Status:
UNKNOWN
Insulin Administration Plus a Telemedicine System (Diabetes Interactive Diary - DID) vs Insulin Plus Common Practice
Lead Sponsor:
Consorzio Mario Negri Sud
Collaborating Sponsors:
Sanofi
LifeScan
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 profess...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01192711
Start Date
May 1 2009
Last Update
September 2 2010
Active Locations (13)
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1
Ospedale G.B. Morgagni - L. Pierantoni
Forlì, Italy, 47100
2
P.O. di Grosseto - Stabilimento Misericordia
Grosseto, Italy, 58100
3
Az. Osp. S. Anna - Presidio Ospedaliero Cantù - Mariano Comense
Mariano Comense, Italy, 22066
4
Istituto Scientifico San Raffaele
Milan, Italy, 20132