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

NCT ID: NCT02910141

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 590 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-12-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

CSII (subcutaneous insulin infusion)

People with Type 2 diabetes treated by continuous subcutaneous insulin infusion (CSII)

Continuous subcutaneous insulin infusion

Intervention Type: DEVICE

Infusion of short-acting insulin from a portable pump

MDI (multiple daily insulin injections)

People with type 2 diabetes treated by multiple daily insulin injections

No interventions assigned to this group

Interventions

Continuous subcutaneous insulin infusion

Infusion of short-acting insulin from a portable pump

Intervention Type: DEVICE

Other Intervention Names

Insulin pump therapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leicester

OTHER

Sponsor Role: collaborator

University Hospital, Caen

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Professor John Pickup

Emeritus Professor of Diabetes and Metabolism

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Pickup JC, Reznik Y, Sutton AJ. Glycemic Control During Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Insulin Injections in Type 2 Diabetes: Individual Patient Data Meta-analysis and Meta-regression of Randomized Controlled Trials. Diabetes Care. 2017 May;40(5):715-722. doi: 10.2337/dc16-2201.

Reference Type: DERIVED

PMID: 28428322 (View on PubMed)

Other Identifiers

IPDMetaT2

Identifier Type: -

Identifier Source: org_study_id