Registry of Individuals with Type 1 Diabetes Living in Canada: the BETTER Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6,000
- 试验地点
- 7
- 主要终点
- Number of non-severe hypoglycemic episodes
研究概览
简要总结
A registry of individuals with type 1 diabetes open to all patients with type 1 diabetes living in Canada will be established. The objective of this registry will be to measure the frequency and the severity of episodes of hypoglycemia. Participants will be invited to answer questionnaires about the frequency of their hypoglycemic episodes, their fear about hypoglycemia, their symptoms of hypoglycemia, the factors in cause (insulin therapy, nutrition, exercise, etc.), etc.
Participation to the registry is divided in 3 phases. The first phase is mandatory for all participants. Phases 2 and 3 are optional.
详细描述
The objective of phase 1 is to draw an overall picture of the population with type 1 diabetes in Canada in terms of demographics, diabetes treatment, hypoglycemia frequency and diabetes complications. It takes about 10 minutes to answer the questionnaire. If the participant uses a continuous glucose monitor and agrees, the participant is invited to send the latest report of the continuous glucose monitor.
The objective of phase 2 is to characterize the causes, experience and consequences of hypoglycemia. Phase 2 also involves, if the participant accepts and live in the province of Quebec or Alberta, to provide the research team with their latest blood and urine tests as well as their list of medications.
The objective of phase 3 is to collect information on diabetes and hypoglycemia treatment, hyperglycemia management, sleep habits, depression, physical activity and the benefits of technologies to reduce the frequency of hypoglycemia. Phase 3 also involves, if the participant agrees, answering a food questionnaire, wearing a step counter, measuring waist circumference
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 diabetes
- •Living in Canada
排除标准
- •Type 2 diabetes
- •Gestational diabetes
结局指标
主要结局
Number of non-severe hypoglycemic episodes
时间窗: 12 months
Participants will be asked to report the number of non-severe hypoglycemic episodes in the last 12 months in a questionnaire designed by the investigators. The definition of non-severe hypoglycemia is a blood sugar below 3.0 mmol/L that the participant was able to treat himself
次要结局
- Number of steps(14 days)
- Number of severe hypoglycemic episodes(12 months)
- Diabetes distress(1 month)
- Physical activity(1 week)
- Fear of hypoglycemia(6 months)
- Sleep habits(1 month)
- Depression(2 weeks)
- Medical follow-up for diabetes(12 months)
- Insulin doses(3 days)
研究者
Rémi Rabasa-Lhoret
Full professor
Institut de Recherches Cliniques de Montreal