E10 E11
Conditions
Interventions
Group 1: Adults (>18 years) with Diabetes mellitus type 1
Adolescents (13-18 years) with Diabetes mellitus type 1
Parents of children (0-12 years) with Diabetes mellitus type 1
- Visit 1: before sta
Sponsors
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IDT)
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Inclusion criteria
Inclusion criteria: - Gender: male and female - Minimum Age: 0-12 years (children of participating parents), 13 years (adolescent) - Maximum Age: no maximum age - Willingness to participate in the study after informed consent was signed - Indication for the use of an rtCGM system - Readiness for continuous use of rtCGM over 8 months - Intensive insulin therapy (MDI or CSII) (no fixed ratio of CSII to ICT)
Exclusion criteria
Exclusion criteria: - Previous rtCGM Training - inability to comply with the study procedures as described by the study protocol, according to the opinion of the investigator, due to e.g. known psychiatric diagnoses, lack of cognitive ability, alcohol dependency, drug use, psychosocial overload
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The knowledge and competencies of the trained patients are assessed in a combined knowledge and practical competency test for rtCGM. The 40-item test requires central cognitive contents to be communicated to rtCGM in SPECTRUM (e.g., time delay between tissue and blood glucose, meaning of the trend arrows, reactions to specific trend/ glucose constellation, error messages). In addition, the participants are asked to demonstrate central practical learning objectives in the sense of an OSCE (objective structured clinical examination), e.g. insertion of the glucose sensor in a hygienic manner, calibrating the system, making central settings with the rtCGM system, making insulin dose adjustments. A 30% increase in knowledge of and competences in rtCGM (by 80% of the participants pre-topost training scores) should take place. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Satisfaction with the training program SPECTRUM (structured questionnaire based on Lange et al. 2001) • Satisfaction/ burden of rtCGM usage (Satisfaction Questionnaire, based on van Bohm et al. 2011) • Satisfaction with diabetic therapy (DTSQc, Bradley et al. 2007) • Fear of Hypoglycemia questionnaire (Haugstvedt et al. 2011; Gonder-Frederik et al. 2011) • Drop-out rate after 6 months • Number of severe hypoglycemic events (coma/ seizure) 6 months before the start of the rtCGM vs. 6 months after rtCGM training • Duration of the time within target range (“time in range” (TiR); 70 - 180 mg / dl) during the first week with rtCGM vs. TiR over 7 days 6 months after the training in rtCGM (data to be downloaded by the participating practices) • HbA1c at start of training and 6 months after the training (measured in the laboratory of the participating practices) | — |
Countries
Germany
Contacts
Public ContactSandra Schlüter
Diabetespraxis Northeim
Outcome results
None listed