Establishing a Diabetes Registry Using the JADE-DIAMOND Electronic Portal (CN001)

NCT01274364 | Completed DMC

• 1 other identifier: CRE-2010-112
• Study Type: interventional
• Target: 3,586
• Locations: 1 country
• Sites: 1

Brief Summary

Quality diabetes care requires a team approach and informed decisions of patients and care providers. Several lines of evidence suggests that a protocol-driven care model delivered by trained staff with focus on periodic assessments, reinforcement of patient compliance and attainment of multiple treatment targets reduces risk of cardio-renal complications and early death in type 2 diabetes. The investigators hypothesize that the use of state of the art information technology to record, manage and analyze the large amount of clinical information generated during various consultation visits will improve the effectiveness and efficiency in implementing these care protocols through decision support and regular feedback to both patients and care team.

Conditions

Diabetes

Keywords

Diabetes; Structured Care

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who attain 2 or more of the 'ABC' targets

  Percentage of patients who attain 2 or more of the following 3 targets: * HbA1c \<7% * BP \<130/80 mmHg * LDL cholesterol \<2.6 mmol/L

  12 months

Secondary Outcomes (6)

• New onset of all diabetes-related endpoints

  12 months

• Quality of Life

  12 months

• Frequency of hypoglycaemia (in the last 3 months)

  12 months

• Behavioral changes (in the last 3 months)

  12 months

• Number of hospitalizations, follow up visits by doctors and other care professionals

  12 months

Study Arms (2)

JADE

EXPERIMENTAL

Patients will receive comprehensive assessments at baseline and again after 12-months. In the interim between these two time points patients will receive protocol-driven diabetes care using a web-based disease management program (JADE), delivered by a trio-team comprising of a trained doctor, nurse and physician assistant.

Other: JADE

DIAMOND

ACTIVE COMPARATOR

Patients will receive comprehensive assessments at baseline and again after 12-months. In the interim between these two time points patients will be managed according to 'usual care' procedures.

Other: DIAMOND

Interventions

JADE OTHER

Patients will receive comprehensive assessments at baseline and again after 12-months. In the interim between these two time points patients will receive protocol-driven diabetes care using a web-based disease management program (JADE), delivered by a trio-team comprising of a trained doctor, nurse and physician assistant.

JADE

DIAMOND OTHER

Patients will receive comprehensive assessments at baseline and again after 12-months. In the interim between these two time points patients will be managed according to 'usual care' procedures.

DIAMOND

Eligibility Criteria

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

You may qualify if:

• Type 2 diabetic patients attending hospitals or affiliated clinics led by PIs of the JADE Program who are living in the area with an intention to have 'regular' follow-up
• Aged \>18 years
• Patients can have newly diagnosed or established disease, treated with lifestyle or blood glucose lowering drugs including oral agents with or without insulin
• For newly diagnosed type 2 diabetic patients, their plasma glucose levels should be: a) Fasting plasma glucose (PG) \>7.0 mmol/L on 2 or more occasions, and/or b) Random (or post-OGTT 2h) PG \>11.1 mmol/L on 2 or more occasions, and/or c) HbA1c \>6.5%

You may not qualify if:

• Type 1 diabetes defined as a history of ketosis at diagnosis \[acute symptoms with heavy ketonuria (\>3+) or ketoacidosis\] or continuous requirement of insulin within one year of diagnosis
• Patients with reduced life expectancy (e.g. less than 6-months) due to recent diagnosis of advanced cancers (e.g. within last 2 years) and other life threatening conditions
• Patients with a mental condition rendering them unable to understand the nature, scope, and possible consequences of the study
• Patients actively enrolled in another intervention study
• Patients who are unwilling to return for regular follow up

Sponsors & Collaborators

• Asia Diabetes Foundation: lead

Study Sites (1)

Asia Diabates Foundation

Shatin, Hong Kong

Location

Related Publications (1)

• Tutino GE, Yang WY, Li X, Li WH, Zhang YY, Guo XH, Luk AO, Yeung RO, Yin JM, Ozaki R, So WY, Ma RC, Ji LN, Kong AP, Weng JP, Ko GT, Jia WP, Chan JC; China JADE Study Group. A multicentre demonstration project to evaluate the effectiveness and acceptability of the web-based Joint Asia Diabetes Evaluation (JADE) programme with or without nurse support in Chinese patients with Type 2 diabetes. Diabet Med. 2017 Mar;34(3):440-450. doi: 10.1111/dme.13164. Epub 2016 Jul 11.

  PMID: 27278933 DERIVED

Related Links

• Works of the Asia Diabetes Foundation, including the DIAMOND program.

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Diamond

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbon; Elements; Inorganic Chemicals

Study Officials

• Juliana Chan, MD

  Asia Diabetes Foundation

  PRINCIPAL INVESTIGATOR

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: January 9, 2011
• First Posted: January 11, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 5, 2015

Record last verified: 2015-03

Locations

HK (1)