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. 2023 Jul 12;7(7):CD013178.
doi: 10.1002/14651858.CD013178.pub2.

Interventions for people with type 2 diabetes mellitus fasting during Ramadan

Shaun Wen Huey Lee  1 , Won Sun Chen  2   3 , Renukha Sellappans  4 , Shakirah Binti Md Sharif  5 , Maria-Inti Metzendorf  6 , Nai Ming Lai  7
Affiliations

Interventions for people with type 2 diabetes mellitus fasting during Ramadan

Shaun Wen Huey Lee et al. Cochrane Database Syst Rev. .

Abstract

Background: Fasting during Ramadan is obligatory for adult Muslims, except those who have a medical illness. Many Muslims with type 2 diabetes (T2DM) choose to fast, which may increase their risks of hypoglycaemia and dehydration.

Objectives: To assess the effects of interventions for people with type 2 diabetes fasting during Ramadan.

Search methods: We searched CENTRAL, MEDLINE, PsycINFO, CINAHL, WHO ICTRP and ClinicalTrials.gov (29 June 2022) without language restrictions.

Selection criteria: Randomised controlled trials (RCTs) conducted during Ramadan that evaluated all pharmacological or behavioural interventions in Muslims with T2DM.

Data collection and analysis: Two authors screened and selected records, assessed risk of bias and extracted data independently. Discrepancies were resolved by a third author. For meta-analyses we used a random-effects model, with risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes with their associated 95% confidence intervals (CIs). We assessed the certainty of evidence using the GRADE approach.

