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

Diabetes Mellitus Type 1 Clinical Trial

— Insight Kids  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02403375
• Other study ID #: RD002177
• Status: Completed
• Phase: N/A
• First received: March 26, 2015
• Last updated: November 23, 2017
• Start date: May 17, 2015
• Est. completion date: October 26, 2017

Study information

• Verified date: November 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 26, 2017
• Est. primary completion date: October 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 1
• Diabetes Mellitus, Type 1

Intervention

Device:
• Accu-Chek Insight Pump System
Continuous subcutaneous insulin infusion pump

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz
Austria	Universitatsklinik fur PadiatrieI, Padiatrische Diabetologie und Endokrinologie	Innsbruck
Austria	Medical University of Vienna-Dept of Pediatrics	Vienna
Germany	Kinderkrankenhaus auf der Bult	Hannover
Germany	Gemeinschaftspraxis für Kinder- und Jugendmedizin	Herford
Germany	Practice for Pediatric and Adolescent Diabetology	Munster
Germany	Universitatsklinikum Tubingen	Tubingen
United Kingdom	Birmingham Children's Hospital Foundation Trust	Birmingham
United Kingdom	St. James's University Hospital	Leeds

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Roche Diabetes Care GmbH

Countries where clinical trial is conducted

Austria,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Score on Insulin Pump Questionnaire		26 weeks
Secondary	Score on Diabetes Treatment Satisfaction Questionnaire (DTSQ)		26 weeks
Secondary	Score on Pediatric Quality of Life Inventory (PedsQL)		26 weeks
Secondary	Change from Baseline in HbA1c		26 weeks
Secondary	Change from Baseline in Blood Glucose		26 weeks
Secondary	Number of Subjects, Who Report a Diabetes-Related Adverse Event (i.e., Symptomatic Hypoglycemia, Severe Hypoglycemia, Diabetic Ketoacidosis)		26 weeks