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

NCT01690208 | Unknown DMC

• 1 other identifier: CRE-2012.136-T
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes; Obesity

Keywords

Diabetes; Structure Care

Outcome Measures

Primary Outcomes (1)

• Glycemic control as measured by HbA1c compared to baseline

  Outcome measures will be assessed in all 600 patients in the both groups at 1 year and 3 year.

  36 months

Secondary Outcomes (3)

• Control of BP compared to baseline.

  36 months

• Control of low density lipoprotein (LDL) cholesterol compared to baseline.

  36 months

• Control of BMI and other obesity indices compared to baseline

  36 months

Study Arms (2)

EMERALD

EXPERIMENTAL

Patients assigned to the EMERALD group will be invited to join the multi-component program which will last for 1 year. This program will be held on a 4-weekly basis for the first 3-4 months followed by a maintenance program involving 2-4 group activities every year. Between clinic visits, patients in this group will also receive telephone reminders from the staff and peer supporters to reinforce compliance and for social support.

Other: EMERALD

Usual Care

ACTIVE COMPARATOR

Irrespective of the assignment group, all patients will undergo a baseline comprehensive assessment using the JADE portal disease management system. All patients will also receive a 2-hour session on how to interpret their individualised JADE report and risk profiles, whilst the importance of achieving targets and optimizing self care will be reinforced. Patients assigned to the UC group will be followed up in their usual clinic according to the 'standard' practice.

Other: Usual Care

Interventions

EMERALD OTHER

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.

EMERALD

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obese type 2 diabetic patients: body mass index (BMI) \>27 kg/m2 and/or waist circumference (WC) \>80cm in women and \>90cm in men and HbA1c \>8% aged 18-70 years
• Young type 2 diabetic patients: age 35-55 years and HbA1c \>8%
• Diabetic patients with established cardiovascular-renal complications: HbA1c \>8% and known cardiovascular and renal complications with chronic kidney disease (CKD) stage 3-4 (i.e. estimated glomerular filtration rate \<60 to \>15 ml/min/ per 1.73m2) aged 18-70 years.

You may not qualify if:

• Type 1 diabetes
• Active malignant disease (Patients with malignant disease who have been disease-free for at least 5 years are eligible)
• Life expectancy less than 12 months
• Any medical illness or condition as judged by the investigators as ineligible to participate the study.

Sponsors & Collaborators

• Asia Diabetes Foundation: lead

Study Sites (1)

DMEC Centre, Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Obesity

Interventions

fluoro-emerald

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Juliana Chan, MD

  Asia Diabetes Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana Chan, MD

CONTACT

jchan@cuhk.edu.hk

Rebecca Wong

CONTACT

wongymr@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 21, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 10, 2015

Record last verified: 2015-08

Locations

HK (1)