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Research ArticleOriginal Research

Efficacy and Safety of Use of the Fasting Algorithm for Singaporeans With Type 2 Diabetes (FAST) During Ramadan: A Prospective, Multicenter, Randomized Controlled Trial

Zheng Kang Lum, Zi Rui Khoo, Wei Yann See Toh, Shaikh Abdul Kader Kamaldeen, Abdul Shakoor, Keith Yu Kei Tsou, Daniel Ek Kwang Chew, Rinkoo Dalan, Sing Cheer Kwek, Noorani Othman, Joyce Xia Lian, Raden Nurheryany Bte Sunari and Joyce Yu-Chia Lee
The Annals of Family Medicine March 2020, 18 (2) 139-147; DOI: https://doi.org/10.1370/afm.2500
Zheng Kang Lum
1Department of Pharmacy, Faculty of Science, National University of Singapore
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Zi Rui Khoo
1Department of Pharmacy, Faculty of Science, National University of Singapore
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Wei Yann See Toh
2Department of Pharmacy, Tan Tock Seng Hospital, Singapore
PharmD, BCPS
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Shaikh Abdul Kader Kamaldeen
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Abdul Shakoor
3Department of Endocrinology, Tan Tock Seng Hospital, Singapore
MBBS, MD, MRCP
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Keith Yu Kei Tsou
4Department of Family Medicine, National University Polyclinics, Singapore
MBBCh, MMed, MCFP
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Daniel Ek Kwang Chew
3Department of Endocrinology, Tan Tock Seng Hospital, Singapore
MBBS, MRCP, FAMS
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Rinkoo Dalan
3Department of Endocrinology, Tan Tock Seng Hospital, Singapore
MBBS, MRCP, FAMS
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Sing Cheer Kwek
4Department of Family Medicine, National University Polyclinics, Singapore
MBBS, MMed
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Noorani Othman
3Department of Endocrinology, Tan Tock Seng Hospital, Singapore
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Joyce Xia Lian
3Department of Endocrinology, Tan Tock Seng Hospital, Singapore
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Raden Nurheryany Bte Sunari
1Department of Pharmacy, Faculty of Science, National University of Singapore
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Joyce Yu-Chia Lee
1Department of Pharmacy, Faculty of Science, National University of Singapore
2Department of Pharmacy, Tan Tock Seng Hospital, Singapore
PharmD, BCPS, BCACP
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  • For correspondence: j.lee@uci.edu
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  • Figure 1
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    Figure 1

    Flow diagram for trial participants.

  • Figure 2
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    Figure 2

    Trends of change in mean HbA1c level across pre-Ramadan, post-Ramadan, and 3-month follow-up timepoints.

  • Figure 3a
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    Figure 3a

    Trends of change in mean FBG levels across pre-Ramadan, post-Ramadan, and 3-month follow-up timepoints.

    ADA = American Diabetes Association; FBG = fasting blood glucose; PPG = postprandial glucose

    Changes in fasting blood glucose during the Ramadan period. The dotted line indicates the target cutoff for fasting blood glucose of 130 mg/dL, as defined by the ADA.

  • Figure 3b
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    Figure 3b

    Trends of change in mean PPG levels across pre-Ramadan, post-Ramadan, and 3-month follow-up timepoints.

    ADA = American Diabetes Association; FBG = fasting blood glucose; PPG = postprandial glucose

    Changes in postprandial glucose during the Ramadan period. The dotted line indicates the target cutoff for postprandial glucose of 180 mg/dL, as defined by the ADA.

Tables

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    Table 1

    Baseline Characteristics of Trial Participants (Per-Protocol Analysis)

    CharacteristicOverall (N = 97)aIntervention Group (n = 46)aControl Group (n = 51)aP Value
    Age, y, mean (SD)59.5 (11.2)59.8 (10.8)59.3 (11.7).811
    Sex, No. (%).022
     Male39 (40.2)24 (52.2)15 (29.4)
     Female58 (59.8)22 (47.8)36 (70.6)
    Ethnicity, No. (%).440
     Malay88 (90.7)43 (93.5)45 (88.2)
     Indian6 (6.2)2 (4.3)4 (7.8)
     Chinese1 (1.0)1 (2.2)0 (0)
     Other2 (2.1)0 (0)2 (3.9)
    Education level, No. (%).282
     No formal education4 (4.1)1 (2.2)3 (5.9)
     Elementary29 (29.9)13 (28.3)16 (31.4)
     High school43 (44.3)20 (43.5)23 (45.1)
     College/university21 (21.6)12 (26.1)9 (17.6)
    Days fasted during Ramadan, median (IQR)30 (26-30)30 (27-30)30 (26-30).896
    Duration of diabetes, y, median (IQR)10 (5.0-20.0)10 (5.0-15.0)11 (4.5-21.5).529
    Number of comorbidities, mean (SD)3.75 (1.24)3.72 (1.24)3.78 (1.25).793
    Diabetes regimen, No. (%).084
     Insulin only2 (2.1)2 (4.3)0 (0)
     Oral therapy only59 (60.8)31 (67.4)28 (54.9)
    Insulin and oral therapy36 (37.1)13 (28.3)23 (45.1)
    BMI, kg/m2, mean (SD)30.3 (5.5)29.7 (5.6)30.8 (5.4).352
    HbA1c, mean (SD).932
     %7.8 (0.9)7.8 (0.9)7.8 (0.9)
     mmol/mol62 (9.9)62 (9.9)62 (9.9)
    Fasting blood glucose, mg/dL, mean (SD)120.8 (28.9)123.7 (27.1)118.6 (32.5).283
    Postprandial glucose, mg/dL, mean (SD)196.4 (55.9)191.0 (41.5)201.8 (68.5).867
    Creatinine clearance, mL/min, mean (SD)60.3 (29.6)58.8 (30.1)61.7 (29.4).635
    • BMI = body mass index; HbA1c = glycated hemoglobin; IQR = interquartile range.

