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

Roche

Status

Completed

Conditions

Diabetes Mellitus Type 1

Treatments

Device: Accu-Chek Insight Pump System

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02403375

RD002177

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

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)