An Open Label, Multicentre, Randomized Study of Insulin Glargine + Prandial Insulin Glulisine Associated With a Telemedicine System for Carbohydrates Counting vs. Insulin Glargine + Prandial Insulin Glulisine Associated With Common Practice
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 130
- 试验地点
- 13
- 主要终点
- Blood levels of glycosylated hemoglobin
研究概览
简要总结
The Diabetes Interactive Diary (DID) is both a CHO (carbohydrates )/insulin bolus calculator, an information technology and a telemedicine system based on the communication between health care professional and patient by SMS messages.
Aim of the study is to compare an insulin regimen of insulin glargine + prandial insulin glulisine associated with a telemedicine system to teach CHO counting (DID) with the same insulin regimen administered according to usual practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with type 1 diabetes as defined by the criteria of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (29)
- •Males and females
- •Age equal or more than 18 years
- •Patients not habitually using CHO (carbohydrates) counting
- •Self monitoring blood glucose (SMBG) at least 3 times a day
- •Four basal-bolus daily injections of short-acting and long-acting insulin analogues
- •HbA1c equal or more than 7.5%
- •Female patients have to be postmenopausal, hysterectomised or surgically sterilized or using reliable and adequate contraceptive methods (oral contraception or IUD);
- •A full study-specific informed consent must be obtained in writing for all subjects
排除标准
- •Multiple daily injections of NPH insulin or soluble rapid insulin or Continuous Subcutaneous Insulin Infusion (CSII) therapy
- •Mental conditions, depression, or high anxiety rendering the subject unable to understand the nature, scope, and possible consequences of the study
- •Eating disorders
- •Pregnancy / lactation.
- •Any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological or other major systemic diseases or infective diseases making implementation of the protocol or interpretation of the study results difficult
- •Any disease or condition including abuse of illicit drugs, prescription medicines or alcohol that in the opinion of the investigator may interfere with the completion of the study
- •Subjects unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study procedures.
研究组 & 干预措施
insulin + DID
Three prandial (before or at the end of meal administration, based on doctor counselling and patient decision) injections per day of insulin glulisine associated with basal insulin glargine; the DID will be used to estimate the CHO content of the food intended to eat. Insulin doses in this group will be adjusted based on DID calculations and pre-meal BG values.
干预措施: Diabetes Interactive Diary (DID) (Device)
insulin + usual care
Three prandial (before or at the end of meal administration, based on doctor counselling and patient decision) injections of insulin glulisine associated with basal insulin glargine. Insulin doses in group B will be adjusted based on SMBG values reviewed during the doctor office visit.
结局指标
主要结局
Blood levels of glycosylated hemoglobin
时间窗: from baseline every three months until the end of the study
次要结局
- Frequency of patients with hypoglycemic episodes and frequency of hypoglycemic episodes overall(every three months until the end of the study)
- Frequency and times of hypoglycemic events with regard to occurrence during the day (24 hours) and total treatment duration (24 weeks)(every three months until the end of the study)
- blood glucose (BG) levels(from baseline every three months until the end of the study)
- Quality of life(at baseline and at the end of the study)
- Glucose variability(from baseline every three months until the end of the study)
- Change in body weight and BMI(from baseline every three months until the end of the study)
- Total daily insulin dose, total basal insulin dose, total prandial insulin dose(from baseline every three months until the end of the study)
- Frequency of patients with severe and/or symptomatic hypoglycemia and frequency of severe and/or symptomatic hypoglycemic episodes overall(every three months until the end of the study)