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Psychosocial Issues in Insulin Pump Therapy in Children With Type 1 Diabetes Mellitus (DM)
Psychosocial Issues in Insulin Pump Therapy in Children With Type 1 Diabetes Mellitus (DM)

NCT01338922

CompletedNA

Sponsor: University Hospital Schleswig-Holstein

Conditions: Diabetes Mellitus, Insulin-Dependent

Interventions: Continuous subcutaneous insulin infusion therapy, Multiple daily injection therapy

Countries: Germany

The effect of change in diabetes treatment from multiple daily insulin injection therapy to continuous subcutaneous insulin infusion on psychosocial outcome measures (quality of life, diabetes burden, parents stress level, fear, family conflicts) in families with children and adolescents with diabetes mellitus type 1 have been analysed. Additionally the effect on metabolic parameters (HbA1c, severe Hypoglycemia, Ketoacidosis) have been analysed.

Eligibility overview

Sex: ALL

Age: 6 Years to 16 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Type 1 DM
* Transition to Continuous Subcutaneous Insulin Infusion (CSII)
* meeting the costs by health services
* sufficient German literacy

Exclusion Criteria:

* Remission (diabetes duration \< 6 months, insulin \< 0.5 i.E./kg)
* severe learning problems
* Investigator's children
* Waiting time not advised for medical reasons
Locations (24)
  • Berlin, Germany
  • Berlin, Germany
  • Bochum, Germany
  • Cologne, Germany
  • Darmstadt, Germany
  • Gelsenkirchen, Germany
  • Giessen, Germany
  • Göppingen, Germany
  • Hamburg, Germany
  • Hamburg, Germany
  • Herdecke, Germany
  • Herford, Germany
  • Karlsruhe, Germany
  • Kiel, Germany
  • Leipzig, Germany
  • Lübeck, Germany
  • Oberhausen, Germany
  • Osnabrück, Germany
  • Ravensburg, Germany
  • Rostock, Germany
  • Stolberg, Germany
  • Stuttgart, Germany
  • Tübingen, Germany
  • Wiesbaden, Germany