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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: January 2016

Detailed Description

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.

Interventions

  • Device: Continuous subcutaneous insulin infusion
    • Infusion of short-acting insulin from a portable pump

Arms, Groups and Cohorts

  • CSII (subcutaneous insulin infusion)
    • People with Type 2 diabetes treated by continuous subcutaneous insulin infusion (CSII)
  • MDI (multiple daily insulin injections)
    • People with type 2 diabetes treated by multiple daily insulin injections

Clinical Trial Outcome Measures

Primary Measures

  • HbA1c
    • Time Frame: Up to 24 months
    • Difference in glycaemic control between treatments, as measured by HbA1c

Secondary Measures

  • Insulin dose
    • Time Frame: Up to 24 months
    • Difference in insulin dose between treatments
  • Weight or BMI
    • Time Frame: Up to 24 months
    • Difference in weight or BMI between treatments

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • King’s College London
  • Collaborator
    • University of Leicester
  • Provider of Information About this Clinical Study
    • Principal Investigator: Professor John Pickup, Emeritus Professor of Diabetes and Metabolism – King’s College London

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