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©The Author(s) 2023.
World J Diabetes. Jun 15, 2023; 14(6): 892-918
Published online Jun 15, 2023. doi: 10.4239/wjd.v14.i6.892
Published online Jun 15, 2023. doi: 10.4239/wjd.v14.i6.892
Ref. | Country | Study design | Study time span | Population | Sample size (n) | No. of patients with DM (n) T1DM T2DM | Sex (F/M) | Age, median (min-max), yr | Type and name of vaccine | Dose schedule | Related findings | |
Zhang et al[23] | China | Observational study | Between October 2021 and January 2022 | The population is aged ≥ 60 yr with hypertension or (/and) DM | 1413 | 620 | 661/752 | 67.6 | Vero cell (19nCov-CDC-Tan-HB02) | Two doses (day 0, day 28) | After vaccination, there was no significant abnormal fluctuation in blood glucose in diabetic patients | |
Marfella et al[24] | Italy | Prospective observational study | December 2020 | Healthcare and educator workers | 478 | 201 | 212/266 | 18-60 | mRNA-BNT162b2 (Pfizer-BioNTech) or ChAdOx1-S (Astra-Zeneca) or mRNA-1273 (Moderna) | One (day 0, day 21) or two (day 52) doses | Significant decrease in the immune response in people with poorly controlled blood glucose | |
Kılınç-Toker et al[25] | Turkey | Retrospective study | Between August 1, 2021 and October 31, 2021 | Hospitalized patients with COVID-19 | 541 | 195 | 282/259 | 70.2 (21-98) | (CoronaVac) and/or BNT162b2 mRNA (Pfizer-BioNTech) | 14 d after dose 2 | For hospitalized patients after the second dose, diabetes was not associated with their ICU stay and mortality | |
Barocci et al[26] | Italy | Observational study | Between December 2020 and June 2021 | Healthcare workers and university staff | 2845 | 8 | 155/129 | 43-61 | ChAdOx1-S and (BNT162b2/BNT162b2 and ChAdOx1-S/ChAdOx1-S) | 2 mo after dose 2 | DM does not affect antibody levels | |
Singh et al[27]1 | India | Cross-sectional study | Between January 16, 2021 and May 15, 2021 | Healthcare workers | 5154 | 0 | 52 | 210/305 | 44.8 ± 13.19 | CovishieldTM (ChAdOx1-nCOV) or CovaxinTM (BBV-152) | One (day 21) and two (day 21-28, day 83-97, and day 173-187) doses | People with T2DM had a significantly lower seropositivity rate compared to those without |
Singh et al[28]1 | India | Longitudinal study | Between January 16, 2021 and November 15, 2021 | Healthcare workers | 481 | 0 | 51 | 195/286 | ≤ 60 years, n = 411; > 60 years, n = 70 | CovishieldTM (ChAdOx1-nCOV) or CovaxinTM (BBV-152) | 3 wk, 3 mo, and 6 mo after dose 2 | Participants with T2DM have a lower seropositivity rate at all time points |
Shim et al[29] | Korea | Retrospective study | February2021 | Vaccination participants | 736 | 48 | 433/303 | 51.5 (20-80) | AZD1222, BNT162b2, mRNA-1273 and Ad26.COV2.S | 2 wk before and 6 mo after dose 2 | Diabetics had a lower rate of neutralizing antibodies after vaccination | |
Alqassieh et al[30] | Jordan | Prospective observational cohort | Between March and April 2021 | Jordanian adults | 288 | 76 | 189/151 | 20-60 years, n = 137, > 60 years, n = 151 | Pfizer-BioNTech or Sinopharm | 6 wk after dose 2 | Although DM negatively affected IgG titer, it was not statistically significant | |
Wan et al[31] | China (Hong Kong) | Population-based study | Between February 23, 2021 and January 31, 2022 | Patients with T2DM in Hong Kong electronic case records | 350963 | 0 | 350963 | 167073/183890 | 64.7 ± 1.37/68.1 ± 0.747 | BNT162b2 or CoronaVac | Complete at least one dose of vaccination | Patients with T2DM do not appear to have higher risks of AESI and acute diabetic complications after vaccination |
Lee et al[32] | South Korea | Questionnaire study | Between March 8, 2021 and March 11, 2021 | Healthcare workers | 1603 | 27 | 1261/342 | 37.7 ± 10.89 | ChAdOx1 | 7 d after dose 1 | DM is associated with an increased risk of grade 3 to 4 adverse reactions after the first dose | |
Rangsrisaeneepitak et al[33] | Thailand | PSM observational study | Between June 8, 2021 and July 12, 2021 | Healthcare workers and T2DM patients | 282 | 94 | 129/153 | 30-83 | ChAdOx1 nCoV-19 (AZD1222) | 56 d after dose 1 | People with T2DM had weaker antibody responses than those without diabetes after the first dose | |
Sourij et al[34] | Austria | Multicentre prospective cohort study | Between April and June 2021 | T1DM, T2DM, and healthy participants | 150 | 75 | 75 | 68/82 | 49.2 ± 14.59 | BioNTech-Pfizer, Moderna, or AstraZeneca | 7 to 14 d after dose 1 and 14 to 21 dafter dose 2 | The antibody levels after the second vaccination were comparable in healthy controls and DM patients, irrespective of glycaemic control |
Tawinprai et al[35] | Thailand | Prospective cohort study | Between March 31, 2021 and May 5, 2021 | Healthcare workers | 796 | 11 | 517/279 | 40 (30-57)3 | ChAdOx1 (AZD1222) | At least 21 d after dose 1 and before dose 2 | DM reduces the immune response to vaccination | |
Ali et al[18] | Kuwait | Case-control study | August 2021 | Non-diabetics and patients with T2DM | 262 | 0 | 81 | 126/136 | 49.3 ± 14.59 | BNT162b2 (Pfizer-BioNTech) | At least 3 wk after dose 2 | Both neutralizing antibody and IgG antibody titers were significantly lower in the T2DM group than in the non-diabetic group |
