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Jiangsu Province Center for Disease control-Hospital-Community integration comprehensive management program to patients with type 2 diabetes

Efficacy of integrated intervention program to reduce glycemic level and improve health outcomes in patients with type 2 diabetes

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001741279
Enrollment
1000
Registered
2018-10-23
Start date
2018-10-30
Completion date
2018-11-30
Last updated
2018-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study aims to evaluate integrated self-care intervention program to reduce the blood glucose and HbA1c level, and improve health status of patients with type 2 diabetes. It is hypothesised the intervention will be effective to reduce the glycamic level and improve quality of life, and overall wellbeing.

Interventions

Ten diabetes intervention sessions including scheduled glucose monitoring, diabetes specific nutritional plan, and group diabetes education are designed for this study. The number of sessions that participants attend is determined based on the pilot study we completed in 2017-2018. It was evident the intervention was effective if participants can attend at least 8 sessions. If participants skipped sessions, the local physicians will catch up the participants by phone or sending session materials

Ten diabetes intervention sessions including scheduled glucose monitoring, diabetes specific nutritional plan, and group diabetes education are designed for this study. The number of sessions that participants attend is determined based on the pilot study we completed in 2017-2018. It was evident the intervention was effective if participants can attend at least 8 sessions. If participants skipped sessions, the local physicians will catch up the participants by phone or sending session materials to participants so they can catch up with the activity contents. These participants will be given opportunities to participate in activities to review their understanding of the intervention content. All intervention group participants will be provided diabetes intervention materials used for weekly group activities led by experienced community based physicians. The diabetes intervention materials are specially designed for this study. Each group consisted of 10-15 patients for 1 to 1.5 hours activities. The information included the following topics: thoughts and beliefs in diabetes management, diabetes self care behavious, behavioral and lifestyle modification including quitting smoking and drinking, physical activity, and knowledge of diabetes education, diabetes self care skills, healthy eating instruction and low glycemic foods based on Chinese Health Diet plan. In the education and information sessions, participants will attend workshop, learn the content through demonstrations, to conduct role plays and group discussion, Participants will attend weekly group sessions at their respective communities. For each session, it lasted 60 to 90 minutes, participants met with a community physician for diet consultations and medical evaluation in the same session. This includes review of behavioural modifications actions, assessment of blood glucose measurements and adjustment of medications. The integrative health care model will be developed by integrating Disease Control Center as project management, tertiary hospital to provide guidance and training and community doctors to do monitoring and management. We are also trialing the online monitoring the patients weight control by using E-health method. This measure participants body weight, BMI, fat, bone and muscle strength, and metabolism process. Participants will measure their weights every week six months. The APP developed for the intervention will receive patients data and provide patients guidance after they send data through telecommunication method.

Sponsors

Jing Sun
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

All participants will need to provide written informed consent before being enrolled into the study. Inclusion criteria include men and women 18-80 years of age, diagnosed with T2DM.

Exclusion criteria

Participants will be excluded from the study if they are pregnant, taking medications, had advanced diabetes complications, taking insulin, or had a recent history of a cardiovascular event, cancer, or other chronic disease that might interfere with participation.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026