ABSTRACT
OBJECTIVES: Recombinant zoster vaccine (RZV) is Food and Drug Administration approved for the prevention of herpes zoster (shingles) in adults 50 years old and older. Immunocompromised subjects were excluded from the pivotal vaccine trials. We studied the safety of this vaccine in our university-affiliated rheumatology practice. METHODS: This was a single-center, retrospective study focusing on subjects who received RZV during 2018. We collected the demographic data, any self-reported adverse events after vaccination, C-reactive protein, Routine Assessment of Patient Index Data 3 (RAPID3) scores for subjects with rheumatoid arthritis, and available RAPID3 scores for all study subjects before and after the vaccination. RESULTS: Comparision of C-reactive protein (n = 40), RAPID3 scores for subjects with rheumatoid arthritis (n = 16), and available RAPID3 scores for all subjects (n = 21) using the paired t test, did not show significant differences before and after the administration of RZV. A total of 6.4% of patients reported adverse events after vaccination. The adverse events were mild and did not lead to hospitalization, end organ damage, or change in treatment plan. CONCLUSIONS: The RZV was safe and well tolerated among our study population.
Subject(s)
Arthritis, Rheumatoid/complications , Herpes Zoster/drug therapy , Patient Safety/standards , Vaccines, Synthetic/adverse effects , Adult , Aged , Arthritis, Rheumatoid/physiopathology , Herpes Zoster/prevention & control , Humans , Male , Middle Aged , Patient Safety/statistics & numerical data , Retrospective Studies , Rheumatology/methods , Rheumatology/statistics & numerical data , Vaccines, Synthetic/therapeutic useABSTRACT
BACKGROUND: The Food Insulin Index (FII) is a novel algorithm for ranking foods based on their insulin demand relative to an isoenergetic reference food. We compared the effect of carbohydrate counting (CC) versus the FII algorithm for estimating insulin dosage on glycemic control in type 1 diabetes. MATERIALS AND METHODS: In a randomized, controlled trial, adults (n = 26) using insulin pump therapy were assigned to using either traditional CC or the novel Food Insulin Demand (FID) counting for 12 weeks. Subjects participated in group education and individual sessions. At baseline and on completion of the trial, glycated hemoglobin A1c (HbA1c), day-long glycemia (6-day continuous glucose monitoring), fasting lipids, and C-reactive protein were determined. RESULTS: Changes in HbA1c from baseline to 12 weeks were small and not significant in both groups (mean ± SEM; FII vs. CC, -0.1 ± 0.1% vs. -0.3 ± 0.2%; P = 0.855). The incremental area under the curve following breakfast declined significantly among the FID counters with no change in the CC group (FID vs. CC, -93 ± 41 mmol/L/min [P = 0.043] vs. 4 ± 50 mmol/L/min [P = 0.938]; between groups, P = 0.143). The mean amplitude of the glycemic excursion (MAGE) was significantly reduced among the FID counters (FID vs. CC, -6.1 ± 1.0 vs. -1.3 ± 1.0 mmol/L; P = 0.003), and only the FID counters experienced a trend (-44% vs. +11%; P = 0.057) to reduced hypoglycemia. CONCLUSIONS: In a 12-week pilot study, MAGE and postprandial glycemia following breakfast were significantly improved with FII counting versus CC, despite no significant differences in HbA1c.
Subject(s)
Diabetes Mellitus, Type 1/diet therapy , Diet, Diabetic/methods , Food/classification , Hyperglycemia/prevention & control , Hypoglycemia/prevention & control , Hypoglycemic Agents/administration & dosage , Insulin/administration & dosage , Adult , Aged , Algorithms , Combined Modality Therapy/adverse effects , Diabetes Mellitus, Type 1/drug therapy , Feasibility Studies , Female , Glycated Hemoglobin/analysis , Humans , Hypoglycemia/chemically induced , Hypoglycemic Agents/adverse effects , Hypoglycemic Agents/therapeutic use , Insulin/adverse effects , Insulin/therapeutic use , Insulin Infusion Systems , Male , Meals , Middle Aged , Patient Education as Topic , Pilot Projects , Young AdultABSTRACT
OBJECTIVE: Although carbohydrate counting is routine practice in type 1 diabetes, hyperglycemic episodes are common. A food insulin index (FII) has been developed and validated for predicting the normal insulin demand generated by mixed meals in healthy adults. We sought to compare a novel algorithm on the basis of the FII for estimating mealtime insulin dose with carbohydrate counting in adults with type 1 diabetes. RESEARCH DESIGN AND METHODS: A total of 28 patients using insulin pump therapy consumed two different breakfast meals of equal energy, glycemic index, fiber, and calculated insulin demand (both FII = 60) but approximately twofold difference in carbohydrate content, in random order on three consecutive mornings. On one occasion, a carbohydrate-counting algorithm was applied to meal A (75 g carbohydrate) for determining bolus insulin dose. On the other two occasions, carbohydrate counting (about half the insulin dose as meal A) and the FII algorithm (same dose as meal A) were applied to meal B (41 g carbohydrate). A real-time continuous glucose monitor was used to assess 3-h postprandial glycemia. RESULTS: Compared with carbohydrate counting, the FII algorithm significantly decreased glucose incremental area under the curve over 3 h (-52%, P = 0.013) and peak glucose excursion (-41%, P = 0.01) and improved the percentage of time within the normal blood glucose range (4-10 mmol/L) (31%, P = 0.001). There was no significant difference in the occurrence of hypoglycemia. CONCLUSIONS: An insulin algorithm based on physiological insulin demand evoked by foods in healthy subjects may be a useful tool for estimating mealtime insulin dose in patients with type 1 diabetes.