Karamese et al[36] | Turkey | Descriptive study | March 2021 | Participants over 65 years of age who have received two doses of vaccine | 235 | 49 | 111/124 | 70.4 ± 4.89 | CoronaVac | 4 wk after dose 1 and 4 wk after dose 2 | Lower rates of antibody response were detected in participants with DM | |
Lustig et al[37] | Israel | Single-centre, prospective, longitudinal cohort study | Between December 19, 2020 and January 30, 2021 | Health-care workers | 2607 | 139 | 1883/724 | 47.7 ± 12.59 | Pfizer-BioNTech BNT162b2 | 1-2 wk after dose 1 and 1-2 wk after dose 2 | Decreased antibody response in diabetic patients after vaccination | |
Islam et al[38] | Japan | Cross-sectional study | June 2021 | Workers | 953 | 21 | 654/299 | 21-75 | BNT162b2 (Pfizer-BioNTech) | 15 to 71 d after dose 2 | Spike IgG antibody titers were lower in the presence of hyperglycemia | |
Parthymou et al[39] | Greece | Longitudinal observational cohort study | September 2021 | Healthcare units participants | 712 | 50 | 444/268 | 50.8 ± 11.49 | BNT162b2 (BioNTech-Pfizer) | 3 wk and 3 mo after Dose2 | DM is not an independent factor affecting antibody titers | |
Priddy et al[40] | New Zealand | Prospective cohort study | Between June 10, 2021 and September 18, 2021 | Participants in two centers | 285 | 28 | 156/1296 | 52 (16-92) | BNT162b2 (BioNTech-Pfizer) | 28 d after dose 2 | Participants with diabetes had lower anti-S IgG antibodies compared to those without DM | |
Naschitz et al[41] | Israel | Retrospective study | May 2021 | Residents in long-term geriatric and palliative care and assisted living facilities | 304 | 103 | 208/96 | ≥ 60 | BNT162b2 (Pfizer-BioNTech) | 3-4 mo after dose 2 | DM is associated with negative serological results | |
Güzel et al[42] | Turkey | Prospective study | May 20212 | Volunteers, outpatient clinic people, and COVID-19 patients | 183 | 80 | 98/85 | 21-60 | CoronaVac-SinoVac | 21 d after dose 2 | IgG antibody levels were significantly lower in patients with DM than in those without DM | |
Virgilio et al[43] | Italy | Multicenter prospective study | Between June 2021 and December 2021 | Residents of long-term care facilities | 555 | 0 | 140 | 378/177 | 82.1 | BNT162b2 (Cominarty) Moderna (mRNA-1273) | Before the vaccination, 2 mo, and 6 mo after dose 1 | Vaccination in elderly residents with T2DM is associated with a reduced humoral immune response |
Patalon et al[44] | Israel | Retrospective cohort study | Between February and May 2021 | A large patient cohort from Maccabi Healthcare Services | 4740 | 377 | 1914/2826 | 16-59 years, n = 3355; ≥ 60 years, n = 1385 | BNT162b2 (BioNTech-Pfizer) | Two vaccinations at intervals of 21 to 27 d | DM is not a relevant factor affecting antibody levels | |
Mitsunaga et al[45] | Japan | Prospective study | Between April 15, 2021 and June 9, 2021 | Hospital’s workers | 374 | 6 | 264/110 | 36 | BNT162b2 vaccine (COMIRNATY (Tozinameran) | Before vaccination, 7 to 20 d after dose 1, and 7 to 20 d after dose 2 | HbA1c higher than 6.5% was a significant suppressor of antibody responses | |
Papadokostaki et al[46] | Greece | Prospective observational study | Between May and September 2021. | Participants attended the vaccination center | 174 | 14 | 44 | 107/67 | 52.6 ± 10.6 | BNT162b2 (BioNTech-Pfizer) | 21 d after dose 1, 7-15 d after dose 2, and 70-75 d after dose 2 but before dose 3 | It was high and similar after the second dose in both participants with and without DM |
Zhao et al[47] | United States | Prospective longitudinal study | Between December 2020 and December 2021 | Veterans and healthcare workers | 124 | 39 | 33/91 | 20-95 | BNT162b2 (Pfizer-BioNTech) | 48 h before dose 1 and dose 2, 1 mo, 3 mo, 6 mo, 12 mo after dose 2, and 1 mo after dose 3 | DM was significantly associated with a decrease in response intensity after completion of the primary vaccine series, but responses to the third dose were generally robust | |
Santotoribio et al[48] | Spain | Descriptive, retrospective, observational, and cross-sectional study | Between November 1, 2020 and March 31, 2021 | Infected patients and vaccinated subjects | 175 | 17 | 112/63 | 51.0 (19-89) | Pfizer-BioNTech | At least 21 d after dose 2 | Serum antibody levels did not decrease significantly in patients with DM | |
Mehta et al[49] | India | Observational cohort study | Between March 2021 and October 2021 | Vaccinated patients with AIRDs | 495 | 63 | 416/79 | 56.5 | AZD1222 (AstraZeneca) | 4 wk and10-14 wk after dose 2 | DM was significantly associated with lower anti-RBD antibodies | |
Ajlan et al[50] | Saudi Arabia | PSM prospective study | June 14, 20222 | Patients from a large hospital | 431 | 191 | 136/295 | 51.3 ± 16.29 | BNT162b2 or ChAdOx1 | 7 d after dose 1 and dose 2, and 2 wk after dose 1 and dose 2 | There was no difference in the primary outcome between the two vaccine platforms. Unresponsiveness was mainly linked to DM | |
Billany et al[51] | United Kingdom | Prospective observational study | March 2021 | Maintenance hemodialysis patients | 94 | 43 | 38/56 | 62.1 ± 12.29 | BNT162b2 or AZD1222 | 28 d after dose 1 | There was no difference in antibody testing with or without DM | |
