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

NCT02403375 | Completed

• 1 other identifier: RD002177
• Study Type: interventional
• Target: 43
• Locations: 3 countries
• Sites: 9

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Children and Adolescents of Ages 2 to 17 Years Reaching an HbA1c target of <7.5%

  This HbA1c target of \<7.5% proportion is statistically tested against a proportion of 25%, composed of the anticipated population proportion of 15% of children and adolescents using multiple daily insulin injections plus a safety margin of 10%.

  26 weeks

Secondary Outcomes (6)

• Score on Insulin Pump Questionnaire

  26 weeks

• Score on Diabetes Treatment Satisfaction Questionnaire (DTSQ)

  26 weeks

• Score on Pediatric Quality of Life Inventory (PedsQL)

  26 weeks

• Change from Baseline in HbA1c

  26 weeks

• Change from Baseline in Blood Glucose

  26 weeks

Study Arms (1)

Continuous Subcutaneous Insulin Infusion (CSII)

EXPERIMENTAL

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

Device: Accu-Chek Insight Pump System

Interventions

Accu-Chek Insight Pump System DEVICE

Continuous subcutaneous insulin infusion pump

Continuous Subcutaneous Insulin Infusion (CSII)

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Roche Diabetes Care: collaborator

Study Sites (9)

Medical University Graz

Graz, 8036, Austria

Location

Universitatsklinik fur PadiatrieI, Padiatrische Diabetologie und Endokrinologie

Innsbruck, 6020, Austria

Location

Medical University of Vienna-Dept of Pediatrics

Vienna, 1090, Austria

Location

Kinderkrankenhaus auf der Bult

Hanover, 30173, Germany

Location

Gemeinschaftspraxis für Kinder- und Jugendmedizin

Herford, 32051, Germany

Location

Practice for Pediatric and Adolescent Diabetology

Münster, 48155, Germany

Location

Universitatsklinikum Tubingen

Tübingen, 72076, Germany

Location

Birmingham Children's Hospital Foundation Trust

Birmingham, B46NH, United Kingdom

Location

St. James's University Hospital

Leeds, LS97TF, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Cosima Rieger, Dr.

  Roche Diabetes Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: March 31, 2015
• Study Start: May 17, 2015
• Primary Completion: October 26, 2017
• Study Completion: October 26, 2017
• Last Updated: November 27, 2017

Record last verified: 2017-11

Locations

AU (3); DE (4); GB (2)