Investigation of Glycemic Control Among an International Community of People With Type 1 Diabetes Following a Low Carbohydrate Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Hemoglobin A1C
研究概览
简要总结
The investigators have identified a support group on social media with ~1500 members (children and adults), the majority of whom have T1DM and follow a carbohydrate-restricted diet. Many participants report exceptionally low HbA1C and insulin requirements. If these anecdotal reports are reflective of a large group of people with type 1 diabetes, a clinical trial would be warranted.
The investigators propose to survey the above-mentioned group and their professional diabetes care providers to characterize glycemic control and explore associated dietary and diabetes care factors.
详细描述
The surveys will address questions in the following domains: 1) Diabetes diagnosis and treatment; 2) Carbohydrate-restricted diet; 3) Insulin regimen; 4) Other diabetes related care; 5) Diabetes complications; 6) Other related health and healthcare; 7) Patient provider interactions; 8) Socio-demographics. Drafts of these surveys are included in the appendix of this protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with a diagnosis of T1DM who are currently on insulin treatment or
- •Adults who are a parent or guardian of a child with T1DM who is currently on insulin treatment and
- •Self-reported use of a regimen including carbohydrate restriction for at least 3 months
排除标准
- •Women who are pregnant or breastfeeding.
结局指标
主要结局
Hemoglobin A1C
时间窗: within 3 month of taking the survey
self reported, confirmed by professional diabetes care provider if possible
次要结局
- BMI(within 3 month of taking the survey)
- total daily dietary carbohydrate(within 3 month of taking the survey)
- diabetes-related complication rates - diabetic ketoacidosis, hypoglycemia(timeframe since staring low carb diet (at least three months))
- change in HbA1C(current (within three months of taking the survey) - baseline (last available pre-carbohydrate-restricted diet))
- total daily insulin dose(within 3 month of taking the survey)
- patient-physician relationship(within 3 month of taking the survey)
研究者
Belinda Lennerz
Instructor in Pediatric Endocrinology
Boston Children's Hospital