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

Not Applicable

Completed

• Conditions: Diabetes Mellitus Type 1
• Interventions: Device: Accu-Chek Insight Pump System

• Registration Number: NCT02403375
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-26
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-31
• Study Start: 2015-05-17
• Primary Completion: 2017-10-26
• Study Completion: 2017-10-26
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-23
• Last Update Posted: 2017-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Continuous Subcutaneous Insulin Infusion (CSII)	Accu-Chek Insight Pump System	Continuous Subcutaneous Insulin Infusion (CSII) in Children and Adolescents 2-17 Years of Age

Primary Outcome Measures

Name	Time	Method
Percentage of Children and Adolescents of Ages 2 to 17 Years Reaching an HbA1c target of <7.5%	26 weeks	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%.

Secondary Outcome Measures

Name	Time	Method
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
Number of Subjects, Who Report a Diabetes-Related Adverse Event (i.e., Symptomatic Hypoglycemia, Severe Hypoglycemia, Diabetic Ketoacidosis)	26 weeks
Change from Baseline in Blood Glucose	26 weeks

Trial Locations

Locations (9)

Medical University Graz; 🇦🇹 Graz, Austria

Kinderkrankenhaus auf der Bult; 🇩🇪 Hannover, Germany

Medical University of Vienna-Dept of Pediatrics; 🇦🇹 Vienna, Austria

Gemeinschaftspraxis für Kinder- und Jugendmedizin; 🇩🇪 Herford, Germany

Practice for Pediatric and Adolescent Diabetology; 🇩🇪 Munster, Germany

Universitatsklinikum Tubingen; 🇩🇪 Tubingen, Germany

St. James's University Hospital; 🇬🇧 Leeds, United Kingdom

Birmingham Children's Hospital Foundation Trust; 🇬🇧 Birmingham, United Kingdom

Universitatsklinik fur PadiatrieI, Padiatrische Diabetologie und Endokrinologie; 🇦🇹 Innsbruck, Austria