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| Name | Class |
|---|---|
| National University of Singapore | OTHER |
| Tan Tock Seng Hospital | OTHER |
| National Healthcare Group, Singapore | OTHER_GOV |
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Background: Ramadan fasting is a religious observance carried out by Muslims all over the world. During Ramadan, Muslims abstain from eating, drinking, and smoking during daylight hours. Although Muslims who are ill, including patients with diabetes, are exempted from fasting, many devoted Muslim patients still insist on fasting despite being advised not to by their healthcare providers. Concerns have been raised over how the practice of fasting may affect the metabolic control of Muslim patients with diabetes. Furthermore, it has also been postulated that the act of fasting may increase the risk of hypoglycemia or glucose toxicity. Although practice algorithms and suggestions on the use of glycemic therapies during fasting have been discussed internationally. they are not generalizable as the observances of Ramadan, duration of fasting and the food ingested differ from one country to another.
Aims: This study aims to develop and implement a clinical practice dose-adjustment algorithm dedicated to the care of Singaporean patients with diabetes who fast during Ramadan.
Hypothesis: The use of clinical practice dose-adjustment algorithm can improve both clinical and humanistic outcomes of patients with type 2 diabetes who wish to fast during Ramadan.
Methods: This is a prospective, randomized, interventional study involving patients with type 2 diabetes who wish to fast for at least 10 days during Ramadan. Eligible patient attending a primary care institution or an outpatient specialist clinic of a tertiary institution will be approached to participate in the study. Consented patients will be randomized to either intervention arm or control arm. Patients in the control arm will receive usual care while patients in the intervention arm will be given additional education session on Ramadan fasting related diabetic management advice and an algorithm that was developed by the study team members based on international guidelines, to guide them on self-management during Ramadan. The primary outcomes will be change in HbA1c. Secondary outcomes include change in fasting blood glucose, post prandial blood glucose, medication adherence and humanistic outcomes. The safety outcomes include self reported incidence of major and minor hypoglycemia as well as hyperglycemia during Ramadan month. All outcomes will be measured at baseline, during Ramadan and at 3 month post Ramadan.
Significance: The validation of the algorithm through this study will ensure effective and safe fasting of patients with type 2 diabetes during Ramadan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Other | FAST user |
|
| Control | Other | Standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAST | Other | Fasting Algorithm for Singaporeans with Type 2 Diabetes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change in HbA1c during and after Ramadan from baseline | Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of minor and major hypoglycemia | Incidence of minor hypoglycemia which is defined as signs and symptoms with known precipitating causes such as irregular eating habits, increased daily activity or other attributes that can be modified. Major hypoglycemia is defined as any hypoglycemic symptoms that require the help from another person. | During one month of Ramadan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee, Pharm D | National University of Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tan Tock Seng Hospital | Singapore | 308433 | Singapore | |||
| National Healthcare Group Polyclinic (Bukit Batok) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37435938 | Derived | Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care |
| Other |
Standard of care |
|
| Incidence of hyperglycemia | Incidence of hyperglycemia which is defined as signs and symptoms of frequent urination, increased thirst or fruity-smelling breath. | During one month of Ramadan |
| Change in fasting blood glucose (FPG) | Change in FPG during and after Ramadan from baseline | Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan) |
| Change in post-prandial blood glucose | Change in 2 hours post meal during and after Ramadan from baseline | Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan) |
| Change in blood pressure | Change in BP during and after Ramadan from baseline | Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan) |
| Change in lipid panel | including LDL, TG, TC, HDL | Baseline Pre-Ramadan (3 months prior to Ramadan) and post Ramadan (3 months after Ramadan) |
| Change in general health status | EQ-5D-5L | Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks) |
| Change in diabetes-related distress | Problem Area in Diabetes (PAID) | Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks) |
| Change in diabetes-specific quality of life | Audit of Diabetes Dependent Quality of Life (ADDQoL) | Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks) |
| Change in diabetes treatment satisfaction | Diabetes Treatment Satisfaction Questionnaires (DTSQ) | Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks) |
| Singapore |
| 659164 |
| Singapore |
| D004700 | Endocrine System Diseases |