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

Toulouse University Hospital

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Detemir insulin, Aspart insulin, Metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT00942318

AOL 2008

0816202

Details and patient eligibility

About

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%).

Full 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 pump between V2 and V3.

Visit 3: 5-day's hospitalisation. Start of CSII or MDI treatments. Stop of all oral diabetic medications except for metformin, which is followed up until the end of the study. Teaching program on diabetes management (diet, physical activity and self-adjustment of insulin doses). HbA1c, clinical and biological parameters. Questionnaires.

Follow-up visits 4-7 (1, 3, 6, 9 months): HbA1c. Treatment adjustment. Adverse events collection.

Final visit (12 months): HbA1c, clinical and biological parameters. Questionnaires. Adverse events collection.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.