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

Study Overview
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Brief Summary
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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%).

Detailed Description
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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.

Official Title
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Efficacy of Continuous Subcutaneous Insulin Infusion Versus Basal-bolus Multiple Daily Injections Regimen in Type 2 Diabetes: a One Year, Randomised, Parallel Study

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Detemir insulin, Aspart insulin, Metformin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PPE<br>PPE : CSII +/- Metformin. | Drug: Detemir insulin, Aspart insulin, Metformin<br>* Insulin doses adapted by patients according to self monitoring blood glucose results.<br>|
| Active Comparator: injections<br>INJ: basal/bolus MDI +/- Metformin | Drug: Detemir insulin, Aspart insulin, Metformin<br>* Insulin doses adapted by patients according to self monitoring blood glucose results.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight, waist perimeter, BP, triglycerides, total cholesterol, HDL and LDL cholesterol ; QOL, physical activity, treatment satisfaction and eating habits questionnaire. |  | 12 months | 
| self monitoring blood glucose measurements (frequency, mean and standard deviation, number of hypoglycaemic and hyperglycaemic events) |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Continuous subcutaneous insulin infusion, Insulin external pump, Multiple daily injections, Basal-bolus regimen, Education