Aberer et al[52] | Austria | Multicenter prospective study | Between April and June 2021 | DM patients | 74 | 58 | 16 | NR | T1DM: 39.5 ± 14.1; T2DM: 60.6 ± 6.2 | BioNTech-Pfizer and Moderna and AstraZeneca | First dose | No change in insulin dose before and after vaccination. Vaccination significantly reduced TIR in T1DM patients, but had no effect on TIR in T2DM patients |
Piccini et al[53] | Italy | Observational cohort study | Between March and June 2021 | T1DM patients | 39 | 39 | 0 | 17/22 | 18.7 ± 2.19 | mRNA-BNT162b1 (Pfizer-BioNTech) and Moderna (mRNA-1273) | One (day 7, day 14) and two (day 7, day 14) doses and 14 d after dose 1 and dose 2 | COVID-19 vaccination was safe and not associated with significant perturbation of glycemic control in patients with T1DM |
Heald et al[54]1 | United Kingdom | Observational cohort study | Between January 14, and March 7, 2021 | T1DM patients | 20 | 20 | 0 | 11/9 | 53 (26-70) | mRNA-BNT162b2 (Pfizer-BioNTech) and Oxford /AstraZeneca | 7 d before and 7 d after dose 1 | COVID-19 vaccination can cause temporary relative hyperglycemia in people with T1DM. No relationship between vaccine type and blood glucose perturbation |
D'Onofrio et al[55] | Italy | Observational cohort study | July 13, 20212 | T1DM (AD) patients | 35 | 35 | 14/21 | 36 (27-51)3 | mRNA-BNT162b2 (Comirnaty) | 14 d before and 3 d after dose 1 and dose 2 | No significant differences in TIR, TAR, TBR, and CV between, after, and before the COVID-19 vaccination in T1DM patients | |
Heald et al[56]1 | United Kingdom | Survey and evaluation study | Between January 5, 2021 and April 4, 2021 | Adults (18 years of age or more) with T1DM | 97 | 97 | 0 | 51/46 | 44 (18-70) | Pfizer-BioNTech or Oxford-AstraZeneca | 7 d before and 7 dafter dose 1 | In T1DM, vaccination can cause a temporary perturbation of interstitial glucose. There is no difference between vaccines |
Gouda et al[57] | Greece | Observational study | March 2022 | T1DM patients | 1358 | 135 | 0 | 72/63 | 11.7 (5-18) | BNT162b2 (Pfizer-BioNTech), Moderna (mRNA-1273), or AstraZeneca | 7 d before and 7 d after dose 1, dose 2, and dose 3 | SARS-CoV-2 vaccination in children and adolescents with T1DM is safe and is not associated with immediate glucose imbalance |
Sakurai et al[58] | Japan | Case report | December 11, 20212 | Healthy woman | 1 | 1/0 | 36 | mRNA-BNT162b2 (Pfizer-BioNTech) | First dose | mRNA vaccine is associated with new-onset T1DM | ||
Patrizio et al[59] | Italy | Case report | September 15, 20212 | T2DM patient | 1 | 0 | 1 | 0/1 | 52 | mRNA-BNT162b2 (Pfizer-BioNTech) | Second dose | T1DM may be triggered after SARS-CoV-2 vaccination |
Aydoğan et al[60] | Turkey | Case series | Between May 2021 and October 2021 | One had Hashimoto's thyroiditis, and the other 3 were healthy | 4 | 1/3 | 27-56 | mRNA-BNT162b2 (Pfizer-BioNTech) or CoronaVac | Second dose | Vaccination with BNT162b2 may trigger T1DM | ||
Sato et al[61] | Japan | Case report | April 19, 20222 | Malignant melanoma patient | 1 | 0/1 | 43 | mRNA-based SARS-CoV-2 vaccination | Second dose | mRNA vaccine may trigger T1DM | ||
Yakou et al[62] | Japan | Case series | December 21, 20212 | T1DM patients | 2 | 2 | 0 | 2/0 | 52-71 | mRNA-BNT162b2 (Pfizer-BioNTech) | Second dose | A temporary decrease in insulin secretion after vaccination |
Mishra et al[63] | India | Case series | Between January 18, 2021 and March 4, 2021 | T2DM patients | 3 | 0 | 3 | 1/2 | 58-65 | Covishield™ (ChAdOx1-nCOV) (AstraZeneca) | First dose | Vaccination may result in a mild and temporary increase in blood glucose levels |
Abu-Rumaileh et al[64] | Jordan | Case report | January 14, 2021 | Hypertension patient | 1 | 0/1 | 58 | mRNA-BNT162b1 (Pfizer-BioNTech) | Second dose | COVID-19 vaccine has a risk of causing new-onset T2DM | ||
Sasaki et al[65] | Japan | Case report | December 13, 20212 | Osteoporosis, mild glucose intolerance | 1 | 0 | 0 | 1/0 | 73 | Moderna (Spikevax, mRNA-1273) | Second dose | The development of T1DM is attributable to the COVID-19 vaccination |
Lee et al[66] | United States | Case Series | June 30, 20212 | T2DM and hypertension patients | 3 | 0 | 2 | 1/2 | 52-87 | mRNA-BNT162b1 (Pfizer-BioNTech) and Moderna (Spikevax, mRNA-1273) | First dose | Vaccination may trigger a hyperglycemic episode and DKA |
Edwards et al[67] | United Kingdom | Case Series | April 2021 | Hypertension, hypothyroidism, and pre-diabetes | 3 | 0/3 | 53-68 | Covishield™ (ChAdOx1-nCOV) | First dose | The first administration of the COVID-19 vaccine can trigger an acute hyperglycemic crisis | ||
Ganakumar et al[68] | India | Case series | November 2021 | T1DM | 2 | 2 | 0 | 1/1 | 20-25 | COVISHIELD (ChAdOx1 nCoV-19) or COVAXIN (BBV152) | 1 to 4 d after dose 2 | COVID-19 Vaccination has the potential to induce DKA |
Zilbermint et al[69] | United States | Case report | September 11, 20212 | T1DM | 1 | 1 | 0 | 1/0 | 24 | Moderna (mRNA-1273) | 15 h after dose 2 | A plausible mechanism exists between COVID-19 vaccination and DKA |
Yaturu et al[70] | United States | Case report | May 2021 | Hypertension, primary hyperparathyroidism, and obesity patient | 1 | 0 | 1 | 0/1 | 56 | BNT162b2 (Pfizer-BioNTech) | Right after the second dose | COVID-19 Vaccination has the potential to induce HHS |