Main results: We included 17 RCTs with 5359 participants, with a four-week study duration and at least four weeks of follow-up. All studies had at least one high-risk domain in the risk of bias assessment. Four trials compared dipeptidyl-peptidase-4 (DPP-4) inhibitors with sulphonylurea. DPP-4 inhibitors may reduce hypoglycaemia compared to sulphonylureas (85/1237 versus 165/1258, RR 0.53, 95% CI 0.41 to 0.68; low-certainty evidence). Serious hypoglycaemia was similar between groups (no events were reported in two trials; 6/279 in the DPP-4 versus 4/278 in the sulphonylurea group was reported in one trial, RR 1.49, 95% CI 0.43 to 5.24; very low-certainty evidence). The evidence was very uncertain about the effects of DPP-4 inhibitors on adverse events other than hypoglycaemia (141/1207 versus 157/1219, RR 0.90, 95% CI 0.52 to 1.54) and HbA1c changes (MD -0.11%, 95% CI -0.57 to 0.36) (very low-certainty evidence for both outcomes). No deaths were reported (moderate-certainty evidence). Health-related quality of life (HRQoL) and treatment satisfaction were not evaluated. Two trials compared meglitinides with sulphonylurea. The evidence is very uncertain about the effect on hypoglycaemia (14/133 versus 21/140, RR 0.72, 95% CI 0.40 to 1.28) and HbA1c changes (MD 0.38%, 95% CI 0.35% to 0.41%) (very low-certainty evidence for both outcomes). Death, serious hypoglycaemic events, adverse events, treatment satisfaction and HRQoL were not evaluated. One trial compared sodium-glucose co-transporter-2 (SGLT-2) inhibitors with sulphonylurea. SGLT-2 may reduce hypoglycaemia compared to sulphonylurea (4/58 versus 13/52, RR 0.28, 95% CI 0.10 to 0.79; low-certainty evidence). The evidence was very uncertain for serious hypoglycaemia (one event reported in both groups, RR 0.90, 95% CI 0.06 to 13.97) and adverse events other than hypoglycaemia (20/58 versus 18/52, RR 1.00, 95% CI 0.60 to 1.67) (very low-certainty evidence for both outcomes). SGLT-2 inhibitors result in little or no difference in HbA1c (MD 0.27%, 95% CI -0.04 to 0.58; 1 trial, 110 participants; low-certainty evidence). Death, treatment satisfaction and HRQoL were not evaluated. Three trials compared glucagon-like peptide 1 (GLP-1) analogues with sulphonylurea. GLP-1 analogues may reduce hypoglycaemia compared to sulphonylurea (20/291 versus 48/305, RR 0.45, 95% CI 0.28 to 0.74; low-certainty evidence). The evidence was very uncertain for serious hypoglycaemia (0/91 versus 1/91, RR 0.33, 95% CI 0.01 to 7.99; very low-certainty evidence). The evidence suggests that GLP-1 analogues result in little to no difference in adverse events other than hypoglycaemia (78/244 versus 55/255, RR 1.50, 95% CI 0.86 to 2.61; very low-certainty evidence), treatment satisfaction (MD -0.18, 95% CI -3.18 to 2.82; very low-certainty evidence) or change in HbA1c (MD -0.04%, 95% CI -0.45% to 0.36%; 2 trials, 246 participants; low-certainty evidence). Death and HRQoL were not evaluated. Two trials compared insulin analogues with biphasic insulin. The evidence was very uncertain about the effects of insulin analogues on hypoglycaemia (47/256 versus 81/244, RR 0.43, 95% CI 0.13 to 1.40) and serious hypoglycaemia (4/131 versus 3/132, RR 1.34, 95% CI 0.31 to 5.89) (very low-certainty evidence for both outcomes). The evidence was very uncertain for the effect of insulin analogues on adverse effects other than hypoglycaemia (109/256 versus 114/244, RR 0.83, 95% CI 0.44 to 1.56; very low-certainty evidence), all-cause mortality (1/131 versus 0/132, RR 3.02, 95% CI 0.12 to 73.53; very low-certainty evidence) and HbA1c changes (MD 0.03%, 95% CI -0.17% to 0.23%; 1 trial, 245 participants; very low-certainty evidence). Treatment satisfaction and HRQoL were not evaluated. Two trials compared telemedicine with usual care. The evidence was very uncertain about the effect of telemedicine on hypoglycaemia compared with usual care (9/63 versus 23/58, RR 0.42, 95% CI 0.24 to 0.74; very low-certainty evidence), HRQoL (MD 0.06, 95% CI -0.03 to 0.15; very low-certainty evidence) and HbA1c change (MD -0.84%, 95% CI -1.51% to -0.17%; very low-certainty evidence). Death, serious hypoglycaemia, AEs other than hypoglycaemia and treatment satisfaction were not evaluated. Two trials compared Ramadan-focused patient education with usual care. The evidence was very uncertain about the effect of Ramadan-focused patient education on hypoglycaemia (49/213 versus 42/209, RR 1.17, 95% CI 0.82 to 1.66; very low-certainty evidence) and HbA1c change (MD -0.40%, 95% CI -0.73% to -0.06%; very low-certainty evidence). Death, serious hypoglycaemia, adverse events other than hypoglycaemia, treatment satisfaction and HRQoL were not evaluated. One trial compared drug dosage reduction with usual care. The evidence is very uncertain about the effect of drug dosage reduction on hypoglycaemia (19/452 versus 52/226, RR 0.18, 95% CI 0.11 to 0.30; very low-certainty evidence). No participants experienced adverse events other than hypoglycaemia during the study (very low-certainty evidence). Death, serious hypoglycaemia, treatment satisfaction, HbA1c change and HRQoL were not evaluated.

Authors' conclusions: There is no clear evidence of the benefits or harms of interventions for individuals with T2DM who fast during Ramadan. All results should be interpreted with caution due to concerns about risk of bias, imprecision and inconsistency between studies, which give rise to low- to very low-certainty evidence. Major outcomes, such as mortality, health-related quality of life and severe hypoglycaemia, were rarely evaluated. Sufficiently powered studies that examine the effects of various interventions on these outcomes are needed.

Trial registration: ClinicalTrials.gov NCT01131182 NCT01340768 NCT01917656 NCT01758380 NCT02648217 NCT02941367 NCT02189135 NCT03314246 NCT02694263.

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Conflict of interest statement

Shaun Wen Huey Lee (SWHL): was the lead author of two of the included studies (Lee 2015; Lee 2017a). However, he was not involved in the selection and risk of bias assessment of these studies. He has no other known conflicts of interest.

Nai Ming Lai (NML): no known conflicts of interest.

Won Sun Chen (WSC): no known conflicts of interest.

Renukha Sellappans (RS): no known conflicts of interest.

Shakirah Binti Md Sharif (SBMS): no known conflicts of interest.

