Patient With Type 2 Diabetes Treated With Insulin Using a Baseline/Bolus Strategy
Conditions
Brief summary
This is an open multicentre, randomized study to compare two treatment arms. One arm called intensification of multiple injections in which the patient will receive one supplementary injection of LEVEMIR®: that is to say 5 injections per day, and an arm called continuous insulin infusion via an external pump with APIDRA®. In the pump arm: a favorable effect in terms of improved insulin sensitivity, improved metabolic equilibrium, a decrease in the area under the baseline and prandial hyperglycemia curve noted during the continuous glycemia recording; an improvement in quality of life compared with treatment using multiple injections.
Sponsors
Centre Hospitalier Universitaire Dijon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Persons who have provided written informed consent * Age \> 18 years * Patients with type 2 diabetes treated with insulin using a basal / bolus strategy for at least 6 months * Doses of insulin \> 0.7 U / Kg / d * HbA1c ≥ 7.5 % * Without OAD for at least 4 weeks (sulfamides, Incretines, glinides, acarbose) except Metformin * BMI ≥ 28.5 kg / m2 * Diabetes diagnosed for at least 10 years * Patients able to monitor themselves and manage an insulin pump.
Exclusion criteria
* Patients treated with glitazones during the 3 months preceding inclusion * Patients with proliferative ischemic retinopathy not treated by laser * BMI \< 28.5 kg / m2 * Presence of implantable material ( CI MRI ) * Pacemaker ( CI MRI ) * Pregnancy, breast feeding * Medically significant physical or psychiatric inability, patients under guardianship or wards of court * The practice of violent sports * Poor conditions of hygiene * Professional environment of extreme cold or heat.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mixed measurement of insulin secretion and insulin resistance | Change from baseline insulin secretion and insuline resistance at 6 month after starting the treatment |
Secondary
| Measure | Time frame |
|---|---|
| Decrease in the time spent in baseline and prandial hyperglycemia | During the 6 months following initiation of the treatment |
Countries
France
Outcome results
None listed