Status:
COMPLETED
DIgital Assisted MONitoring for DiabeteS - I
Lead Sponsor:
University of Bari
Collaborating Sponsors:
Eli Lilly and Company
LifeScan
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The study aims to validate the clinical efficacy of a telemedicine- and web-based system platform for Self-monitoring of blood glucose (SMBG) data transmission and analysis in terms of improved metabo...
Detailed Description
Self-monitoring of blood glucose (SMBG) is currently recommended in all type 1 diabetic patients and type 2 diabetic treated with insulin (≥4 glucose testing per day), as a tool to favor achievement o...
Eligibility Criteria
Inclusion
- males and females
- age 18-70 yrs;
- insulin-treated diabetes (both type 1 and type 2 diabetes treated with at least 3 injections/day);
- diabetes diagnosis from at least 1 year;
- inadequate glycemic control (HbA1c ranging from 7.0% to 10.0%; local measurements within the last 6 weeks);
- ability and willingness to carry out SMBG;
- informed consent.
Exclusion
- diagnosis of diabetes within less than 1 year;
- impending complications of diabetes: proliferative retinopathy or maculopathy (with significant loss of visual function), severe renal failure (eGFR \<30), severe neuropathy (autonomic dysfunction, peripheral neuropathy, gastroparesis);
- clinically significant, active (over the past 12 months) disease of the cardiovascular, gastrointestinal, neurological, genito-urinary, haematological systems or severe uncontrolled hypertension (SBP \>180 mmHg; DBP \>100 mmHg);
- diagnosis of active neoplasia within the last 5 years (history of chemotherapy or radiation treated malignancy within 5 years prior to study procedure, except for lymphoma);
- pregnancy or intention to become pregnant during the study;
- poor compliance to study procedures.
Key Trial Info
Start Date :
September 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2017
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT01804803
Start Date
September 9 2013
End Date
November 30 2017
Last Update
June 4 2020
Active Locations (3)
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1
University of Bari Aldo Moro
Bari, BA, Italy, 70124
2
IRCSS Casa Sollievo Sofferenza
San Giovanni Rotondo, FG, Italy
3
University of Foggia
Foggia, Italy