ISRCTN79006041进行中（未招募）未知
Can a remotely monitored, home-based exercise intervention for individuals with type 1 diabetes reduce immune-driven disease activity?
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39224197/ (added 03/09/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 14/11/2023:
- •1. Aged over 18 years
- •2. Clinical diagnosis of T1D made within the last 3 years
- •3. Confirmed clinical diagnosis of T1D
- •4. Confirmed HLA-A2*0201+ genotype
- •5. Self administering their insulin as part of a multiple dose injection regime or insulin pump therapy.
- •6. Both participant and physician feel that they are able to exercise safely.
- •7. Patient is able to estimate carbohydrate content of meals
- •8. Patient is willing to test glucose and adjust insulin and carbohydrate doses accordingly
- •9. Patients will be able to recognise hypoglycaemic symptoms before capillary blood glucose falls to 3.5mmol/L
- •10. Compliance: understands and is willing, able and likely to comply with all study procedures and restrictions.
- •11. Consent: demonstrates an understanding of the study and willingness to participate, as evidenced by voluntary written informed consent.
- •Previous inclusion criteria:
- •1. Aged over 18 years
- •2. Clinical diagnosis of T1D made within the last 1 year
- •3. Confirmed diagnosis of T1D via T1D-GRS2
- •4. Confirmed HLA-A2*0201+ genotype
- •5. Self administering their insulin as part of a multiple dose injection regime or insulin pump therapy.
- •6. Both participant and physician feel that they are able to exercise safely.
- •7. Patient is able to estimate carbohydrate content of meals
- •8. Patient is willing to test glucose and adjust insulin and carbohydrate doses accordingly
- •9. Patients will be able to recognise hypoglycaemic symptoms before capillary blood glucose falls to 3.5mmol/L
- •10. Compliance: understands and is willing, able and likely to comply with all study procedures and restrictions.
- •11. Consent: demonstrates an understanding of the study and willingness to participate, as evidenced by voluntary written informed consent.
排除标准
- •Current exclusion criteria as of 14/11/2023:
- •1. Uncontrolled blood pressure
- •2. Pregnancy or planning pregnancy
- •3. Currently engaging in more than 150 minutes of exercise per week
- •4. Additional health conditions that might put the participant at risk for this study e.g. cardiac disease, active proliferative diabetic retinopathy, autonomic neuropathy and/or a history of severe hypoglycaemia requiring third party assistance within the last 3 months. Any other condition (medical or psychological) that is deemed inappropriate will be at the PI’s discretion.
- •5. Unable to provide full informed consent.
- •Previous exclusion criteria:
- •1. Uncontrolled blood pressure
- •2. Pregnancy or planning pregnancy
- •3. Adhering to the current recommended physical activity guidelines (> 150 minutes)
- •4. Additional health conditions that might put the participant at risk for this study e.g. cardiac disease, active proliferative diabetic retinopathy, autonomic neuropathy and/or a history of severe hypoglycaemia requiring third party assistance within the last 3 months. Any other condition (medical or psychological) that is deemed inappropriate will be at the PI’s discretion.
- •5. Unable to provide full informed consent.
研究者
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