Status:
COMPLETED
Effectiveness of Education, Medication Adjustment and Telemonitoring in Reducing Diabetes Complications During Ramadan
Lead Sponsor:
Sengkang General Hospital
Collaborating Sponsors:
SingHealth Polyclinics
Singapore Clinical Research Institute
Conditions:
Diabetes Mellitus
Fasting
Eligibility:
All Genders
21-100 years
Phase:
NA
Brief Summary
Introduction Diabetes is a global emergency with detrimental clinical and financial consequences. Poorly managed diabetes leads to a myriad of serious complications, especially cardiovascular and infe...
Eligibility Criteria
Inclusion
- \-
- Participants must meet all of the inclusion criteria to participate in this study:
- Adults aged at least 21 years old,
- Able to fast at least 15 days in Ramadan based on experience of fasting in previous year's Ramadan,
- Known physician-diagnosed diabetes mellitus (DM) based on the following criteria before starting treatment
- a. Symptoms of polyuria, polydipsia and unexplained weight loss with i. fasting glucose ≥ 7.0mmol/l or ii. random plasma glucose ≥ 11.1 mmol/l or iii. 2-hour post 75g oral glucose challenge test plasma glucose ≥ 11.1 mmol/l b. Absence of symptoms of polyuria, polydipsia and unexplained weight loss with the following tests done twice showing the values i. fasting glucose ≥ 7.0mmol/l or ii. random plasma glucose ≥ 11.1 mmol/l or iii. 2-hour post 75g oral glucose challenge test plasma glucose ≥ 11.1 mmol/l
- Performed laboratory tests as per standard care : serum glycated hemoglobin A1c (HbA1c) level, blood Low Density Lipoprotein-Cholesterol, blood triglyceride level, blood High Density Lipoprotein-Cholesterol, blood Total Cholesterol and serum creatinine
- Most recent HbA1c level was \>7.0% (\>53mmol/mol)
- Ability to give informed consent,
- Ability to perform weekly recordings in the diary,
- Able to use and owns a mobile phone for recordings on mobile application
- Should have had DM-related clinic visits or hospitalization in the past 10 months.
Exclusion
- \-
- Meeting any of the exclusion criteria at baseline will exclude participants from participation:
- Severe diabetes complications including end-stage renal failure, severe hypoglycemia and hyperglycemic crises within the last 1 month negating ability to fast,
- Pregnancy.
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT06033872
Start Date
January 25 2021
End Date
May 31 2022
Last Update
December 8 2023
Active Locations (1)
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1
Sengkang General Hospital
Singapore, Singapore