Clinical trial NCT02403375: Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections to Reach HbA1c Targets in Children and Adolescents With Type 1 Diabetes
Official title: Insight Kids Study: Reaching HbA1c Targets in Children and Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 1
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Roche Diabetes Care
First posted: 2015-03-31
Enrollment: 43
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: Percentage of Children and Adolescents of Ages 2 to 17 Years Reaching an HbA1c target of <7.5%
timeFrame: 26 weeks
Secondary outcomes:
measure: Score on Insulin Pump Questionnaire
timeFrame: 26 weeks
measure: Score on Diabetes Treatment Satisfaction Questionnaire (DTSQ)
timeFrame: 26 weeks
measure: Score on Pediatric Quality of Life Inventory (PedsQL)
timeFrame: 26 weeks
measure: Change from Baseline in HbA1c
timeFrame: 26 weeks
measure: Change from Baseline in Blood Glucose
timeFrame: 26 weeks
measure: Number of Subjects, Who Report a Diabetes-Related Adverse Event (i.e., Symptomatic Hypoglycemia, Severe Hypoglycemia, Diabetic Ketoacidosis)
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
city: Innsbruck
country: Austria
facility: Universitatsklinik fur PadiatrieI, Padiatrische Diabetologie und Endokrinologie
city: Vienna
country: Austria
facility: Medical University of Vienna-Dept of Pediatrics
city: Hannover
country: Germany
facility: Kinderkrankenhaus auf der Bult
city: Herford
country: Germany
facility: Gemeinschaftspraxis für Kinder- und Jugendmedizin
city: Munster
country: Germany
facility: Practice for Pediatric and Adolescent Diabetology
city: Tubingen
country: Germany
facility: Universitatsklinikum Tubingen
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital Foundation Trust
city: Leeds
country: United Kingdom
facility: St. James's University Hospital
Study officials:
affiliation: Roche Diabetes Care
name: Cosima Rieger, Dr.
role: STUDY_DIRECTOR
References: