Status:
COMPLETED
Efficacy of Continuous Subcutaneous Insulin Infusion Versus Basal-bolus Multiple Daily Injections Regimen in Type 2 Diabetes
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A lot of insulin-treated type 2 diabetic patients do not reach adequate glycemic control despite intensive basal-bolus insulin regimen. In such cases, continuous subcutaneous insulin infusion (CSII), ...
Detailed Description
Visit 1: patient information and eligibility criteria assessment Visit 2: Inform consent signature and randomisation (group CSII or MDI). Patients randomised in the CSII group are instructed to use pu...
Eligibility Criteria
Inclusion
- Type 2 diabetes mellitus
- Age \> 18 years
- Patients treated for at least 6 months by Multiple daily insulin injections associating long acting insulin (at least 1 long acting insulin analog injection -Glargine or Detemir- or at least 2 NPH insulin injections) plus mealtimes rapid acting insulin injections (Human or analogs) +/- oral hypoglycemic agents.
- 7,5% ≤ HbA1c ≤ 10%
- Patients able to perform self-monitoring blood glucose (SMBG) measurement and insulin injections.
- SMBG \> 3/day
Exclusion
- Diabetic retinopathy contraindicating glycemic control intensification
- Situation or pathology not allowing therapeutic education program (blindness, deafness, low language fluency…)
- Situation or pathology not allowing insulin therapy self-management and / or portable insulin pump use (rheumatologic pathology, low visual acuity, …)
- Recent (\<3 month) serious pathology
- Planned treatment or therapy able to induce long-term glycemic control worsening
- Long lasting (\> 2 month) planned treatment with glucocorticoids, octreotide, lanreotide or danazol
- Pregnancy wish or ongoing pregnancy
- Known Haemoglobinopathy.
- Creatinin clearance \<30ml/min (MDRD formula).
- Organ transplant.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00942318
Start Date
March 1 2009
End Date
February 1 2013
Last Update
December 11 2013
Active Locations (1)
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1
University Hospital Toulouse
Toulouse, France, 31059