Status:
COMPLETED
Carbohydrate Counting in Adults With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Diabetes Mellitus, Type 1
Insulin Pump, Programmable
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The investigators postulate that carbohydrate (CHO) counting in adult patients with type 1 diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII) may improve glycemic co...
Detailed Description
This study was designed as a randomized, controlled (versus standard education), open, one-center trial. Patients in group 1 were taught carbohydrate counting to estimate insulin preprandial bolus, wh...
Eligibility Criteria
Inclusion
- type 1 diabetes mellitus
- age 18-65
- continuous subcutaneous insulin infusion for at least 3 months
Exclusion
- patients who have already been trained in carbohydrate counting
- known hypothyroidism not on replacement therapy
- renal disease (serum creatinine \>1.4 mg/dl in females and \>1.7 mg/dl in males)
- patients with celiac disease
- pregnancy
- serious diseases or disabilities which may interfere with study assessments
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01173991
Start Date
October 1 2008
End Date
January 1 2010
Last Update
August 3 2010
Active Locations (1)
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1
San Raffaele Scientific Institute
Milan, Italy, 20132