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Trial record 12 of 447 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02403375
Recruitment Status : Completed
First Posted : March 31, 2015
Last Update Posted : November 27, 2017
Sponsor:
Collaborator:
Roche Diabetes Care GmbH
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 Device: Accu-Chek Insight Pump System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Insight Kids Study: Reaching HbA1c Targets in Children and Adolescents With Type 1 Diabetes
Actual Study Start Date : May 17, 2015
Actual Primary Completion Date : October 26, 2017
Actual Study Completion Date : October 26, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Continuous Subcutaneous Insulin Infusion (CSII)
Continuous Subcutaneous Insulin Infusion (CSII) in Children and Adolescents 2-17 Years of Age
Device: Accu-Chek Insight Pump System
Continuous subcutaneous insulin infusion pump




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403375


Locations
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Austria
Medical University Graz
Graz, Austria, 8036
Universitatsklinik fur PadiatrieI, Padiatrische Diabetologie und Endokrinologie
Innsbruck, Austria, 6020
Medical University of Vienna-Dept of Pediatrics
Vienna, Austria, 1090
Germany
Kinderkrankenhaus auf der Bult
Hannover, Germany, 30173
Gemeinschaftspraxis für Kinder- und Jugendmedizin
Herford, Germany, 32051
Practice for Pediatric and Adolescent Diabetology
Munster, Germany, 48155
Universitatsklinikum Tubingen
Tubingen, Germany, 72076
United Kingdom
Birmingham Children's Hospital Foundation Trust
Birmingham, United Kingdom, B46NH
St. James's University Hospital
Leeds, United Kingdom, LS97TF
Sponsors and Collaborators
Hoffmann-La Roche
Roche Diabetes Care GmbH
Investigators
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Study Director: Cosima Rieger, Dr. Roche Diabetes Care GmbH

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02403375     History of Changes
Other Study ID Numbers: RD002177
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs