An Investigation Into Diurnal Variability in Glucose Levels in Paediatric Patients With Type 1 Diabetes (T1D) and Their Responses to Different Food Compositions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Mean Postprandial Glucose
研究概览
简要总结
The study proposed to recruit approximately 435 children and young people who have T1D and who regularly use Dexcom continuous glucose monitoring (CGM). Recruitment was be via their local dietitian. The dietitian was asked to provide baseline information about the participants which will include demographic data and information on clinical data, treatment and anthropometrics. Participants will be asked to provide access to Dexcom CGM data throughout the period of recording. Participants were issued with, for seven consecutive days, two survey questionnaires, one in the morning at breakfast time and the other in the evening. The morning survey will include questions on the breakfast meal (including a photograph of the meal) and insulin dosage, similarly the evening survey will also include questions on diabetes management and food and fluid intake in addition to questions on activities all of which took place during the four-hour postprandial period. These data will be statistically described using univariate, bivariate and multivariate analysis.
详细描述
This is a quantitative observational study. Dexcom CGM data was collected for the period recording. Retrospective CGM data was collected to assess glucose variability during the day and night time periods. The Participants were then asked to provide information for seven days about their breakfast meal and the four hour post meal period. This included information on the type of meal consumed, a photograph of the meal and their diabetes management for the meal for example the insulin dose amount and timing. For the four hour post meal period the participants were asked about any adjustments they had to make to their diabetes management for example the treatment of high or low glucose readings, any snacks they ate and any activities they took part in. They were also asked to describe their mood during the post meal period.
Recruitment - Paediatric diabetes dietitians, working across the United Kingdom (UK), were enrolled to help recruit participants and become principal investigators (PI) for their site.
As this was an observational study there was no power calculation. The sample size was calculated from the number of dietitians that were likely to be available to help with recruitment; this was estimated to be around 32 and was based on the number that had already been approached. It was felt that they would have capacity to recruit 13-14 participants and this would result in 435 participants.
Methodology Baseline data
In order to make comparisons between relevant variables and glucose levels, the following baseline data will be collected from the dietitians and sent to the chief investigator, along with the artificial identifier on the Excel spreadsheet as discussed earlier at the stage of recruitment of participants:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and young people aged between 1-17 years
- •Diagnosis of type 1 diabetes for a minimum of one year
- •Using multiple daily injections (MDI) together with carbohydrate counting or Continuous Subcutaneous Insulin Infusion (CSII)
- •Using Dexcom continuous glucose monitoring (CGM) on a regular basis.
- •Access to internet and email
排除标准
- •Prescribed anti-hyperglycaemia agents i.e. Glucophage (Metformin) and or antidepressants.
- •Have other medical conditions, including complications of diabetes and coeliac disease will be excluded.
- •Currently enrolled in another research study
结局指标
主要结局
Mean Postprandial Glucose
时间窗: From baseline (start of meal) to 4 hours postprandial at 5min intervals
Mean CGM reading for 387 breakfast meals over 4 hour postprandial period
次要结局
- Diurnal Coefficient of Variation Percentage Over 90 Days(90 days of CGM data)
- Mean Glucose Excursion(From baseline (start of meal) to 4 hours postprandial at 5min intervals)
- Peak Glucose Excursion(From baseline (start of meal) to 4 hours postprandial at 5 min intervals)
- Area Under the Curve(From baseline (start of meal) to 4 hours postprandial at 5 min intervals)
- CV% and Glycaemic Index (GI) of Breakfast Meal(From baseline (start of meal) to 4 hours postprandial)
- Mean Postprandial Glucose and Glycaemic Index of Breakfast Meal(From baseline (start of meal) to 4 hours postprandial)
- Nocturnal Coefficient of Variation Percentage Over 90 Days(90 days of CGM data)
- Time to Peak(From baseline (start of meal) to 4 hours postprandial at 5 min intervals)
- Coefficient of Variation Percentage Over 90 Days(90 days)
- Coefficient of Variation Percentage(From baseline (start of meal) to 4 hours postprandial)
- Time in Range (Minutes)(From baseline (start of meal) to 4 hours postprandial at 5min intervals)
- Mean Postprandial Glucose and Glycaemic Load of Breakfast Meals(From baseline (start of meal) to 4 hours postprandial)
- Time to Peak Across Categories of Glycaemic Load(From baseline (start of meal) to 4 hours postprandial)
- Mean Postprandial Glucose and Type of Breakfast Meal(From baseline (start of meal) to 4 hours postprandial)