Kshetree et al[71] | United States | Case report | NR | Hypertension and pre-diabetes | 1 | 1 | 0 | 0/1 | 69 | mRNA vaccine | 2 mo after dose 3 | COVID-19 mRNA vaccine has the potential to induce DKA |
Prasad[72] | India | Case report | March 2021 | Patient with T2DM | 1 | 0 | 1 | 1/0 | 73 | Covishield | 6 d after dose 1 | Vaccination may cause glycaemic disturbances |
Sasaki et al[73] | Japan | Case report | January 4, 20222 | Healthy person | 1 | 1 | 0 | 1/0 | 45 | BNT162b2 (Pfizer-BioNTech) | 1 d after dose 1 | COVID-19 vaccine might trigger the onset of fulminant T1DM in susceptible individuals |
Yano et al[74] | Japan | Case report | November 11, 20212 | Healthy person | 1 | 1 | 0 | 1/0 | 51 | Moderna (mRNA-1273) | 28 d after dose 1 | COVID-19 vaccination can induce T1DM in some individuals |
Ohuchi et al[75] | Japan | Case report | November 20212 | Cutaneous malignant melanoma with axillary lymph node metastasis | 1 | 1 | 0 | 0/1 | 45 | BNT162b2 (Pfizer-BioNTech) | 3 d after dose 2 | There is a highly suspicious causal relationship between fulminant T1DM and COVID-19 vaccination |
Ref. | Age (yr) | Gender | Type and name of vaccine | Blood glucose (mg/dL)/HbA1c (%) pre-vaccination post-vaccination | Onset after vaccination | Pre-existing condition | Final diagnosis | C-peptide (ng/mL) | GAD65Ab (IU/mL) | Treatment | Outcomes | Conclusion | |
Sakurai et al[58] | 36 | Female | mRNA-BNT162b2 (Pfizer-BioNTech) | Normal | 501/7.0 | 3 d after dose 1 | None | Fulminant T1DM | 0.13 | NA | Insulin infusion | Discharged | mRNA vaccine is associated with new-onset T1DM |
Patrizio et al[59] | 52 | Male | mRNA-BNT162b2 (Pfizer-BioNTech) | 531 | 871 | 4 wk after dose 2 | Vitiligo vulgaris and T2DM | Graves’ disease and T1DM | 1 | 61.2 | Insulin analogues | NR | T1DM may be triggered after SARS-CoV-2 vaccination |
Aydoğan et al[60] | 56 | Male | mRNA-BNT162b1 (Pfizer-BioNTech) | Normal | 440/8.2 | 15 d after dose 2 | Vitiligo vulgaris and Hashimoto's thyroiditis | T1DM | 1.5 | > 2000 | Insulin infusion | Recovery | Vaccination with BNT162b2 may trigger T1DM |
48 | Male | mRNA-BNT162b2 (Pfizer-BioNTech) | Normal | 352/10.1 | 8 wk after dose 2 | None | T1DM | 0.97 | 94 | Low-carbohydrate diet | Recovery | ||
27 | Male | mRNA-BNT162b2 (Pfizer-BioNTech) | Normal | 320/12.5 | 3 wk after dose 2 | None | T1DM | 0.87 | 725 | Basal insulin | Recovery | ||
36 | Male | mRNA-BNT162b2 (Pfizer-BioNTech) and CoronaVac | Normal | 526/12.6 | 3 wk after dose 2 | None | T1DM | 0.38 | 234 | Insulin infusion | Recovery | ||
Sato et al[61] | 43 | Male | mRNA-based SARS-CoV-2 vaccination | 94/5.6 | 655/8.0 | 14 d after dose 2 | Malignant melanoma | Fulminant T1DM | 0.33 | Insulin infusion | Discharged | mRNA vaccine may trigger T1DM | |
Yakou et al[62] | 71 | Female | mRNA-BNT162b1 (Pfizer-BioNTech) | 93/8.1 | 944/8.0 | 1 d after dose 2 | T1DM | Diabetic ketoacidosis | < 0.03 | > 2000 | Insulin infusion | Discharged | Risk of inducing ketoacidosis after vaccination in T1DM patients |
52 | Female | mRNA-BNT162b1 (Pfizer-BioNTech) | 106 | 494/11.6 | 1 d after dose 2 | T1DM | Diabetic ketoacidosis | ND | 123 | Insulin infusion | Discharged | ||
Mishra et al[63] | 58 | Female | Covishield™ (ChAdOx1-nCOV) (AstraZeneca) | 110 | 183 | 1 d after dose 1 | T2DM | T2DM | NR | NR | Increased dose of metformin. | Discharged | Vaccination may result in a mild and temporary increase in blood glucose levels |
64 | Male | Covishield™ (ChAdOx1-nCOV) (AstraZeneca) | 95 | 150 | 1 d after dose 1 | T2DM | T2DM | NR | NR | Without additional intervention | Discharged | ||
65 | Male | Covishield™ (ChAdOx1-nCOV) (AstraZeneca) | 107 | 186 | 6 d after dose 1 | T2DM | T2DM | NR | NR | Without additional intervention | Discharged | ||
Abu-Rumaileh et al[64] | 58 | Male | mRNA-BNT162b1 (Pfizer-BioNTech) | 80 | 1253/13 | 26 d after dose 1 | Hypertension | T2DM | 1.1 | NR | Insulin infusion | Discharged | COVID-19 vaccine has a risk of causing new-onset T2DM |
Sasaki et al[65] | 73 | Female | Moderna (Spikevax, mRNA-1273) | 7.3 | 318/9.3 | 8 wk after dose 2 | Osteoporosis, mild glucose intolerance | T1DM | 0.48 | > 2000 | Intensive insulin therapy | NR | COVID-19 Vaccination may lead to the new-onset T1DM |
Lee et al[66] | 52 | Female | mRNA-BNT162b2 (Pfizer-BioNTech) | 5.5-6.2 | 1062/12.0 | 3 d after dose 1 | Hypertension | T2DM and nonketotic HHS | NR | NR | Insulin infusion. | Discharged | Vaccination may trigger HHS |
60 | Male | Moderna (mRNA-1273) | 7.5 | 847/13.2 | 2 d after dose 1 | T2DM | T2DM and HHS | NR | NR | Insulin infusion | Discharged | Vaccination may trigger a hyperglycemic episode | |
87 | Male | Moderna (mRNA-1273) | 7 | 923 | 10 d after dose 1 | T2DM | T2DM and HHS and DKA | NR | NR | Insulin infusion | Discharged | Vaccination may trigger HHS and DKA | |
Edwards et al[67] | 59 | Male | Covishield™ (ChAdOx1-nCOV) | 5.6 | 594/14.1 | 21 d after dose 1 | Obesity | Hyperglycemic ketosis | 2352 | NR | NA | Discharged | The first administration of the adenovirus-vectored COVID-19 vaccine can trigger an acute hyperglycemic crisis |
68 | Male | Covishield™ (ChAdOx1-nCOV) | 6.5 | 918/14.7 | 36 d after dose 1 | Pre-diabetes | Mixed HHS/DKA | 5612 | NR | ICU admission | Discharged | ||
