Clinical trial NCT02910141: Individual Patient Data Meta-analysis of CSII vs. MDI in Type 2 Diabetes
Official title: 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: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
Continuous subcutaneous insulin infusion
Meta-analysis
Insulin pump therapy
Multiple daily insulin injections
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University of Leicester
name: University Hospital, Caen
First posted: 2016-09-21
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with type 2 diabetes

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.

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.

Primary outcomes:
measure: HbA1c
timeFrame: Up to 24 months
Secondary outcomes:
measure: Insulin dose
timeFrame: Up to 24 months
measure: Weight or BMI
timeFrame: Up to 24 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.