Development and Exploration of the Effectiveness and Feasbility of a Digital Intervention for Type 2 Diabetes Mellitus
NCT ID: NCT05364476
Last Updated: 2023-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
122 participants
INTERVENTIONAL
2022-04-11
2023-04-28
Brief Summary
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Detailed Description
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Primary objective is to study the proportion of participants with decrease in Hba1c by 0.6% by providing digital based lifestyle modifications. Secondary objectives include to 1) estimate the change in Hba1c, body mass index (BMI) and improvement in lipid profile components at week 16 compared with baseline readings; 2) to evaluate of the use of the Ramadan Risk Score (IDF-DAR Risk Stratification Scoring Tool); 3) to evaluate the rate of fasting and diabetes complications (hyperglycaemia / hypoglycaemia) amongst Muslims with T2DM during Ramadan.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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16 weeks digital intervention with online and offline support
This study is a single-arm, non-randomized clinical trial, which will collect participant's baseline data, apply relevant assessment scales, collect data using a comprehensive digital intervention in 16 weeks to evaluate the improvement of relevant markers post intervention.
16 weeks digital intervention
Participants will be enrolled into a 16-week program which consist of an online and offline support from health coaches and dietitian. Participants will be given diet and exercise recommendations and lesson plans on a weekly basis by the health coaches, and supported by the dietitian.
Participants will be required to log in their blood sugar levels, weight and steps daily using connected device, including glucometer, smart band and body fat weighing scale provided into the daily report card. They will also be required to manually record their meals and exercise daily in the daily report card provided upon enrollment into study. Reviews of log will be done on a weekly/biweekly interval by the health coaches.
Interventions
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16 weeks digital intervention
Participants will be enrolled into a 16-week program which consist of an online and offline support from health coaches and dietitian. Participants will be given diet and exercise recommendations and lesson plans on a weekly basis by the health coaches, and supported by the dietitian.
Participants will be required to log in their blood sugar levels, weight and steps daily using connected device, including glucometer, smart band and body fat weighing scale provided into the daily report card. They will also be required to manually record their meals and exercise daily in the daily report card provided upon enrollment into study. Reviews of log will be done on a weekly/biweekly interval by the health coaches.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HbA1c 7% and above in the latest blood test valid up to 12months prior to recruitment;
* age range between 20-70 years old;
* BMI between 23-50kg/m2
Exclusion Criteria
* Participants on insulin therapy or non-insulin injectable medication
* History of diabetes crisis (hyper or hypoglycaemia) in the past 6 months
* Blood pressure ≥ 160/100 mmHg
* Recurrent history of acute pancreatitis
* Decompensated liver cirrhosis
* eGFR \<60ml/min/1.73m2
* History of acute myocardial infarction/acute coronary syndrome(within the past 1 year), arrhythmias, heart failure (NY Class II -IV)
* Proliferative diabetic retinopathy-Foot ulcer, gangrene
* Deep vein thrombosis of lower limbs(within the past 12 months)
* Intermittent claudication -History of cerebral haemorrhage or acute cerebral infarction (within the past 12 months)
* History of active cancer
* Post-transplant/perioperative participants(defined as planned for operation for the next 6 months)
* History of hypo or hyperthyroidism, including subclinical states
* Musculoskeletal injuries resulting in difficulty to perform physical activities
* Failure to provide consent
* Unable to perform activities of daily livings (ADLs)
* Unable to use WhatsApp and YouTube via mobile devices, e.g. phone or tablet.
20 Years
70 Years
ALL
No
Sponsors
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Raja Isteri Pengiran Anak Saleha Hospital
OTHER_GOV
EVYD Technology
INDUSTRY
Responsible Party
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Principal Investigators
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Alice Moi Ling Yong, MBBS
Role: PRINCIPAL_INVESTIGATOR
Raja Isteri Pengiran Anak Saleha Hospital (RIPAS) Hospital
Locations
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EVYD Technology Limited
Singapore, , Singapore
Countries
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References
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Chan HN, Lim HS, Chong PL, Yung CK, Abd Mulok M, Wei Y, Yong AML. Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD): Protocol for a Clinical Nonrandomized Pilot Trial in Brunei Darussalam. JMIR Res Protoc. 2022 Dec 7;11(12):e43208. doi: 10.2196/43208.
Related Links
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Related Info
Other Identifiers
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MHREC/MOH/2022/4(1)
Identifier Type: -
Identifier Source: org_study_id
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