Diabetes Mellitus, Type 2 Clinical Trial
Official title:
An Evaluation of the Effect of a Diabetes Care Programme for People With Type 2 Diabetes Mellitus in Primary Care Setting: A Randomized Controlled Trial
Uncontrolled metabolic parameters and co-morbidity risk factors cause Diabetes Mellitus as
the leading cause of a multitude of micro-/macro-vascular complications. According to the
International Guidelines and Recommendations, people with Type 2 Diabetes Mellitus (T2DM)
should attend diabetes educational programmes periodically and optimize the metabolic index
of control. In Hong Kong, General Practitioners with solo-practice (GP-SP) have the least
availability of resources and support in DM management. A discrepancy of diabetes care
between public and private settings and a gap of clinical practice between public-private
healthcare settings is identified. In relation to the big population of T2DM is caring by
GP-SP but no structured Diabetes Care Programme (DCP) is in place. A structured DCP for T2DM
is in need to fill up the clinical gap and make beneficial to the target subjects.
The aim of this study is to evaluate the effectiveness of a DCP for people with T2DM in
primary care settings. It is a multi-center, single-blind randomized controlled trial with
parallel groups pre-test and post-test design. The evidence-based intervention (DCP) will be
carried out in a private primary care setting. People with T2DM attending the GP-SP who meet
the study criteria will be randomly assigned into one of the two study groups, either "DCP in
addition to usual medical care" or "Usual medical care only" as a control group. The
intervention group can beneficial in clinical and psychosocial outcomes after the completion
of the 20-week structured DCP with a greater improvement of HbA1c level, Self-Efficacy in
diabetes management, Diabetes Empowerment level, Diabetes Knowledge, and Quality of Life than
those who only received usual medical care at the GP-SP.
This study is to implement an evidence-based develop Diabetes Care Programme (DCP) for 152
adults with Type 2 Diabetes Mellitus (T2DM) in a few clinics of a general practitioner with
solo-practice (GP-SP) in community, and evaluate its effectiveness by comparing the outcomes
between study group (DCP with the usual medical care) and control group (Usual medical care
only). It is believed that a structured DCP can promote greater clinical outcomes improvement
and behavioral changes in the study group as evidence showed in literature. The primary
outcomes are glycemic control (HbA1c level) and Self-Efficacy in diabetes management; whereas
Diabetes Empowerment level, Diabetes Knowledge and Quality of Life are the secondary
outcomes.
The DCP consists of two parts, conduct 3 interactive group education with an innovative
educational tool "Diabetes Conversation Map™" sessions by dietitian and diabetes
educator/nurse. Then it followed by another 8 weeks for delivering two 15-30 minutes
teleconsultations for patient empowerment and follow-up of "Action Plan" by a diabetes
educator/nurse. Evaluation of outcomes will be done before the DCP (baseline), at week-8
(right after the group sessions), and at week-20 (4 weeks after the last teleconsultation).
In addition, a focus group interview will be carried out after the completion of the whole
intervention. It purposes to explore and get valuable descriptive information and feelings
from participants about the intervention and diabetes self-management.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
|
||
Completed |
NCT05647083 -
The Effect of Massage on Diabetic Parameters
|
N/A | |
Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
Completed |
NCT02836704 -
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
|
Phase 4 | |
Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
Completed |
NCT04562714 -
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
|
N/A | |
Completed |
NCT02009488 -
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
Completed |
NCT05896319 -
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
|
N/A | |
Recruiting |
NCT05598203 -
Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes
|
N/A | |
Completed |
NCT05046873 -
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
|
Phase 1 | |
Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
Terminated |
NCT04090242 -
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
|
N/A | |
Completed |
NCT03604224 -
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
|
||
Completed |
NCT03620357 -
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
|
N/A | |
Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
Completed |
NCT03620890 -
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
|
Phase 4 | |
Withdrawn |
NCT05473286 -
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
|
||
Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
Completed |
NCT04531631 -
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
|
Phase 2 |