53 | Male | Covishield™ (ChAdOx1-nCOV) | 6.2 | 576/17.1 | 20 d after dose 1 | Pre-diabetes | DKA | 3772 | NR | ICU admission | Discharged | ||
Ganakumar et al[68] | 20 | Male | COVISHIELD (ChAdOx1 nCoV-19) | NR | 14.1 | 1 d after dose 2. | None | Severe DKA | NR | NR | Insulin infusion | Discharged | COVID-19 vaccination has the potential to induce DKA |
25 | Female | COVAXIN (BBV152) | NR | 16.3 | 4 d after dose 2 | None | Severe DKA | NR | NR | Insulin infusion | Discharged | ||
Zilbermint et al[69] | 24 | Female | Moderna (mRNA-1273) | NR | 505/12.0 | 15 h after dose 2 | T1DM | Severe DKA | NR | NR | Insulin infusion | NR | A plausible mechanism exists between COVID-19 vaccination and DKA |
Yaturu et al[70] | 56 | Male | BNT162b2 (Pfizer-BioNTech) | 5.6 | 997/14 | Right after the second dose. | Hypertension, primary hyperparathyroidism, and obesity | T2DM and HHS | NR | NR | Insulin infusion | Discharged | COVID-19 vaccination has the potential to induce HHS |
Kshetree et al[71] | 69 | Male | mRNA vaccine | 5.8 | 13.7 | Two months after dose 3 | Hypertension and pre-diabetes | T1DM and DKA | 0.4 | 0.33 | Insulin infusion | Discharged | COVID-19 mRNA vaccine has the potential to induce DKA |
Prasad[72] | 73 | Male | Covishield | 92/7.1 | 215/8 | 6 d after dose 1 | T2DM | T2DM | NR | NR | Insulin infusion | Discharged | Vaccination may cause glycaemic disturbances |
Sasaki et al[73] | 45 | Female | BNT162b2 (Pfizer-BioNTech) | Normal | 344/7.6 | 1 d after dose 1 | None | Fulminant T1DM and DKA | NR | NA | Insulin infusion | Discharged | COVID-19 vaccine might trigger the onset of fulminant T1DM in susceptible individuals |
Yano et al[74] | 51 | Female | Moderna (mRNA-1273) | Normal | 648/10.3 | 28 d after dose 1 | None | Fulminant T1DM and DKA | 1.72 | NA | Insulin infusion | Discharged | COVID-19 vaccination can induce T1DM in some individuals |
Ohuchi et al[75] | 45 | Male | BNT162b2 (Pfizer-BioNTech) | NR | 655 | 3 d after dose 2 | Cutaneous malignant melanoma | Fulminant T1DM | 0.99 | Negative | NR | NR | There is a highly suspicious causal relationship between fulminant T1DM and vaccination, especially in patients treated with ICI |
Ref. | Assessed variables | Findings related to variables | Conclusion | Limitations |
Zhang et al[23] | Hypertension, Comorbidity, Side effects | None | After vaccination, no significant abnormal fluctuations in blood glucose values were observed in the DM patients | Lack of data on the duration of antibodies after vaccination in the study population |
Marfella et al[24] | HbA1c, Time since vaccination, type of vaccine | On Day 21 after the second vaccine dose, T2DM patients with HbA1c > 7% showed significantly reduced virus-neutralizing antibody capacity than normoglycemic subjects and T2DM patients with good glycaemic control. At 21 d after the first vaccine dose, neutralizing antibody titers and CD4 cytokine responses involving type 1 helper T cells were lower in T2DM patients with HbA1c levels > 7% than in individuals with HbA1c levels ≤ 7%. The reduction of HbA1c levels 52 d after vaccination was associated with neutralizing antibody titers and CD4 cytokine increases | Hyperglycemia at the time of vaccination can worsen the immune response, and proper glycemic control can improve the immune response | The statistical significance of the relevant indicators was relatively low |
Kılınç-Toker et al[25] | Age, sex, mixed vaccination, delta variant, BMI, Diabetes, hypertension, COPD, cardiovascular diseases, chronic kidney disease, cancer | Age, male gender, delta variant, and mixed vaccination (CoronaVac plus BioNTech) were associated with death. The delta variant had higher ICU admission and mortality rate | For hospitalized patients who received two doses of the vaccine, diabetes was not associated with their ICU stay and mortality | Retrospective design, short follow-up, and assessment of inpatients only |
Barocci et al[26] | Homologous vaccination, heterologous vaccination, type of vaccine, vaccine schedule, sex, age, BMI, smoking, DM, cardiovascular diseases, respiratory tract diseases, previous SARS-CoV-2 infection, side effects | Heterologous vaccination induced a significantly higher humoral response than homologous vaccination. The type of vaccine influenced antibody titers | DM does not affect antibody levels | Results were influenced by anti-S IgG levels in asymptomatic subjects |
Singh et al[27]1 | Sex, T2DM, age, BMI, side effects, type of vaccine, dose 1, dose 2 | Gender, presence of comorbidities, and vaccine type were independent predictors of antibody seropositivity and anti-spike antibody titer levels. Patients with T2DM had a significantly lower seropositivity rate compared to those without the comorbid disease. Seropositivity rates were lower in those with T2DM compared to those without T2DM. Both vaccine recipients had similar mild to moderate adverse events, and none had serious side effects | T2DM is associated with lower seropositivity rates and anti-spike antibody titers | No assessment of the cell-mediated immune response |
