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| ID | Type | Description | Link |
|---|---|---|---|
| WA 2929/2-1/ AOBJ 582855 | Other Grant/Funding Number | German Research Foundation |
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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
| Roche Diagnostics GmbH | INDUSTRY |
| University of Luebeck | OTHER |
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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.
Children and adolescents currently treated with MDI and with an indication for CSII were randomized 1:1 to either starting with CSII as soon as possible or to continuing MDI while waiting six months for transmission to CSII, stratified by center. The primary outcomes were patient-reported diabetes-specific health-related quality of life , and diabetes burden of the main caregiver. We also investigated the impact of CSII on main caregiver stress, psychological well-being, fear of hypoglycemia, main caregiver's and adolescent's treatment satisfaction, family conflict, and HbA1c.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin pump therapy (CSII) | Experimental | Continuous subcutaneous insulin infusion therapy using different devices with marketing approval and different insulins |
|
| Multiple daily injection therapy (MDI) | Active Comparator | Multiple daily injection therapy using different devices with marketing approval and different insulin types |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous subcutaneous insulin infusion therapy | Device | Insulin is given continuously using an insulin pump. Devices are allowed having marketing approval. Insulins are permitted with marketing approval. |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life (HRQOL) (patient) | Child's HRQOL will be measured using the well-known standardized KINDL-R (KINDL) modular questionnaire. The widely used instrument provides a generic age-appropriate core-measure (24 items) and a diabetes-specific module (21 items). | 6 months |
| Diabetes burden (main carer) | The main carer (parent) will report on the Overall Diabetes Burden using a one-dimensional 5-point intensity scale which was used in the pilot-study and showed sensitivity to change. Comment: Two primary measures are used because independent information from the child (patient) and the main carer is requested | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Parental stress level | Parental stress will be measured using the Paediatric Inventory for Parents (PIP). The 42-items instrument provides a Total Frequency Score (PIP-F), and a Total Difficulty Score (PIP-D) | 6 months |
| Hypoglycemia fear (main carer) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Verena Wagner, MD | University Hospital Schleswig-Holstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endokrinologikum Berlin | Berlin | 10117 | Germany | |||
| Kinderklinik Charite |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30302877 | Derived | Mueller-Godeffroy E, Vonthein R, Ludwig-Seibold C, Heidtmann B, Boettcher C, Kramer M, Hessler N, Hilgard D, Lilienthal E, Ziegler A, Wagner VM; German Working Group for Pediatric Pump Therapy (agip). Psychosocial benefits of insulin pump therapy in children with diabetes type 1 and their families: The pumpkin multicenter randomized controlled trial. Pediatr Diabetes. 2018 Dec;19(8):1471-1480. doi: 10.1111/pedi.12777. Epub 2018 Oct 10. |
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open multicentre parallel randomised controlled intervention trial with waiting-list-control-group
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| Multiple daily injection therapy | Device | Multiple daily injection therapy with different devices and insulin types. Devices and insulin types have to have marketing approval. |
|
Hypoglycemia fear will be measured using the Hypoglycaemia Fear Survey, parent version (HFS-P, Clarke et al. 1998). The 25-items instrument provides two scales: Behaviour and Worry
| 6 months |
| Family conflicts | Family conflict (adolescent, main carer) will be measured by the Diabetes Family Conflict Scale (DFCS). The 19 items instrument provides a DFCS Total Score | 6 months |
| HbA1c | Blood samples will be collected locally with standardised equipment.The mean HbA1c value will be calculated for each patient from the last 3 measurements taken during the past six months. HbA1c values will be mathematically standardized to the Diabetes Control and Complications Trial (DCCT) -equivalent in agreement with published guidelines (Marshall& Barth 2000) | 6 months |
| Severe Hypoglycemia International Society for Pediatric and Adolescent Diabetes (ISPAD) II/III | Severe hypoglycaemia grade II and grade III will be documented according to ISPAD guidelines | 6 months |
| Diabetes treatment satisfaction | Treatment Satisfaction will be measured using the Diabetes Treatment Satisfaction Scale, status version (DTSQs-teen, DTSQs-parent).The validated German version will be released by MAPI (MAPI) in April 2011. | 6 months |
| Berlin |
| 13353 |
| Germany |
| Klinik für Kinder- und Jugendmedizin, Ruhr-Universität-Bochum | Bochum | 44791 | Germany |
| Kinderkrankenhaus Kliniken der Stadt Köln GmbH | Cologne | 50735 | Germany |
| PRIMA Kinderkliniken Darmstadt | Darmstadt | 64287 | Germany |
| Marienhospital / Kinderklinik | Gelsenkirchen | 45138 | Germany |
| Universitätsklinik Gießen | Giessen | 35392 | Germany |
| Klinik am Eichert | Göppingen | 73035 | Germany |
| Kinderkrankenhaus Wilhelmstift | Hamburg | 22149 | Germany |
| Altonaer Kinderkrankenhaus | Hamburg | 22763 | Germany |
| Gemeinschaftskrankenhaus | Herdecke | 58313 | Germany |
| Praxis für Kinder- und Jugendmedizin | Herford | 32052 | Germany |
| Kinderklinik Städt. Klinikum | Karlsruhe | 76133 | Germany |
| UK-SH, Klinik für Allg. Pädiatrie | Kiel | 24105 | Germany |
| Universität Leipzig, Kinderklinik | Leipzig | 04103 | Germany |
| UK SH Campus Lübeck, Klinik für Kinder- und Jugendmedizin | Lübeck | 23538 | Germany |
| Ev.Krankenhaus | Oberhausen | 46047 | Germany |
| Kinderhospital Osnabrück | Osnabrück | 49082 | Germany |
| Klinik f. Kinder- und Jugendmedizin | Ravensburg | 88212 | Germany |
| Universitäts- Kinder- und Jugendklinik | Rostock | 18057 | Germany |
| Bethlehem Gesundheitszentrum Stolberg | Stolberg | 52222 | Germany |
| Olgahospital | Stuttgart | 70176 | Germany |
| Universitätsklinik Tübingen | Tübingen | 72706 | Germany |
| HSK-Kinderklinik | Wiesbaden | 65199 | Germany |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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