    • ↵a Data are presented as number (%) for categoric variables, mean (SD) for normally distributed continuous variables, and median (IQR) for nonnormally distributed continuous variables.

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    Table 2

    Safety Outcomes

    Intervention Group (n = 46)Control Group (n = 51)P Value
    Self-reported minor hypoglycemia eventa, No. (%)14 (30.4)15 (29.4).912
    Minor hypoglycemia event based solely on SMBG reading <72 mg/dL, No. (%)4 (8.7)6 (11.8).744
    Actual minor hypoglycemia eventb, No. (%)1 (2.2)5 (9.8).154
    • SMBG = self-monitoring of blood glucose.

    • ↵a Minor hypoglycemia event defined as signs and symptoms precipitated by known or modifiable causes and could be quickly self-managed with or without ingesting fast-acting glucose.

    • ↵b Actual minor hypoglycemia event defined as self-reported minor hypoglycemia and a corresponding objective SMBG reading of <72 mg/dL.

Additional Files

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  • The Article in Brief

    Efficacy and Safety of Use of the Fasting Algorithm for Singaporeans With Type 2 Diabetes (FAST) During Ramadan: A Prospective, Multicenter, Randomized Controlled Trial

    , and colleagues

    Background Most Muslims who have diabetes engage in intermittent fasting during Ramadan, yet there are concerns regarding how to safely manage diabetes while fasting. A study of fasting adults with type 2 diabetes found that those who managed their condition in collaboration with their health care provider using an empowerment-based approach, saw greater improvements in glycemic control. Health researchers from the University of California, Irvine and the National University of Singapore developed a collaborative diabetes management tool tailored for fasting Muslims and their doctors called FAST, or "Fasting Algorithm for Singaporeans with Type 2 Diabetes." The FAST tool sought to empower diabetic patients who fast with Ramadan-specific educational materials, dosing modification information for patients and their doctors, and encouragement of active self-monitoring of blood glucose before, during and after fasting.

    What This Study Found The FAST tool was evaluated for safety and effectiveness in a prospective, multi-center, randomized controlled trial with 111 fasting adults with type two diabetes in Singapore. Additionally, the FAST protocol did not increase the risk of hypoglycemic events. On average, those in the FAST intervention group showed four times the reduction in hemoglobin A1c compared to the control group (-0.4% vs -0.1%, 95% CI: -0.605 to - 0.001, p = 0.049), in measures taken before and after the fasting period. There were no major hypoglycemic events in either group, and no increase in minor hypoglycemic events in the FAST group.

    Implications

    • The researchers conclude that the use of empowerment-based, tailored tools for diabetes management like FAST can help observant Muslims with diabetes fast safely. According to the lead author, "This is one of the first tools that brings together Ramadan education, guidance for health care providers and elements of patient empowerment, which can be incorporated into standard practice guidelines and resulting in a global paradigm shift for diabetes management among Muslims who fast during Ramadan."
  • Supplemental PDF: Fasting Algorithm Flow Chart

    Supplemental Appendix

    Files in this Data Supplement:

    • Supplemental PDF: Fasting Algorithm Flow Chart - PDF file
  • Author audio interview

    Editor in Chief Caroline Richardson, MD chats with author Joyce Lee on religion and diabetes, and how her algorithm can support diabetic patients who fast during Ramadan.

    Files in this Data Supplement:

    • Audio interview with author - .mp3 file
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The Annals of Family Medicine: 18 (2)
The Annals of Family Medicine: 18 (2)
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March/April 2020
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Efficacy and Safety of Use of the Fasting Algorithm for Singaporeans With Type 2 Diabetes (FAST) During Ramadan: A Prospective, Multicenter, Randomized Controlled Trial
Zheng Kang Lum, Zi Rui Khoo, Wei Yann See Toh, Shaikh Abdul Kader Kamaldeen, Abdul Shakoor, Keith Yu Kei Tsou, Daniel Ek Kwang Chew, Rinkoo Dalan, Sing Cheer Kwek, Noorani Othman, Joyce Xia Lian, Raden Nurheryany Bte Sunari, Joyce Yu-Chia Lee
The Annals of Family Medicine Mar 2020, 18 (2) 139-147; DOI: 10.1370/afm.2500

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Efficacy and Safety of Use of the Fasting Algorithm for Singaporeans With Type 2 Diabetes (FAST) During Ramadan: A Prospective, Multicenter, Randomized Controlled Trial
Zheng Kang Lum, Zi Rui Khoo, Wei Yann See Toh, Shaikh Abdul Kader Kamaldeen, Abdul Shakoor, Keith Yu Kei Tsou, Daniel Ek Kwang Chew, Rinkoo Dalan, Sing Cheer Kwek, Noorani Othman, Joyce Xia Lian, Raden Nurheryany Bte Sunari, Joyce Yu-Chia Lee
The Annals of Family Medicine Mar 2020, 18 (2) 139-147; DOI: 10.1370/afm.2500
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