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Completed

NCT Number: NCT02403375

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

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.

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Key information

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Accu-Chek Insight Pump System

Device

Continuous subcutaneous insulin infusion pump

Primary outcomes

  1. Percentage of Children and Adolescents of Ages 2 to 17 Years Reaching an HbA1c target of <7.5%

    Time frame: 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 outcomes

  1. Score on Insulin Pump Questionnaire

    Time frame: 26 weeks

  2. Score on Diabetes Treatment Satisfaction Questionnaire (DTSQ)

    Time frame: 26 weeks

  3. Score on Pediatric Quality of Life Inventory (PedsQL)

    Time frame: 26 weeks

  4. Change from Baseline in HbA1c

    Time frame: 26 weeks

  5. Change from Baseline in Blood Glucose

    Time frame: 26 weeks

  6. Number of Subjects, Who Report a Diabetes-Related Adverse Event (i.e., Symptomatic Hypoglycemia, Severe Hypoglycemia, Diabetic Ketoacidosis)

    Time frame: 26 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • Roche Diabetes Care

Registry information

Official study title

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

Acronym: Insight Kids

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 31, 2015
Registry last updated
Nov 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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