NL-OMON51256尚未招募不适用
Digital, blended lifestyle intervention program for remission and improved management of type 2 diabetes - IBIDEM
Ancora Health BV0 个研究点目标入组 410 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
- 尚未招募
- 发起方
- 入组人数
- 410
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
- •Diabetes: Diagnosis of T2DM without end-organ failure
- •Diagnosis of T2DM
- •BMI: 25-45 kg/m²
- •Age: 18 to 75 years
- •Most recent HbA1c value should be greater than 6.0% (>43 mmol/mol) and, if less
- •than 6.5% (<48 mmol/mol), individuals should still be receiving anti-diabetic
- •Display interest and motivation to enroll in a digital, lifestyle intervention
- •for diabetes
- •Tech-savvy - able to fully use a smartphone/ tablet and app
排除标准
- •- Serious co-morbidities, for example, a severe form of chronic obstructive
- •pulmonary disease (Gold III or IV), heart failure (classes 2-4) kidney failure
- •(eGFR / MDRD) <45 units, or other medically determined end-stage organ failure,
- •on active donor list
- •- Myocardial infarction, stroke, angina, or coronary insufficiency within the
- •previous six months
- •- Requirement of a prescribed medical diet
- •- Weight loss of more than five kg or greater than 10% within the past six
- •- Participation in diabetes therapy within the preceding three years;
- •participation in concurrent weight management or interventional research
- •- Untreated thyroid disease,
- •- Excessive alcohol intake (acute or chronic) defined as the average
- •consumption of three or more alcohol-containing beverages daily or consumption
- •of more than 14 alcoholic beverages per week
- •- Incapacitated patients, and thus unable to fully participate in the trial.
- •- Uncontrolled blood pressure (SBP > 170 mmHg and/or DBP > 100 mmHg)
- •- Use of an insulin pump
- •- Type 1 diabetes
- •- Substance abuse
- •- Non-English or Non-Dutch speaking
- •- Cancer requiring treatment in the past five years, with the exception of
- •non-melanoma skin cancer
- •- Chronic infectious disease requiring ongoing treatment
- •- Diabetic retinopathy requiring treatment
- •Pregnancy, consideration of pregnancy within the study period,
- •lactation, or having given birth within the previous nine months
- •- History of keto-acidosis
- •- Current treatment with anti-obesity drugs
- •- Eating disorder or purging behaviour
- •- Currently uncontrolled major psychiatric disorder (e.g., schizophrenia,
- •bipolar disorder) or use of antipsychotic drugs.
- •-- Hospital admission for depression
- •- Learning difficulties limiting the participation in a digital health
- •intervention and or limiting the comprehension of trial goals or coaching
- •curriculum.
- •- Other chronic diseases or conditions likely to limit lifespan to less than
- •- Severe visual impairment or other impairment preventing interaction with
- •digital content
- •- Cholelithiasis or biliary dysfunction
- •- Creatinine > 2.0 mg·dL-1 or > 152.5 µmol·L-1
- •- Urinary albumin > 1 g·dL-1 or > 10 g·L-1
- •- Having undergone bariatric surgery
- •- A recent on-record estimated glomerular filtration rate of less than 30
- •mL/min per 1.732 m²
- •- For nutritional ketosis specifically: impaired hepatic function (Bilirubin >2
- •mg·dL-1 or >34.2 µmol·L-1, Albumin < 3.5 g·dL-1 or <35 g·L-1)
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