Diabetes Mellitus, Type 2FASTNCT03314246
Development and Implementation of Ramadan Fasting Algorithm for Singaporeans With Type 2 Diabetes
A study testing FAST in people with Diabetes Mellitus, Type 2, run by Joyce Lee at 2 sites in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- FAST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 2 sitesSingapore
- Study dates
- 3 Apr 2017to 6 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Muslim patients over 21 years of age with Type 2 diabetes who plan to fast for at least 10 days during the month of Ramadan
Who cannot join
- Patients with history of recurrent hypoglycemia
- Patients who are pregnant
- Patients with eGFR<30ml/min 3 months prior to Ramadan
- Patients with HbA1c > 9.5%
- Patients with DM-related admission 1 month prior to Ramadan
- Patients on active short-term corticosteroid treatment
- Patients who are unable to complete the questionnaires
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Tan Tock Seng Hospital
Singapore, 308433
National Healthcare Group Polyclinic (Bukit Batok)
Singapore, 659164
About this study
Official title: Development and Implementation of Ramadan "Fasting Algorithm for Singaporeans With Type 2 Diabetes" (FAST): A Prospective Randomized Controlled Intervention Study
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.
Read more
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- FAST, Standard of care
- Keywords
- Diabetes Mellitus, Type 2, Ramadan Fasting, Randomized controlled trial
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FASTOther
Fasting Algorithm for Singaporeans with Type 2 Diabetes
Standard of careOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | FAST user Receives: Other: FAST |
| Control | Other | Standard of care Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change in HbA1c during and after Ramadan from baseline
Measured: Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
Secondary outcomes (10)
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.
Measured: During one month of Ramadan
Incidence of hyperglycemia
Incidence of hyperglycemia which is defined as signs and symptoms of frequent urination, increased thirst or fruity-smelling breath.
Measured: During one month of Ramadan
Change in fasting blood glucose (FPG)
Change in FPG during and after Ramadan from baseline
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline Pre-Ramadan (3 months prior to Ramadan) and post Ramadan (3 months after Ramadan)
Change in general health status
EQ-5D-5L
Measured: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
Change in diabetes-related distress
Problem Area in Diabetes (PAID)
Measured: 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)
Measured: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
Change in diabetes treatment satisfaction
Diabetes Treatment Satisfaction Questionnaires (DTSQ)
Measured: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start3 Apr 2017
- Primary completion6 Feb 2019
- Study completion6 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joyce Lee
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore, Tan Tock Seng Hospital, National Healthcare Group, Singapore
- Responsible party
- Sponsor-investigator, Joyce Lee, National University of Singapore
- Investigators
- Lee, Pharm D, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314246
- Sponsor's protocol ID
- 2016/00290
- Other IDs
- 2016
- Acronym
- FAST
- Status last verified
- Feb 2020
- First submitted
- 20 Sep 2017
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37435938
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of Ramadan "Fasting Algorithm for Singaporeans With Type 2 Diabetes" (FAST): A Prospective Randomized Controlled Intervention Study
- ClinicalTrials.gov ID
- NCT03314246
- Acronym / sponsor ID
- FAST / 2016/00290
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Ramadan Fasting, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Joyce LeeUniversity, hospital or other
- Collaborators
- National University of Singapore, Tan Tock Seng Hospital, National Healthcare Group, Singapore
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 19 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: FASTFAST user |
| Control | Other | Other: Standard of careStandard of care |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All Muslim patients over 21 years of age with Type 2 diabetes who plan to fast for at least 10 days during the month of Ramadan
Key exclusion criteria (7 listed)
- Patients with history of recurrent hypoglycemia
- Patients who are pregnant
- Patients with eGFR<30ml/min 3 months prior to Ramadan
- Patients with HbA1c > 9.5%
- Patients with DM-related admission 1 month prior to Ramadan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FASTFasting Algorithm for Singaporeans with Type 2 Diabetes | Other | Intervention |
| Standard of careStandard of care | Other | Control |
Primary outcome
Change in HbA1c
Time frame: Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
Change in HbA1c during and after Ramadan from baseline
10 secondary outcomes
Incidence of minor and major hypoglycemia
Time frame: During one month of Ramadan
Incidence of hyperglycemia
Time frame: During one month of Ramadan
Change in fasting blood glucose (FPG)
Time frame: 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
Time frame: Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
Change in blood pressure
Time frame: Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
Change in lipid panel
Time frame: Baseline Pre-Ramadan (3 months prior to Ramadan) and post Ramadan (3 months after Ramadan)
Change in general health status
Time frame: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
Change in diabetes-related distress
Time frame: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
Change in diabetes-specific quality of life
Time frame: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
Change in diabetes treatment satisfaction
Time frame: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Derived from this study: PubMed 37435938Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee, Pharm D principal investigator
National University of Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAST in people with Diabetes Mellitus, Type 2, run by Joyce Lee at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03314246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.