Ultrasound Classification and Grading of Lipohypertrophy and Its Impact on Glucose Variability in Type 1 Diabetes: The TITANIC Studies.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Changes in Glucose variability between baseline and follow-up
研究概览
简要总结
This study will use ultrasound to characterise lipohypertrophy(LH) and assess the impact of LH on glucose variability in adults with type 1 diabetes. LH is a condition that occurs with repeated exposure to insulin at injection sites, resulting in the development of subcutaneous fatty lumps that impede the absorption of insulin. LH can lead to glucose variability, increased risk of severe hypoglycaemia and diabetes distress. In the long term it can therefore lead to increased risk of diabetes complications and increased insulin costs.
详细描述
This is an observational study using ultrasound (US) to assess and characterise lipohypertrophy (LH) with a sub-study to assess the impact of LH on glucose variability in a case-crossover study.
The study aim is to assess LH using ultrasound and its impact on glucose variability.
The objectives of the study are:
- To use ultrasound to characterise (appearance, location, mass, and distribution) LH tissue in participants with T1DM injecting insulin.
- To develop a standard operating procedure for using US to assess LH.
- To develop a grading system to evaluate LH using US.
- To investigate the relationship between the observed LH and glucose variability, glycaemic control, and/or severe hypoglycaemia.
- To assess quality of life, diabetes distress, and insulin treatment satisfaction after moving to a new injection site and being alerted to the existence of LH.
- To learn more about how people living with type 1 manage their injection sites.
Study design:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with Type 1 Diabetes Mellitus (T1DM)
- •Age> 20 years
- •Taking multiple daily injections ≥4 per/day
- •Diagnosed T1DM and using insulin for >3 years
- •Using the same insulin type and delivery method for past 6 months
- •Ability to speak and read English
- •Case-crossover study:
- •Glucose variability with a Standard deviation ≥4mmol/l of mean glucose in the previous four weeks
- •≥4 blood glucose tests per/day
排除标准
- •Age <20 years
- •Type 2 diabetes or Gestational diabetes mellitus (GDM)
- •Have a condition or receiving therapies, other than insulin, associated with lipodystrophies
- •Have another medical condition or take medicines that may influence blood glucose control (including: currently active cancer; uncontrolled endocrine disorder; eating disorders; celiac disease; and cystic fibrosis)
- •Have a serious medical or mental health condition that impairs full engagement in the research
- •Using other injectable treatments in diabetes such as growth hormone or glucagon like peptide-
- •Using Continuous Subcutaneous Insulin Infusion (CSII)
- •Not undertaking blood glucose tests ≥4 tests per day
- •Unable to speak English or unable to give consent
结局指标
主要结局
Changes in Glucose variability between baseline and follow-up
时间窗: 6 weeks
Glucose variability will be measured using the standard deviation of the mean glucose measured at visit 1 and the last visit. For the case-crossover study the data will be taken from the CGM recording and the other participants with their own self-monitoring of glucose measurements.
Changes in Glycaemic control between baseline and follow-up
时间窗: 6 Weeks
Glycaemic control will be assessed in all participants using glycated haemoglobin at first clinical outpatient appointment and at six weeks. In addition, participants at the case-crossover study will have a 1, 5 anhydroglucitol taken at study visit 1 and at six weeks.
次要结局
未报告次要终点