Category: Abstracts

BACKGROUND

Observational studies support an association between a low blood 25-hydroxyvitamin D level and the risk of type 2 diabetes. However, whether vitamin D supplementation lowers the risk of diabetes is unknown.

METHODS

We randomly assigned adults who met at least two of three glycemic criteria for prediabetes (fasting plasma glucose level, 100 to 125 mg per deciliter; plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per deciliter; and glycated hemoglobin level, 5.7 to 6.4%) and no diagnostic criteria for diabetes to receive 4000 IU per day of vitamin D₃ or placebo, regardless of the baseline serum 25-hydroxyvitamin D level. The primary outcome in this time-to-event analysis was new-onset diabetes, and the trial design was event-driven, with a target number of diabetes events of 508.

RESULTS

A total of 2423 participants underwent randomization (1211 to the vitamin D group and 1212 to the placebo group). By month 24, the mean serum 25-hydroxyvitamin D level in the vitamin D group was 54.3 ng per milliliter (from 27.7 ng per milliliter at baseline), as compared with 28.8 ng per milliliter in the placebo group (from 28.2 ng per milliliter at baseline). After a median follow-up of 2.5 years, the primary outcome of diabetes occurred in 293 participants in the vitamin D group and 323 in the placebo group (9.39 and 10.66 events per 100 person-years, respectively). The hazard ratio for vitamin D as compared with placebo was 0.88 (95% confidence interval, 0.75 to 1.04; P=0.12). The incidence of adverse events did not differ significantly between the two groups.

CONCLUSIONS

Among persons at high risk for type 2 diabetes not selected for vitamin D insufficiency, vitamin D₃supplementation at a dose of 4000 IU per day did not result in a significantly lower risk of diabetes than placebo. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; D2d ClinicalTrials.gov number, NCT01942694. opens in new tab.)

Source: NEJM

Diabetic ketoacidosis (DKA) is a serious acute complication of type 1 diabetes, which is receiving more attention given the increased DKA risk associated with SGLT inhibitors. Sociodemographic and modifiable risk factors were identified with strong evidence for an increased risk of DKA, including socioeconomic disadvantage, adolescent age (13–25 years), female sex, high HbA _1c, previous DKA, and psychiatric comorbidities (eg, eating disorders and depression). Possible prevention strategies, which include the identification of people at risk based on non-modifiable sociodemographic risk factors, are proposed. As a second risk mitigation strategy, structured diabetes self-management education that addresses modifiable risk factors can be used. Evidence has found that structured education leads to reduced DKA rates. Knowledge of these risk factors and potent risk mitigation strategies are important to identify subgroups of people with an elevated DKA risk. This knowledge should also be used when adjunct therapy options with an increased DKA risk are considered. Prevention of DKA in people with type 1 diabetes is an important clinical task, which should also be addressed when SGLT inhibitors are part of therapy.

Source: The Lancet Diabetes & Endocrinology

Importance  Because rotavirus infection is a hypothesized risk factor for type 1 diabetes, live attenuated rotavirus vaccination could increase or decrease the risk of type 1 diabetes in children.

Objective  To examine whether there is an association between rotavirus vaccination and incidence of type 1 diabetes in children aged 8 months to 11 years.

Design, Setting, and Participants  A retrospective cohort study of 386 937 children born between January 1, 2006, and December 31, 2014, was conducted in 7 US health care organizations of the Vaccine Safety Datalink. Eligible children were followed up until a diagnosis of type 1 diabetes, disenrollment, or December 31, 2017.

Exposures  Rotavirus vaccination for children aged 2 to 8 months. Three exposure groups were created. The first group included children who received all recommended doses of rotavirus vaccine by 8 months of age (fully exposed to rotavirus vaccination). The second group had received some, but not all, recommended rotavirus vaccines (partially exposed to rotavirus vaccination). The third group did not receive any doses of rotavirus vaccines (unexposed to rotavirus vaccination).

Main Outcomes and Measures  Incidence of type 1 diabetes among children aged 8 months to 11 years. Type 1 diabetes was identified by International Classification of Diseases codes: 250.x1, 250.x3, or E10.xx in the outpatient setting. Cox proportional hazards regression models were used to analyze time to type 1 diabetes incidence from 8 months to 11 years. Hazard ratios and 95% CIs were calculated. Models were adjusted for sex, race/ethnicity, birth year, mother’s age, birth weight, gestational age, number of well-child visits, and Vaccine Safety Datalink site.

Results  In a cohort of 386 937 children (51.1% boys and 41.9% non-Hispanic white), 360 169 (93.1%) were fully exposed to rotavirus vaccination, 15 765 (4.1%) were partially exposed to rotavirus vaccination, and 11 003 (2.8%) were unexposed to rotavirus vaccination. Children were followed up a median of 5.4 years (interquartile range, 3.8-7.8 years). The total person-time follow-up in the cohort was 2 253 879 years. There were 464 cases of type 1 diabetes in the cohort, with an incidence rate of 20.6 cases per 100 000 person-years. Compared with children unexposed to rotavirus vaccination, the adjusted hazard ratio was 1.03 (95% CI, 0.62-1.72) for children fully exposed to rotavirus vaccination and 1.50 (95% CI, 0.81-2.77) for children partially exposed to rotavirus vaccination.

Conclusions and Relevance  The findings of this study suggest that rotavirus vaccination does not appear to be associated with type 1 diabetes in children.

Source: JAMA Pediatrics