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

Insight Kids Study: Reaching HbA1c Targets in Children and Adolescents With Type 1 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 1
• Intervention / Treatment: Device: Accu-Chek Insight Pump System

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medical University Graz
  • Innsbruck, Austria, 6020
    • Universitatsklinik fur PadiatrieI, Padiatrische Diabetologie und Endokrinologie
  • Vienna, Austria, 1090
    • Medical University of Vienna-Dept of Pediatrics
• Germany
  • Hannover, Germany, 30173
    • Kinderkrankenhaus auf der Bult
  • Herford, Germany, 32051
    • Gemeinschaftspraxis für Kinder- und Jugendmedizin
  • Munster, Germany, 48155
    • Practice for Pediatric and Adolescent Diabetology
  • Tubingen, Germany, 72076
    • Universitätsklinikum Tübingen
• United Kingdom
  • Birmingham, United Kingdom, B46NH
    • Birmingham Children's Hospital Foundation Trust
  • Leeds, United Kingdom, LS97TF
    • St. James's University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Subcutaneous Insulin Infusion (CSII); Continuous Subcutaneous Insulin Infusion (CSII) in Children and Adolescents 2-17 Years of Age	Device: Accu-Chek Insight Pump System; Continuous subcutaneous insulin infusion pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Number of Subjects, Who Report a Diabetes-Related Adverse Event (i.e., Symptomatic Hypoglycemia, Severe Hypoglycemia, Diabetic Ketoacidosis)	26 weeks

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Roche Diabetes Care GmbH
• Investigators: Study Director: Cosima Rieger, Dr., Roche Diabetes Care GmbH

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2015
• Primary Completion (Actual): October 26, 2017
• Study Completion (Actual): October 26, 2017

Study Registration Dates

• First Submitted: March 26, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Actual): November 27, 2017
• Last Update Submitted That Met QC Criteria: November 23, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: RD002177

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No