to a specific room at the Boa Vista polyclinic, which will be prepared with equipment consisting of a computer with camera and audio, as well as a modem that will
Device

Sponsors

Hospital Alemão Oswaldo Cruz
Lead Sponsor
Ministério da Saúde
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients, both sexes, older than 18 years; diabetic patients, regardless of priority, according to the protocol defined in the study; patients diagnosed with type 2 diabetes mellitus, with any level of glycemic control measured by glycated hemoglobin and/or fasting glucose, who meet criteria for referral from primary care to specialized care; patients on insulin with glycated hemoglobin greater than 8

Exclusion criteria

Exclusion criteria: Patients under 18 years of age and Type 1 diabetes mellitus; patients with gestational diabetes mellitus or diagnosed during pregnancy; Patients with estimated or measured creatinine clearance below 30 ml / min / m2

Design outcomes

Secondary

MeasureTime frame
To evaluate changes in fasting blood glucose levels in patients with type 2 diabetes mellitus ;To evaluate changes in urea and creatinine levels in patients with type 2 diabetes mellitus ;To evaluate the levels of cholesterol, triglycerides, HDL cholesterol and serum LDL cholesterol in patients with type 2 diabetes mellitus ;To evaluate changes in systolic and diastolic pressure measurements, measured in UBS / office ;To assess changes in body weight and BMI measures ;To evaluate the incidence of hypoglycemia events ;Assess the incidence of adverse events ;To evaluate the use of teleconsultation as a service strategy for the control of type 2 DM ;To evaluate the satisfaction of health professionals working in the UBSs participating in the study, through a structured questionnaire. ;To evaluate the patients' satisfaction with the consultations by videoconference, through a structured questionnaire ;To evaluate the quality of life of the patients by the EQ-5D quality of life questionnaire specific to DM patients;To estimate the real cost of the teleconsultation service, through the TDABC (Time-driven Activity-based Costing) micro-accounting method way to obtain the unit cost of the teleconsultation and to analyze the productive capacity of the UBS in a real-world scenario

Primary

MeasureTime frame
The alternative non-inferiority hypothesis will be accepted if the upper limit of the 95% confidence interval of the difference in HbA1c means of the teleconsultation group in relation to the presence group is higher than 0.8%, assuming that the two groups will have reductions in the value of HbA1c after the query in relation to its base value

Countries

Brazil

Contacts

Public ContactDaniela;Daniela Laranja Rodrigues;Rodrigues

Hospital Alemão Oswaldo Cruz;Hospital Alemão Oswaldo Cruz

dlrodrigues@haoc.com.br;dlrodrigues@haoc.com.br+55-011-35490500;(11) 35490086

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 17, 2026