Demystifying the Pizza Bolus: the Effect of Dough Fermentation Time on Glycemic Response in Children With Type 1 Diabetes Mellitus Receiving Sensor-augmented Pump Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Continuous glucose sensor data
研究概览
简要总结
Glycemia following pizza consumption is typically managed with a dual wave insulin bolus. This study evaluated the effect of a simple bolus on glycemia following consumption of traditionally prepared pizzas with long (22 hours) or short (8 hours) dough fermentation periods.
详细描述
All participants received pizza prepared in one of two ways, as described below, on two separate days. On the first day, they were given a pizza prepared with dough fermented for 8 hours (pizza A), and on the second study day they received a pizza prepared with dough fermented for 24 hours (pizza B). Participants and their parents were blinded to the type of pizza served on each day. Both meals were served at 7.00 pm at the pizzeria where the pizza had been prepared, and consumed within 30 minutes.
Children and adolescents aged between 4 and 18 years with type 1 diabetes were eligible for inclusion in the study if they had received SIP therapy (MiniMed™ 640G, Medtronic, Tolochenaz, Switzerland) for at least 3 months One pizza of each type was prepared for chemical analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetes if they had received sensor integrated pump (SIP) therapy for at least 3 months
排除标准
- •Patients with HbA1c >8.5% (69 mmol/mol), celiac disease, other food allergies or concurrent illness
研究组 & 干预措施
Short fermented pizza
the patients ate a pizza that fermented for 8 hours
干预措施: the patients ate a pizza that fermented for 8 hours (Other)
Long fermented pizza
the patients ate a pizza that fermented for 24 hours
干预措施: the patients ate a pizza that fermented for 24 hours (Other)
结局指标
主要结局
Continuous glucose sensor data
时间窗: 11 hours
mmol/L
次要结局
- Content of carbohydrates(1 hour)
研究者
Angela Zanfardino
Principal Investigator
University of Campania "Luigi Vanvitelli"