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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02403375
• Date of registration: 26/03/2015
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections to Reach HbA1c Targets in Children and Adolescents With Type 1 Diabetes Insight Kids
• Scientific title: Insight Kids Study: Reaching HbA1c Targets in Children and Adolescents With Type 1 Diabetes
• Date of first enrolment: May 17, 2015
• Target sample size: 43
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02403375
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria, Germany, United Kingdom

Contacts

• Name: Cosima Rieger, Dr.
• Affiliation: Roche Diabetes Care GmbH

Key inclusion & exclusion 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)



Age minimum: 2 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus Type 1

Intervention(s)

Device: Accu-Chek Insight Pump System

Primary Outcome(s)

Percentage of Children and Adolescents of Ages 2 to 17 Years Reaching an HbA1c target of <7.5% [Time Frame: 26 weeks]

Secondary Outcome(s)

Score on Insulin Pump Questionnaire [Time Frame: 26 weeks]

Change from Baseline in Blood Glucose [Time Frame: 26 weeks]

Change from Baseline in HbA1c [Time Frame: 26 weeks]

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

Score on Diabetes Treatment Satisfaction Questionnaire (DTSQ) [Time Frame: 26 weeks]

Score on Pediatric Quality of Life Inventory (PedsQL) [Time Frame: 26 weeks]

Secondary ID(s)

RD002177

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Roche Diabetes Care GmbH