Maria‐Inti Metzendor (MIM): no known conflicts of interest. MIM is an Information Specialist for Cochrane Metabolic and Endocrine Disorders, but she was excluded from the editorial processing of this article.

Figures

1
1
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies (blank cells indicate that the particular outcome was not measured in some studies).
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study (blank cells indicate that the particular outcome was not measured in some studies).
1.1
1.1. Analysis
Comparison 1: DPP‐4 inhibitors vs sulphonylureas, Outcome 1: Hypoglycaemic episodes
1.2
1.2. Analysis
Comparison 1: DPP‐4 inhibitors vs sulphonylureas, Outcome 2: Serious hypoglycaemia
1.3
1.3. Analysis
Comparison 1: DPP‐4 inhibitors vs sulphonylureas, Outcome 3: Adverse events other than hypoglycaemia
1.4
1.4. Analysis
Comparison 1: DPP‐4 inhibitors vs sulphonylureas, Outcome 4: All‐cause mortality
1.5
1.5. Analysis
Comparison 1: DPP‐4 inhibitors vs sulphonylureas, Outcome 5: HbA1c
1.6
1.6. Analysis
Comparison 1: DPP‐4 inhibitors vs sulphonylureas, Outcome 6: Body weight
1.7
1.7. Analysis
Comparison 1: DPP‐4 inhibitors vs sulphonylureas, Outcome 7: Body mass index
1.8
1.8. Analysis
Comparison 1: DPP‐4 inhibitors vs sulphonylureas, Outcome 8: Fasting plasma glucose
2.1
2.1. Analysis
Comparison 2: Meglitinides vs sulphonylureas, Outcome 1: Hypoglycaemic episodes
2.2
2.2. Analysis
Comparison 2: Meglitinides vs sulphonylureas, Outcome 2: HbA1c
2.3
2.3. Analysis
Comparison 2: Meglitinides vs sulphonylureas, Outcome 3: Serum fructosamine
3.1
3.1. Analysis
Comparison 3: SGLT‐2 inhibitors vs sulphonylureas, Outcome 1: Hypoglycaemic episodes
3.2
3.2. Analysis
Comparison 3: SGLT‐2 inhibitors vs sulphonylureas, Outcome 2: Serious hypoglycaemia
3.3
3.3. Analysis
Comparison 3: SGLT‐2 inhibitors vs sulphonylureas, Outcome 3: Adverse events other than hypoglycaemia
3.4
3.4. Analysis
Comparison 3: SGLT‐2 inhibitors vs sulphonylureas, Outcome 4: HbA1c
3.5
3.5. Analysis
Comparison 3: SGLT‐2 inhibitors vs sulphonylureas, Outcome 5: Serum fructosamine
3.6
3.6. Analysis
Comparison 3: SGLT‐2 inhibitors vs sulphonylureas, Outcome 6: Fasting plasma glucose
4.1
4.1. Analysis
Comparison 4: GLP‐1 analogues vs sulphonylureas, Outcome 1: Hypoglycaemic episodes
4.2
4.2. Analysis
Comparison 4: GLP‐1 analogues vs sulphonylureas, Outcome 2: Serious hypoglycaemia
4.3
4.3. Analysis
Comparison 4: GLP‐1 analogues vs sulphonylureas, Outcome 3: Adverse events other than hypoglycaemia
4.4
4.4. Analysis
Comparison 4: GLP‐1 analogues vs sulphonylureas, Outcome 4: Treatment satisfaction
4.5
4.5. Analysis
Comparison 4: GLP‐1 analogues vs sulphonylureas, Outcome 5: HbA1c
4.6
4.6. Analysis
Comparison 4: GLP‐1 analogues vs sulphonylureas, Outcome 6: Total cholesterol
4.7
4.7. Analysis
Comparison 4: GLP‐1 analogues vs sulphonylureas, Outcome 7: Triglycerides
4.8
4.8. Analysis
Comparison 4: GLP‐1 analogues vs sulphonylureas, Outcome 8: Body weight change
4.9
4.9. Analysis
Comparison 4: GLP‐1 analogues vs sulphonylureas, Outcome 9: Serum fructosamine
5.1
5.1. Analysis
Comparison 5: Insulin analogues vs biphasic insulin, Outcome 1: Hypoglycaemic episodes
5.2
5.2. Analysis
Comparison 5: Insulin analogues vs biphasic insulin, Outcome 2: Serious hypoglycaemia
5.3
5.3. Analysis
Comparison 5: Insulin analogues vs biphasic insulin, Outcome 3: Adverse events other than hypoglycaemia
