NL-OMON41020已完成不适用
MaxABC study: effect of Automated Bolus Calculation on glycemic variability and relation with psychological problems. Pilot study. - MaxABC study - Pilot
Maxima Medisch Centrum0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Subject is * 18 years of age.
- •* Patient is diagnosed with Type 1 or Type 2 diabetes, with an HbA1c in the range of 48-86 mmol/mol, with either multiple hypoglycemia episodes (defined as >1 per month) or large daily variability. HbA1c has remained stable within a range of 12 mmol/mol in the year prior to inclusion.
- •* Subject has had diabetes for >12 months.
- •* Subject has been on Multiple Daily Injections (MDI) insulin therapy for at least 6 months
- •* Subject adjusts meal insulin doses based on carbohydrate content of meals.
- •* Subject is sub-optimally controlled at investigator*s discretion.
排除标准
- •* Subject has been diagnosed with any clinically significant condition at investigator*s discretion e.g. infectious disease, major organ system disease, Gastroparesis, Psychosis or cognitive impairment, severe or moderate renal impairment, defined by an eGFR <50ml/m/1.73, active proliferative retinopathy.
- •* Subject is on chemotherapy or radiation therapy (self-reported)
- •* Subject is pregnant, breast feeding or currently planning a pregnancy (self-reported).
- •* Patient is unable to work with a PDA and or smartphone at investigator*s discreation.
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