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| Name | Class |
|---|---|
| University of Leicester | OTHER |
| University Hospital, Caen | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous subcutaneous insulin infusion | Device | Infusion of short-acting insulin from a portable pump |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Difference in glycaemic control between treatments, as measured by HbA1c | Up to 24 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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People with type 2 diabetes
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28428322 | Derived | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Up to 24 months |
| D004700 | Endocrine System Diseases |