5.4
5.4. Analysis
Comparison 5: Insulin analogues vs biphasic insulin, Outcome 4: All‐cause mortality
5.5
5.5. Analysis
Comparison 5: Insulin analogues vs biphasic insulin, Outcome 5: HbA1c
5.6
5.6. Analysis
Comparison 5: Insulin analogues vs biphasic insulin, Outcome 6: Total cholesterol
5.7
5.7. Analysis
Comparison 5: Insulin analogues vs biphasic insulin, Outcome 7: Low‐density lipoprotein
5.8
5.8. Analysis
Comparison 5: Insulin analogues vs biphasic insulin, Outcome 8: High‐density lipoprotein
5.9
5.9. Analysis
Comparison 5: Insulin analogues vs biphasic insulin, Outcome 9: Triglycerides
5.10
5.10. Analysis
Comparison 5: Insulin analogues vs biphasic insulin, Outcome 10: Serum fructosamine
6.1
6.1. Analysis
Comparison 6: Telemedicine vs usual care, Outcome 1: Hypoglycaemic episodes
6.2
6.2. Analysis
Comparison 6: Telemedicine vs usual care, Outcome 2: Health‐related quality of life
6.3
6.3. Analysis
Comparison 6: Telemedicine vs usual care, Outcome 3: HbA1c
6.4
6.4. Analysis
Comparison 6: Telemedicine vs usual care, Outcome 4: Systolic blood pressure
6.5
6.5. Analysis
Comparison 6: Telemedicine vs usual care, Outcome 5: Diastolic blood pressure
6.6
6.6. Analysis
Comparison 6: Telemedicine vs usual care, Outcome 6: Total cholesterol
6.7
6.7. Analysis
Comparison 6: Telemedicine vs usual care, Outcome 7: Low‐density lipoprotein
6.8
6.8. Analysis
Comparison 6: Telemedicine vs usual care, Outcome 8: High‐density lipoprotein
6.9
6.9. Analysis
Comparison 6: Telemedicine vs usual care, Outcome 9: Triglyceride levels
6.10
6.10. Analysis
Comparison 6: Telemedicine vs usual care, Outcome 10: Body weight change
6.11
6.11. Analysis
Comparison 6: Telemedicine vs usual care, Outcome 11: Body mass index change
6.12
6.12. Analysis
Comparison 6: Telemedicine vs usual care, Outcome 12: Diabetes self‐efficacy
6.13
6.13. Analysis
Comparison 6: Telemedicine vs usual care, Outcome 13: Diabetes‐related distress
6.14
6.14. Analysis
Comparison 6: Telemedicine vs usual care, Outcome 14: Serum fructosamine
6.15
6.15. Analysis
Comparison 6: Telemedicine vs usual care, Outcome 15: Fasting plasma glucose
7.1
7.1. Analysis
Comparison 7: Patient education versus usual care, Outcome 1: Hypoglycaemic episodes
7.2
7.2. Analysis
Comparison 7: Patient education versus usual care, Outcome 2: HbA1c
7.3
7.3. Analysis
Comparison 7: Patient education versus usual care, Outcome 3: Fasting plasma glucose
7.4
7.4. Analysis
Comparison 7: Patient education versus usual care, Outcome 4: Body weight
8.1
8.1. Analysis
Comparison 8: Drug dosage reduction versus usual care, Outcome 1: Hypoglycaemic episodes
8.2
8.2. Analysis
Comparison 8: Drug dosage reduction versus usual care, Outcome 2: Adverse events other than hypoglycaemia
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References

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NCT02694263 {published data only}
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Prataksitorn 2014 {published data only}
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References to studies awaiting assessment

Aghili 2012 {published data only}
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Mohamad 2018 {published data only}
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References to other published versions of this review

Lee 2018
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Publication types

Associated data