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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Device: Continuous subcutaneous insulin infusion

• Registration Number: NCT02910141
• Lead Sponsor: King's College London

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2016-01
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-18
• Study First Posted: 2016-09-21
• Study Completion: 2016-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 590

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CSII (subcutaneous insulin infusion)	Continuous subcutaneous insulin infusion	People with Type 2 diabetes treated by continuous subcutaneous insulin infusion (CSII)

Primary Outcome Measures

Name	Time	Method
HbA1c	Up to 24 months	Difference in glycaemic control between treatments, as measured by HbA1c

Secondary Outcome Measures

Name	Time	Method
Insulin dose	Up to 24 months	Difference in insulin dose between treatments
Weight or BMI	Up to 24 months	Difference in weight or BMI between treatments