Glycaemic control and prevention of hypoglycaemia in intensively treated subjects with type 1 diabetes using Accu-Chek® advisor insulin guidance software

Roche Diagnostics Corporation (USA)0 个研究点目标入组 123 人开始时间: 2007年11月6日最近更新: 2019年6月17日

适应症

试验速览

•1. Adult - male or female, 18 to 60 years of age
•2. Diagnosed with Type 1 diabetes mellitus at least six months
•3. HbA1c greater than 7.5% and less than 11.0% at screening
•4. Insulin dose 0.5 - 2.0 units/kg
•5. Hematocrit between 25% and 65%
•6. Weight 100 - 300 pounds
•7. On a dual insulin therapy supported by Accu-Chek® insulin advisor software
•8. On a day shift schedule (typical day begins before noon)
•9. Willing to perform a minimum of three blood glucose tests per day - before breakfast, before lunch, and before dinner (standard of care)
•10. Willing to complete at least 7 clinic visits in 12 months (baseline, 2-week, 6-week, 3-month, 6-month, 9-month, and 12-month)
•11. Willing to complete three study phone calls conducted by study coordinator (4.5-month, 7.5-month and 10.5-month)
•12. Able and willing to provide written informed consent to participate
•13. Willing to comply with the study protocol
•14. Willing to be randomised into either the control group or the experimental group

•1. On insulin pump therapy
•2. On oral, inhaled or pre-mixed insulin
•3. Engaged in a minimum of 30 minutes of cardiovascular (aerobic) exercise 5 days out of a 7-day week
•4. Conditions that can cause significant increase of the insulin sensitivity factor, such as a steroid therapy, diabetic ketosis, insulin-resistant syndrome
•5. Creatinine greater than 2.5 mg/dl, renal transplantation or currently undergoing kidney dialysis
•6. Pregnant or intends to become pregnant during the course of the study
•7. Undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer
•8. Plan to travel to a different time zone more than three times per month
•9. Clinical signs or symptoms of liver disease such as jaundice
•10. Diagnosis of acute or chronic hepatitis
•11. Diagnosis of haemoglobinopathy or chronic anaemia
•12. Severe unexplained hypoglycaemia in the past 3 months that required Emergency Department (ED) admission
•13. Participation in another clinical trial in the past 1 month
•14. Weight under 100 pounds or over 300 pounds

发起方

Roche Diagnostics Corporation (USA)