Overview

Efficacy of Continuous Subcutaneous Insulin Infusion Versus Basal-bolus Multiple Daily Injections Regimen in Type 2 Diabetes

Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
0
Participant gender:
All
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), using an external pump, could be a solution to improve diabetes control. The aim of this study is to compare, over a one-year period, the efficacy of CSII (with aspart insulin) and basal-bolus multiple daily injections (MDI) treatment (with detemir x 2/d and aspart before meals) in type 2 diabetic patients, already treated by basal-bolus regimen for at least 6 months, who didn't reach adequate target for glycemic at baseline (HbA1c>7 -10%).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Toulouse
Treatments:
Insulin
Insulin Aspart
Insulin, Globin Zinc
Metformin
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.