Effects of the General Practitioners and Diabetes Specialists Co-management Model for Patients With Type 2 Diabetes

NCT05556161 | Completed

• 1 other identifier: GPDSCM-T2DM
• Study Type: interventional
• Target: 609
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, parallel, multicenter controlled study to evaluate the effectiveness of the general practitioners and diabetes specialists co-management model for type 2 diabetes. Patients with type 2 diabetes will be randomized to participate in the community general practitioners and diabetes specialists management or serve as controls continuing with routine primary health care. The primary outcome is to observe the HbA1c change.

Conditions

Type2diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c change

  The change of HbA1c during the study. The level of HbA1c in blood measured in %.

  Baseline, 6, and 18 months

Secondary Outcomes (11)

• Fasting Plasma Glucose

  Baseline, 6, and 18 months

• Total cholesterol

  Baseline, 6, and 18 months

• Triglycerides

  Baseline, 6, and 18 months

• LDL-C

  Baseline, 6, and 18 months

• HDL-C

  Baseline, 6, and 18 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

The 12-month general practitioners and diabetes specialists co-management will be received by intervention group participants.

Behavioral: General Practitioners and Diabetes Specialists Co-management

Control group

NO INTERVENTION

Routine primary health care will be received by control group participants during the course of the Study.

Interventions

General Practitioners and Diabetes Specialists Co-management BEHAVIORAL

Self-monitoring of blood glucose: Participants will monitor blood glucose with a a free intelligent home blood glucose meter. Then, the intelligent blood glucose meter will upload data to the platform. Glycosylated hemoglobin check: Cooperative General Practitioner-Specialist Management: Based on the remote monitoring of blood glucose, general practitioners and specialists will jointly carry out management measures including health education, medication adjustment, outpatient consultation, referral, case discussion, etc. for participants.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with type 2 diabetes for over 1 year according to the diagnostic criteria of diabetes formulated by the World Health Organization;
• Male or female residents aged 18-85 years;
• HbA1c measured within 6 months before enrollment was 7.0%-10.0%;
• Lived in the catchment and have established health records for at least 6 months, and have no plans to move out at present;
• patients used smartphones;
• Sign the informed consent and participate in the study voluntarily.

You may not qualify if:

• Patients used insulin within 1year before enrollment;
• patients with type 1 diabetes, Latent autoimmune diabetes of adults(LADA), gestational diabetes, patients with extremely poor islet function (fasting C-peptide \< 0.1ng/ml) and patients with special type of diabetes;
• Patients used continuous glucose monitoring (CGM) in the past 3 months;
• Patients with serious complications (such as Stage G5 of diabetic nephropathy, severe loss of vision or blindness due to diabetic retinopathy and patients without self-care ability due to diabetic foot amputation).
• Patients who suffered from serious mental illness or late stage of other serious diseases (such as malignant tumors, acute cardiovascular disease (like stroke, myocardial infarction), serious liver insufficiency, patients with history of diabetic ketoacidosis, patients with alcohol or drug abuse or dependence and patients with a history of cardiac surgery in the last 3 months;
• Patients with cognitive impairment, or patients unable to use mobile phones to answer calls.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Baoan Central Hospital of Shenzhen: collaborator

Study Sites (1)

Baoan Central Hospital of Shenzhen

Shenzhen, Guangdong, 518102, China

Location

MeSH Terms

Interventions

General Practitioners

Intervention Hierarchy (Ancestors)

Physicians; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Xiaoxv Yin

  Huazhong University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant will be blinded of which treatment group subject is assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the office of social science and health management

Model Details: In parallel arm design, subjects are randomized to one or more study arms and each study arm will be allocated a different intervention. After randomization each subject stays in their assigned treatment arm for the duration of the study. Subjects receive the same treatment throughout the trial. The results are then compared.

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: October 1, 2021
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 30, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)