Singh et al[28]1 | Age, previous SARS-CoV-2 infection, sex, BMI, side effects, type of vaccine, dose 1, dose 2, T2DM, blood group, dyslipidemia, ischemic heart disease | The seropositivity rate was significantly higher in the ≤ 60 years age group than in the > 60 years age group at all time points. GMT was significantly higher in participants with past SARS-CoV-2 infection than in SARS-CoV-2-naiveindividuals. | Participants with T2DM had a lower rate of seropositivity at all time points | The sample was drawn from a healthy population with few comorbidities |
Shim et al[29] | Age, DM, type of vaccine, side effects, vaccination interval, hypertension, BMI, sex | There were significant differences in general and neutralizing antibodies based on age, vaccine type, vaccination interval, pain score, diabetes, and hypertension | For all vaccines, subjects with diabetes showed lower rates of neutralizing antibody production after vaccination | Vaccination priority policies bring heterogeneity across age groups |
Alqassieh et al[30] | Age, type of vaccine, hypertension, cardiovascular disease, DM, sex, BMI | Old people (> 60) had lower IgG titers than their younger counterparts. The use of the Pfizer-Biotech vaccine was positively associated with positive IgG titers, while cardiovascular disease had a negative effect on IgG titers. Although diabetes had a negative impact on positive IgG titers, it was not statistically significant | Although DM negatively affected IgG titer positivity, it was not statistically significant | Samples were collected only once at a specific period (6 wk) after vaccination |
Wan et al[31] | Dose 1, dose 2, HbA1c, side effects | None | Patients with T2DM do not appear to have higher risks of AESI and acute diabetic complications after vaccination | Adverse events are defined using diagnosis codes and may be biased by underdiagnosis or misclassification |
Lee et al[32] | Sex, age, DM, type of vaccine, BMI | Being young, female or underweight, and having diabetes were associated with an increased risk of developing grade 3 to 4 adverse reactions after the first dose of the ChAdOx1nCoV-19 vaccine | DM is associated with an increased risk of grade 3 to 4 adverse reactions after the first dose of vaccine, especially in women | Sample from relatively healthy subjects working in hospitals |
Rangsrisaeneepitak et al[33] | T2DM, age, sex, BMI, side effects | After the first dose of AZD1222, the antibody response was weaker in T2DM patients than in non-diabetic patients. The seroconversion rate was higher in the control group than in the diabetic group. Older age was associated with a weaker antibody response in older diabetic patients. The GMC of SARS-CoV-2 IgG antibodies at 56 d was significantly lower in diabetic patients than in age- and sex-matched controls. In the age- and sex-matched controls, SARS-CoV-2 IgG antibody levels were significantly higher in women than in men. During the first 24 h, injection site reactions were more common in diabetic patients than in healthy controls | After the first dose of AZD1222, the antibody response was weaker in T2DM patients than in non-diabetic patients | Participants in the control group were healthcare workers, so natural immunity may have been a confounding factor |
Sourij et al[34] | T2DM, eGFR, HbA1c, side effects, T1D | Age and renal function were significantly associated with the extent of antibody levels. The most common side effect was injection site reactions, with a significantly lower rate in patients with T2DM | The antibody levels after the second vaccination were comparable in healthy controls and in DM patients, irrespective of glycaemic control | Focused only on the humoral immune response after vaccination, but did not investigate the cellular immune response |
Tawinprai et al[35] | DM, hematologic disease, sex, age, time since the first dose of vaccination, BMI, side effects, cardiovascular disease, hypertension, dyslipidemia, end-stage kidney disease | Participants with diabetes or hematologic comorbidities had lower concentrations of anti-RBD antibodies. Anti-RBD antibody concentrations were significantly higher in female participants than in male participants. The immune response was lower in older participants. Anti-RBD antibody concentrations were significantly higher at 2 and 3 mo post-vaccination than at 1-mo post-vaccination | Participants with diabetes or hematologic comorbidities had lower concentrations of anti-RBD antibodies | The presence of participants who did not complete two anti-RBD antibody assays withdrew from the study |
Ali et al[18] | T2DM, age, sex, BMI, comorbidity, previous SARS-CoV-2 infection, hypertension | T2DM is associated with lower titers of neutralizing and IgG antibodies | Both neutralizing antibody and IgG antibody titers were significantly lower in the T2DM group than in the non-diabetic group | Participants in the study were self-selected verbally and through job advertisements |
Karamese et al[36] | T2DM, age, hypertension, COPD, dose 1, dose 2 | Lower antibody response rates were detected in participants with T2DM and in those aged 65 years and older | DM patients have lower antibody levels | The study population was an advanced age group with a high number of comorbidities |
