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

Not Applicable

Completed

• Conditions: Type 1 Diabetes; Nutritional, Metabolic, Endocrine; Diabetes

• Registration Number: ISRCTN66986330
• Lead Sponsor: Roche Diagnostics Corporation (USA)

Brief Summary

2008 results in: https://www.ncbi.nlm.nih.gov/pubmed/18715213 (added 24/05/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2007-01-05
• Study Start: 2007-11-06
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in glucose control by at least 0.4% reduction in HbA1c values in subjects using insulin guidance software at 6 months and 1 year.