Flash CONtinous Glucose Monitoring in TRansition to Outpatient: Libre for Type 2 Diabetes Mellitus (CONTROL-DM)
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
This is a pilot study of the use of flash glucose monitoring (FGM) to assess glycemic control, behavioural, quality of life benefits and manpower utilization in poorly controlled T2DM patients on insulin in the transitional care period after discharge from hospital.
详细描述
Background:
Hospitalization often provides an opportunity to optimise the care of patients with diabetes, however, there could be destabilisation of dietary habits and diabetes therapy during admission. During transition from hospital to home, diabetes treatment may be intensified to control hyperglycemia, such as starting insulin therapy, or, de-escalated, due to risks of hypoglycaemia secondary to variable oral intake and physical activity levels peri-hospitalization.
Achieving optimal glycemic control necessitates frequent blood glucose monitoring. However, patients may perceive repeated self-monitoring of blood glucose (SMBG) as inconvenient, intrusive and laborious as it requires pricking their fingers multiple times, resulting in reduced compliance and poorer glycemic outcomes. Ambulatory flash glucose monitoring (FGM) may overcome this and facilitate more rapid achievement of euglycemia due to the benefit of immediate feedback of glucose levels with changes in diet, medication and activity.
As the transitional care period is a period of stress for patients and an opportunity to encourage behavioural change, we propose that the use of intermittent short term FGM in the first two weeks post discharge, and for another two weeks at a 6-week interval may promote behavioural change resulting in improvements in glycemic control.
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 21-80 inclusive
- •HbA1c>9% on insulin
- •Requiring inpatient adjustment of DM medication if meets any of the following:
- •A) Hypoglycemia (defined as glucose < 4 mmol/l occurring 2 or more times at least 3 hours apart in the last 72 hours or any glucose <2.5 mmol/l in the last 24 hours)
- •B) Hyperglycemia (defined as glucose > 14 mmol/l occurring 2 or more times in the last 36 hours, or any glucose > 24 mmol/l in the last 24 hours)
- •Desire to lower HbA1c to a target of 7%
- •Willing to wear FGM device
- •Willing and able to use FreeStyle Librelink app on personal device
- •Willing to avoid use of ascorbic acid throughout the study
- •Willing to perform SMBG (by history) of an average of at least 4 times a day, 3 days a week
排除标准
- •Pregnant or planning pregnancy during duration of study
- •Unable to use or unwilling to comply with study requirements
- •Use of personal FGM within 3 months of screening or plan to use personal FGM during the course of the study
- •On ascorbic acid
- •Extensive skin changes that preclude wearing the sensor on normal skin (e.g. extensive psoriasis, extensive eczema, recent burns or severe sunburn, extensive tattoos, dermatitis herpetiformis)
- •Known allergy to medical-grade adhesives
- •Renal insufficiency (eGFR<30)
- •Pancreatic insufficiency or history of pancreatitis
- •Patients on any structured weight reduction interventions such as prescription weight loss medications, bariatric surgery, or protein sparing modified fast during the course of the study.
- •Current or anticipated short term uses of glucocorticoids (oral, injectable, or intravenous. Long-term stable glucocorticoid doses are allowed, such as for treatment of rheumatoid arthritis or Addison's disease.
- •Any medical condition that would make it inappropriate to target an HbA1c of <7%
- •Currently abusing illicit drugs, alcohol or prescription drugs
- •Any condition per investigator assessment, that could impact reliability of the HbA1c measurement, such as but not limited to hemoglobinopathy, haemolytic anaemia, chronic liver disease, chronic GI blood loss, recent red blood cell transfusion or erythropoietin administration within 3 months prior to screening
- •Current participation in another investigational study (must have completed any prior studies at least 30 days prior to being enrolled in this study)
结局指标
主要结局
HbA1c
时间窗: 6 weeks, 12 weeks
Assess change in glycaemic control between groups
次要结局
- Severe hypoglycemia events(12 weeks)
- Resource utilization(12 weeks)
- Diabetes Distress Scale (DDS)(12 weeks)
- Number of re-admissions for dysglycemia or device-related complications(12 weeks)
- Glycaemic variability(12 weeks)
- Audit of Diabetes-Dependent Quality-of-Life Questionnaire (ADDQoL)(12 weeks)
- Glucose Monitoring Satisfaction Score (GMSS)(12 weeks)
- % Time in range, % Time below range, % Time above range(12 weeks)