Lustig et al[37] | Age, sex, DM, immunosuppression, hypertension, heart disease, autoimmune disorders, BMI | Lower antibody concentrations are consistently associated with males, older age, immunosuppression, diabetes, hypertension, heart disease, and autoimmune disorders | Lower IgG concentrations and lower detectable IgA antibodies were observed in DM patients, indicating a reduced antibody response to vaccination in these patients | The sample was drawn from a healthy population with few comorbidities |
Islam et al[38] | Hyperglycemia, FPG, age, sex, BMI, hypertension, smoking, alcohol consumption | Spike IgG antibody titers were lower in the presence of hyperglycemia and IFG | Vaccine recipients with diabetes and IFG had lower concentrations of SARS-CoV-2 spike IgG antibodies than the vaccine recipients with normoglycemia did | Associations observed in cross-sectional studies do not necessarily indicate causality |
Parthymou et al[39] | Sex, age, smoking, BMI, DM, hypertension, statin use, vitamin D levels | Age, male gender, and tobacco use are negatively associated with antibody titers after COVID-19 vaccination | Antibody titers were numerically lower in diabetic patients, but this association was not statistically significant | Reliance on questionnaires to record anthropometric parameters and medical history affects reliability |
Priddy et al[40] | Age, DM, sex, BMI, race | IgG and neutralization responses decreased with age. Lower responses were associated with age ≥ 75 and DM | Lower responses were associated with DM | Most of the IgG and neutralization tests used are not standardized |
Naschitz et al[41] | Cancer, DM, congestive heart failure, sex, age, hypertension, COPD, cerebrovascular disease, chronic liver disease, cognitive disability | Cancer, DM, or congestive heart failure were all associated with having a negative serology result | DM is associated with negative serological results | There was a large age difference between the two sample groups |
Güzel et al[42] | Cardiovascular diseases, DM, age, BMI, sex, smoking, vitamin use, viral load, comorbidities | Cardiovascular disease and diabetes were associated with lower IgG antibody levels. In the healthcare workers group, IgG antibody response values were negatively correlated with BMI and age | IgG antibody levels were significantly lower in patients with DM than in those without DM | ELISA test may lead to false positive results |
Virgilio et al[43] | Sex, T2DM, insulin therapy | The negative impact of diabetes in determining a steeper antibody decline was greater in female residents than in male residents. T2DM is associated with a reduced humoral immune response after SARS-CoV-2 vaccination. Antibody kinetics in diabetic patients receiving insulin therapy are similar to those in patients without diabetes | Vaccination in elderly residents with type 2 diabetes is associated with a reduced humoral immune response | Data on blood glucose or glycated hemoglobin levels were not specifically collected to assess the control or severity of diabetes |
Patalon et al[44] | Sex, age, BMI, COPD, DM, congestive heart failure, inflammatory bowel disease | Females were associated with higher levels of antibodies. Lower antibody levels were observed in higher age groups | DM is not a relevant factor affecting antibody levels | The study population was older and had more comorbidities |
Mitsunaga et al[45] | Age, Hypertension, HbA1c, Outdoor exercises, Vaccination interval, BMI, COPD, Dyslipidemia, DM, Autoimmune diseases, Cancer, dose 1, dose 2, BG | Older than 60 years, hypertension, HbA1c higher than 6.5%, and lack of outdoor exercises were significant suppressors of antibody responses, whereas the length of days from the first to the second vaccination longer than 25 d promoted a significant antibody response | HbA1c higher than 6.5% was a significant suppressor of antibody responses | The sample was relatively healthy health workers but did not include participants with serious comorbidities |
Papadokostaki et al[46] | Age, DM, dose 1, dose 2, sample testing time, HbA1c, BMI, duration of diabetes, HbA1c | In the diabetic group, Abs-RBD-IgG was significantly correlated with age and time, and dose after vaccination | The humoral immune responses after the second dose were high and similar in participants with and without DM | No comparison between type 1 and type 2 diabetes |
Zhao et al[47] | DM, dose 1, dose 2, dose 3, age, end-stage kidney disease, cancer, steroid use, previous SARS-CoV-2 infection, time since vaccination | DM was significantly associated with a decrease in response intensity after completion of the primary vaccine series, but responses to the third dose were generally robust. Age and malignancy had a negative effect on the initial strength of the humoral immune response. Being over 65 years, end-stage renal disease, diabetes, and clinical comorbidities of steroid use had a negative effect on the humoral immune response. SARS-CoV-2 infection enhanced the neutralization antibody response to the third dose | DM was significantly associated with a decrease in response intensity after completion of the primary vaccine series, but responses to the third dose were generally robust | Small sample size |
