Mini-Dose Glucagon to Treat Fasting-induced Hypoglycemia During Ramadan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in glucose values from baseline to 30 minute
研究概览
简要总结
This study aimed to develop a new approach for the treatment of fasting induced hypoglycemia during ramadan using mini-dose glucagon.
详细描述
This study aimed to understand whether subcutaneously-given mini-dose glucagon (MDG) as an alternative to carbohydrate consumption could avert hypoglycemia or treat it effectively in type 1 diabetes patients who choose to fast during Ramadan in observance of their faith. This treatment method could also avert any negative psychological emotions Muslim people with diabetes may experience by ingesting carbohydrates to control hypoglycemia, thereby breaking their fast. Furthermore, it could improve ability to self-manage fasting, which is an important action for their spiritual and overall wellbeing.
There will be two phases included in this study:
- Pre-crossover Phase:
Before starting the crossover trial, a pre-crossover phase will conduct to evaluate hypoglycemia eligibility, frequency and compliance. 2. Crossover Trial Phase:
The Crossover Trial Phase will include 20 participants and consist of two (2-weeks) periods. Participants who don't develop any hypoglycemic event or failed to complete both periods will be excluded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of T1DM using daily insulin
- •18.0 to < 65.0 years of age with body mass index 20.0 to <35.0 kg/m
- •Having diabetes for ≥2.0 years
- •HbA1c <8.5%
- •Has a smart phone with access to the internet and welling to upload data during the study period.
- •Welling to wear a devise such as continuous glucose monitor ≥6 days/week.
- •Females, not currently known to be pregnant
- •In good general health as evaluated by investigator based on available clinical data
- •Willing to comply to the protocol requirements for the duration of the study
排除标准
- •Any history of more than one severe hypoglycemic episode (need assistance by third party) in the past 12 months
- •Any history of more than one episode of diabetic ketoacidosis in the past 12 months
- •Female pregnant or planning to get pregnant.
- •Use of any of the following medications: oral hypoglycemic agents, systemic corticosteroids or beta-blocker, theophylline, beta-adrenergic agonists, 1st generation anticholinergic drugs.
- •History of hypersensitivity to glucagon or severe hypersensitivity reactions (such as angioedema) to any other medications
- •History of uncontrolled hypertension (systolic BP >160 mmHg or diastolic BP >100 mmHg)
- •History of seizure disorder.
- •Presence of any of conditions based on judgment of the investigator that could affect or interfere with the response, absorption, metabolism or execration of glucagon.
- •Currently following any kind of weight-loss diet
- •Currently participation in another clinical trials
研究组 & 干预措施
Glucagon injection
Dilute Glucagon (1 mg/ml)
干预措施: Glucagon Injection (Drug)
Glucose tablets
Dextrose glucose tablets
干预措施: Glucose Tablets (Other)
结局指标
主要结局
Changes in glucose values from baseline to 30 minute
时间窗: 30 minutes
The change in blood glucose from baseline to 30 minute following treatment of hypoglycemic events
次要结局
- Events approached 100 mg/dL or increased by 30 mg/dL(60 Minutes)
- Minimum Glucose, during hypoglycemia event by CGM(120 Minutes)
- Treatment success from first dose(60 Minutes)
- Mean Glucose Value, during hypoglycemia event by CGM(120 Minutes)
- Time in Range, during hypoglycemia event by CGM(120 Minutes)
- Time spend below 70 mg/dL, during hypoglycemia event by CGM(120 Minutes)
- Maximum Glucose, during hypoglycemia event by CGM(120 Minutes)
- The proportion of completion of fasts(2 Weeks)
- Mean Glucose Value, by CGM(2 Weeks)
- Time in Range, by CGM(2 Weeks)
- Time spend below 70 mg/dL, by CGM(2 Weeks)
- Time spend above 180 mg/dL, by CGM(2 Weeks)
- Time spend above 250 mg/dL, by CGM(2 Weeks)
- Coefficient of Variation, by CGM(2 Weeks)
研究者
Metab Algeffari
Associate Professor, Diabetologist Consultant
Qassim University