Status:
UNKNOWN
Optimizing Care of Patients Via Telehealth In Monitoring and Augmenting Their Control of Diabetes Mellitus
Lead Sponsor:
SingHealth Polyclinics
Collaborating Sponsors:
MOH Office for Healthcare Transformation (MOHT), Singapore
Phillips Healthcare, Singapore
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
26-65 years
Phase:
NA
Brief Summary
OPTIMUM study aims to use the telehealth-enabled chronic disease management programme for individuals with chronic diseases to provide timely intervention to prevent disease deterioration, increase co...
Detailed Description
Over 400,000 Singaporeans are living with diabetes, with PM Lee Hsien Loong calling it a "health crisis" and the Ministry of Health declaring a "War on Diabetes" in 2016. One in three Singaporeans has...
Eligibility Criteria
Inclusion
- 1 . Singapore Citizen or Permanent Resident
- 2\. Age 26 - 65 years (latest age of entry for insurance coverage is 65 at next birthday)
- 3\. Type 2 Diabetes Mellitus (HbA1c ≤ 10% and ≥ 7.5% per latest reading) with and without the following complications:
- Mild non-proliferative diabetic retinopathy without any macular or retinal involvement;
- Chronic Kidney Diseases up to stage 3
- 4\. Patients registered with participating polyclinic
- 5\. Non-smoker, or ex-smoker who has completely quit smoking for at least 12 months
- 6\. Existing user of smartphone and is willing to download the relevant mobile application (iPhone or Android phones are acceptable)
- 7\. Expressed willingness to use the telehealth system and devices according to study protocol during the study period
Exclusion
- Poorly controlled glycemic control with HbA1c \> 10% (latest reading)
- Cognitively impaired based on diagnosis of dementia or mild cognitive impairment (MCI) in the electronic health records (EHR)
- Existing conditions listed below, as documented in the EHR:
- Any proliferative diabetic retinopathy (moderate to severe) and any macular or other retinal complications;
- Chronic kidney disease Stage 4 or 5;
- Coronary arterial diseases.
- Cerebrovascular diseases such as transient ischemic attach (TIA) or stroke;
- Peripheral vascular disease (result from diabetic foot screening);
- Known cognitive impairment, including MCI
- Not able to use smartphone despite coaching
- Any end-stage disease with life prognosis of \< 2 year
- Patients who are not willing or are not able to commit to the entire Optimum program
- Pregnant women
- Currently enrolled in another study / programme involving a novel therapeutic drug or device
Key Trial Info
Start Date :
January 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT04306770
Start Date
January 20 2020
End Date
July 1 2022
Last Update
March 13 2020
Active Locations (1)
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1
Sengkang Polyclinic
Singapore, Singapore, 545025