Santotoribio et al[48] | Age, sex, DM, hypertension, heart disease | None | Serum antibody levels were not significantly reduced in patients with common conditions such as arterial hypertension, diabetes, heart disease, or chronic respiratory disease | No assessment of the cell-mediated immune response |
Mehta et al[49] | DM, immunosuppression, vaccination interval, sex, comorbidity | DM, immunosuppression, and vaccination interval were all significantly associated with anti-RBD antibodies | DM patients had significantly lower titers of anti-spiking antibodies than patients without diabetes | The sample group was patients with autoimmune rheumatic diseases with a high proportion of comorbidities |
Ajlan et al[50] | DM, type of vaccine, age, triple immunosuppressive therapy, side effects, sex, time since transplantation | Diabetes and triple immunosuppressive therapy appear to significantly affect the immune response. Triple immunosuppressive therapy and age were identified as significant factors in the lack of response to the vaccine after the second dose. Response rates after the first dose of vaccine with the Pfizer vaccine were higher than those with the AstraZeneca vaccine | Diabetes mellitus and triple immunosuppressive therapy appear to significantly affect response | Lack of immunocompetence control group |
Billany et al[51] | Age, immunosuppression, previous SARS-CoV-2 infection, sex, race, DM | Patients with detectable antibodies were younger than patients without detectable antibodies. Patients who were immunosuppressed were less likely to have detectable antibodies than patients who were not immunosuppressed. Patients previously infected with COVID-19 were more likely to have detectable antibodies than those with no history of SARS-CoV-2 infection | There was no difference in antibody testing with or without DM | Small sample size |
Aberer et al[52] | TIR, TBR, TAR, T1DM, T2DM, carbohydrate intake, CV | None | At the time of side effects, T1DM patients had significantly less TIR and significantly more TAR, while there was no effect on T2DM patients | Short assessment time and small sample size |
Piccini et al[53] | Side effects, dose 1, dose 2, TIR, time in different glucose ranges, mean glucose levels, TDD of insulin, bolus proportion, type of vaccine | Side effects after the vaccination were mild and more frequent after the second dose. No severe adverse reactions were reported | No significant differences in glycemic control and glycemic indices were observed at different times throughout the vaccination cycle and were independent of the vaccine type | Small sample size |
Heald et al[54]1 | Age, BMI, mode of treatment, sex, HbA1c, type of vaccine, duration of diagnosed T1DM | The fall in the percentage BG on target was also greater for those with a median BMI of 28.1 kg/m2 or more. The fall in the percentage BG on target categorized by additional Metformin/Dapagliflozin was greater than no oral hypoglycemic agents, and the median age ≥ 53 yr was greater than < 53 yr | In T1DM, COVID-19 vaccination can cause a temporary BG disturbance, and this effect is more pronounced in patients taking oral hypoglycemic drugs plus insulin and in the elderly | No analysis of changes in insulin dose in the week following the COVID-19 vaccination |
D'Onofrio et al[55] | TIR, TBR, TAR, CV, dose 1, dose 2, insulin dosage, SD | None | Pre- and post-CGM data collected during the two vaccine doses did not show any significant differences between the two groups in terms of TIR, TAR, TBR, CV, and SD | Small sample size |
Heald et al[56]1 | Medication, HbA1c, oral hypoglycemic drugs plus insulin therapy, age, sex, type of vaccine, duration with diabetes, BMI | COVID-19 vaccination can cause a temporary perturbation of interstitial glucose, an effect that is more pronounced in patients taking oral hypoglycemic agents plus insulin. This effect was more pronounced in those with lower HbA1c | In T1DM, vaccination can cause a temporary perturbation of interstitial glucose. There is no difference between the AstraZeneca and the Pfizer vaccines | The effects of the first and second vaccination on interstitial glucose regulation could not be compared |
Gouda et al[57] | TIR, TDD of insulin, dose 1, dose 2, type of vaccine, insulin dosage, average glucose level, bolus insulin, automated bolus | One week after vaccination, there was a slight decrease in TIR along with an increase in mean blood glucose levels, but both were statistically insignificant | No differences in blood glucose or glycemic perturbations were shown before and after vaccination in patients with T1DM. There was no correlation between vaccine side effects and TIR | The effects of the first and second vaccination on interstitial glucose regulation could not be compared |
- Citation: He YF, Ouyang J, Hu XD, Wu N, Jiang ZG, Bian N, Wang J. Correlation between COVID-19 vaccination and diabetes mellitus: A systematic review. World J Diabetes 2023; 14(6): 892-918
- URL: https://www.wjgnet.com/1948-9358/full/v14/i6/892.htm
- DOI: https://dx.doi.org/10.4239/wjd.v14.i6.892