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Evaluation of Morbidities, Endpoints and Reaching Targets in Diabetic Patients Managed by a Diabetes Specialist Team

NCT01690208 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2015-08-10

No results posted yet for this study

Summary

This is a pilot translational study aiming to compare the effects of a multi-component care program with personalized drug regimen augmented by behavioural therapy with psychological support and peer influence, led by a diabetes specialist team on metabolic control, psychological health and behaviours in difficult-to-treat type 2 diabetic patients versus usual care.

The study hypothesis is to evaluate a novel individualized, multicomponent care program to optimize glycemic control in difficult-to-treat type 2 diabetic patients.

Conditions

Interventions

OTHER

EMERALD

Patients assigned to the EMERALD group will be followed up at a Diabetes Centre led by the nurses and supported by diabetologists, with a particular emphasis on individualizing HbA1c goals and selecting drugs based on clinical profiles to maximize benefits and minimize harm. These patients will also undergo an intensive 3 to 4 months empowerment program where patients within the same group, and therefore sharing similar profiles, will return to the centre monthly to undergo a 2-3 hour activity session led by diabetes nurses, peer supporters and paramedics. Between medical visits, the nurses or HCA will telephone the patients at least once to provide support, help problem-shoot and remind them of their follow-up schedule.

OTHER

Usual Care

Patients randomised to the usual care group will receive their routine care after the initial baseline comprehensive assessment \& explanation of the JADE reports. A repeat comprehensive assessment will then be conducted at year 3.

Sponsors & Collaborators

  • Asia Diabetes Foundation

    lead OTHER

Principal Investigators

  • Juliana Chan, MD · Asia Diabetes Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2017-07-31
Completion
2017-12-31

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01690208 on ClinicalTrials.gov