Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections to Reach HbA1c Targets in Children and Adolescents With Type 1 Diabetes

NCT ID: NCT02403375

Last Updated: 2017-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-17
• Study Completion Date: 2017-10-26

Brief Summary

This study is to compare metabolic control, treatment satisfaction, and quality of life during continuous subcutaneous insulin infusion (CSII ) therapy with a new insulin pump system with multiple daily injections (MDI) therapy. Furthermore, this study will add clinical data originating from clinical investigation in a special population, i.e. children and adolescents of ages 2 - 17 years , to the existing clinical data of the ACCU-CHEK Insight insulin pump.

Conditions

Diabetes Mellitus Type 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Continuous Subcutaneous Insulin Infusion (CSII)

Continuous Subcutaneous Insulin Infusion (CSII) in Children and Adolescents 2-17 Years of Age

Group Type: EXPERIMENTAL

Accu-Chek Insight Pump System

Intervention Type: DEVICE

Continuous subcutaneous insulin infusion pump

Interventions

Accu-Chek Insight Pump System

Continuous subcutaneous insulin infusion pump

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Children and adolescents at least 24 months of age, and not more than 17 years of age at screening
• Diagnosed with type 1 diabetes
• Diagnosis of type 1 diabetes established > 6 months before study start if >5 years of age
• Indication for insulin pump therapy according to local guidelines
• Subject's most recent HbA1c is equal or above 7.0% (53.0 mmol/mol) - measured at last assessment before screening within the past 2 months prior to the Baseline Visit into the study
• Willingness to use automated bolus advice obtained from the Accu-Chek Insight diabetes therapy system during the study
• Willingness and ability to participate and comply with study procedures

Exclusion Criteria

• Disease or condition that in the opinion of the investigator is likely to affect compliance or the ability to complete the study
• Not willing or able to start insulin pump therapy
• Not willing to self-measure blood glucose at least four times daily
• Significantly impaired awareness of hypoglycemia
• More than one hospitalization for severe hypoglycemia during the last 12 months
• History of recurrent ketoacidosis during intensive insulin therapy
• Known strong plaster incompatibility and/or allergy
• Unstable chronic disease other than diabetes (e.g. impaired hepatic function, impaired renal function, impaired cardiac function, uncontrolled vascular complications) and any other condition interfering with the study procedures, as per Investigator´s discretion.
• If on antihypertensive, thyroid, anti-depressant or lipid-lowering medication, lack of stability on the medication for the past 2 months prior to the Baseline Visit in the study
• Chronic use of steroids in adrenal suppressive doses, other immuno-modulatory medication or chemotherapy
• Prescription medications other than insulin interfering with diabetes management
• Acute illness or abnormality (e.g. impaired vision, impaired motor function, acute pain) at the time of screening interfering with study procedures, affecting compliance, or the ability to complete the study as per Investigator´s discretion
• Either pregnant or breastfeeding
• Drug dependency
• Dependency on sponsor or Investigator (e.g. co-worker or family member)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Diabetes Care

INDUSTRY

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cosima Rieger, Dr.

Role: STUDY_DIRECTOR

Roche Diabetes Care

Locations

Medical University Graz

Graz, , Austria

Universitatsklinik fur PadiatrieI, Padiatrische Diabetologie und Endokrinologie

Innsbruck, , Austria

Medical University of Vienna-Dept of Pediatrics

Vienna, , Austria

Kinderkrankenhaus auf der Bult

Hanover, , Germany

Gemeinschaftspraxis für Kinder- und Jugendmedizin

Herford, , Germany

Practice for Pediatric and Adolescent Diabetology

Münster, , Germany

Universitatsklinikum Tubingen

Tübingen, , Germany

Birmingham Children's Hospital Foundation Trust

Birmingham, , United Kingdom

St. James's University Hospital

Leeds, , United Kingdom

Countries

Austria; Germany; United Kingdom

Other Identifiers

RD002177

Identifier Type: -

Identifier Source: org_study_id