NCT02910141

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
590

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

September 12, 2016

Last Update Submit

March 1, 2017

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetesContinuous subcutaneous insulin infusionMeta-analysisInsulin pump therapyMultiple daily insulin injections

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Difference in glycaemic control between treatments, as measured by HbA1c

    Up to 24 months

Secondary Outcomes (2)

  • Insulin dose

    Up to 24 months

  • Weight or BMI

    Up to 24 months

Study Arms (2)

CSII (subcutaneous insulin infusion)

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

Device: Continuous subcutaneous insulin infusion

MDI (multiple daily insulin injections)

People with type 2 diabetes treated by multiple daily insulin injections

Interventions

Continuous subcutaneous insulin infusionDEVICE

Infusion of short-acting insulin from a portable pump

Also known as: Insulin pump therapy
CSII (subcutaneous insulin infusion)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with type 2 diabetes

You may qualify if:

  • RCTs of CSII vs. MDI in type 2 diabetes, study duration at least 2 months, non-pregnant

You may not qualify if:

  • Type 1 diabetes, studies \<2 months duration, pregnant women, newly diagnosed type 2 diabetes and extensions of previous studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28428322DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emeritus Professor of Diabetes and Metabolism

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 21, 2016

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

December 1, 2016

Last Updated

March 3, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share