The Feasibility of Personalized Hypoglycemia Outpatient Treatment for People Living With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To determine feasibility to recruit an average of 8 patients per month at the study site (The Ottawa Hospital Diabetes clinics) for study protocol performance.
研究概览
简要总结
This study will offer two study interventions designed to bring on a mild low blood sugar (capillary blood glucose result 3.0 to 3.8 mmol/L), in order to study the effectiveness of each study participant's personal choice of treatment and first recheck time.
The two study interventions that the participant can choose to complete (one or both interventions).
Based on each participant's own experience with hypoglycemia treatment or their preferences, the participant can choose one of 4 simple carbohydrate treatment quantities, and choose one of 4 capillary blood glucose recheck times.
详细描述
The two study interventions that the participant can choose to complete (one or both interventions):
Study intervention A: Ride a recumbent exercise bike at participant's own desired speed, until onset of capillary blood glucose showing mild low blood glucose (hypoglycemia).
Study intervention B: Delay food intake after the participant brings and takes their routine clinical care prescribed medication(s) that decrease the blood glucose level. The participant brings in their medication(s) including sulfonylurea or insulin(s) as applicable to the study visit. In front of the study nurse, the participant takes these medication(s) at the same dose or reduced dose as defined in the study protocol. The participant is monitored until capillary blood glucose reaches the mild low blood glucose (hypoglycemia) level of 3.0 to 3.8 mmol/L.
Based on each participant's own experience with hypoglycemia treatment or their preferences, the participant can choose one of 4 simple carbohydrate treatment quantities: 8 grams, 16 grams, 20 grams, 32 grams
The participant can choose one of 4 capillary blood glucose recheck times: 15 minutes, 20 minutes, 25 minutes, 30 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Consent provided
- •Age >= 18 years.
- •Diagnosed as type 2 diabetes mellitus.
- •Type 2 diabetes medications include at least one of the following for at least one month prior to entering the study: sulfonylurea or insulin of any type.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Diagnosed as another form of diabetes mellitus.
- •Has a history of hypoglycemia unawareness.
- •Had a hypoglycemia event, defined as capillary blood glucose < 3.9 mmol/L within 24 hours prior to the study visit booking time.
研究组 & 干预措施
Recumbent Exercise Bike to induce mild hypoglycemia
The participant rides the recumbent exercise bike at their preferred speed and records the distance travelled until there is onset of mild hypoglycemia.
干预措施: Recumbent Exercise Bike to induce mild hypoglycemia (Behavioral)
Delaying food to induce mild hypoglycemia
At the study visit, in front of the study nurse, the participant takes their usual clinical care dose of sulfonylurea or basal insulin. If the participant's usual clinical care includes insulin with a rapid-acting component, then its dose is reduced based on the study protocol.
干预措施: Delaying food to induce mild hypoglycemia, (Behavioral)
结局指标
主要结局
To determine feasibility to recruit an average of 8 patients per month at the study site (The Ottawa Hospital Diabetes clinics) for study protocol performance.
时间窗: 12 months
Average number of patients recruited per month is determined by 60 patients (the target recruitment number) for each study intervention, divided by the number of months that it took to complete the recruitment.
次要结局
- To assess the percentage hypoglycemia resolution for people living with type 2 diabetes based on their personalized choice of treatment and first recheck time.(12 months)