Individual Patient Data Meta-analysis of CSII vs. MDI in Type 2 Diabetes

Study Overview
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Brief Summary
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This study aims to compare glycaemic control during continuous subcutaneous insulin fusion (CSII, insulin pump therapy) and multiple daily insulin injections in type 2 diabetes and to identify patient-level characteristics that predict the best improvement in control and any change in insulin dose or other outcome.

Detailed Description
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The investigators will identify randomised controlled trials without language restriction that meet the inclusion criteria by searching the Cochrane database, Ovid Medline, Google Scholar and other sources. The investigators will exclude observational studies, short-term trials <2 months duration, studies in pregnant diabetic subjects, newly diagnosed type 2 diabetes, trials in type 1 diabetes and extensions of previous studies. Data on individual participants will be obtained directly from trialists and from funding sponsors who hold the trial data and will include age, sex, duration of diabetes, treatment group, baseline and final HbA1c, baseline and final insulin dose, baseline and final BMI. A 'two-step' meta-analysis will be performed to estimate overall mean differences in HbA1c, insulin dose and weight/BMI for the trials. Then, a 'one-step' meta-regression analysis will be conducted by creating a single large dataset from the individual patient data. Determinants of final HbA1c, BMI/weight and insulin dose will be explored using Bayesian approaches with covariates that include baseline HbA1c, age, diabetes duration, BMI, insulin dose and interactions between the covariates.

Official Title
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Individual Patient Data Meta-analysis of Randomised Controlled Trials Comparing Glycaemic Control During Continuous Subcutaneous Insulin Infusion vs. Multiple Daily Insulin Injections in Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Continuous subcutaneous insulin infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: RCTs of CSII vs. MDI in type 2 diabetes, study duration at least 2 months, non-pregnant Exclusion Criteria: Type 1 diabetes, studies <2 months duration, pregnant women, newly diagnosed type 2 diabetes and extensions of previous studies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CSII (subcutaneous insulin infusion)<br>People with Type 2 diabetes treated by continuous subcutaneous insulin infusion (CSII) | Device: Continuous subcutaneous insulin infusion<br>* Infusion of short-acting insulin from a portable pump<br>* Other names: Insulin pump therapy;|
| MDI (multiple daily insulin injections)<br>People with type 2 diabetes treated by multiple daily insulin injections | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Difference in glycaemic control between treatments, as measured by HbA1c | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin dose | Difference in insulin dose between treatments | Up to 24 months | 
| Weight or BMI | Difference in weight or BMI between treatments | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, Continuous subcutaneous insulin infusion, Meta-analysis, Insulin pump therapy, Multiple daily insulin injections