Trial document




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  DRKS00012645

Trial Description

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Title

„Online outpatient diabetes clinic for children and youth“

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Trial Acronym

ViDiKi

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URL of the Trial

http://www.kinderhormonzentrum-luebeck.uksh.de

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Brief Summary in Lay Language

The “virtual diabetes outpatient clinic for children and youth” (ViDiKi) is a German telemedicine study.

ViDiKi offers telemedicine as a new medical care for diabetic children using a continuous glucose monitoring system (CGM).


Families with a diabetic child receive monthly structured counselling regarding the glucose data and insulin therapy additionally to their regular care using online video consultation or phone/E-Mail.


The counselling process is based on the pump and CGM data, which can be uploaded into specific diabetes software and sent to the diabetes team via E-Mail.

So far, diabetes counselling was based on 4-8 blood glucose measurements per day, which offered only snapshots of the metabolic process. Insulin therapy was based on precognition regarding the anticipated glucose trends.


CGM technology analyses several hundred figures of glucose data per day and allows “real-time” analysis of glucose trends following meals, insulin shots or sports. Alarm signals offer protection against hypo- and hyperglycemia during day and night.

CGM systems will offer the possibility to optimize metabolic control especially in young children using a sensor-augmented pump therapy.

To reach that goal, more appointments ought to be offered. but not necessarily in an outpatient diabetes clinic.

Telemedicine offers a suitable way of discussing CGM and insulin pump data because the diabetic child does not need to be seen by a doctor. Telemedicine saves families time and the travelling costs to get to the outpatient clinic.

Telemedicine offers the opportunity to optimize quality of care for those using this new, expensive and helpful CGM technology.

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Brief Summary in Scientific Language

Multicenter evaluation concept with a waiting control;
quantitative and qualitative analysis and health economical analysis (mixed methods)

Sample size: 240 children
Primary endpoint: reduction in HbA1c
Secondary endpoints: glucose variability, quality of life, hospitalization, satisfaction with telemedicine

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Organizational Data

  •   DRKS00012645
  •   2017/07/19
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  •   yes
  •   Approved
  •   17-172, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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Health Condition or Problem studied

  •   E10 -  Type 1 diabetes mellitus
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Interventions/Observational Groups

  •   Intervention (treatment group): patients get online support additionally to usual diabetes care right from the beginning in the form of monthly structured counselling regarding the glucose data and insulin therapy additionally to their regular care using online video consultation or phone/E-Mail.
    The counselling process is based on the pump and CGM data (continuous glucose monitoring system), which can be uploaded into specific diabetes software and sent to the diabetes team via E-Mail.
  •   Waiting control group gets online support additionally to usual diabetes care six months after inclusion to trial
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Multicenter evaluation concept with a waiting control; quantitative and qualitative analysis and health economical analysis (mixed-methods)

Sample size: 240 children
Primary endpoint: reduction in HbA1c

Collection-HbA1c-values
01. Three months before inclusion to trial
02. Inclusion to trial
03. Every three months until the end of the trial

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Secondary Outcome

Secondary endpoints: glucose variability, quality of life, hospitalization, satisfaction with telemedicine

Quality of life Questionnaire
KINDL-R
WHO-5

Satisfaction Diabetes Questionnaire
Diabetes Treatment Satisfaction Questionnaire

First data collection at inclusion to trial and then every 6 months until the end of the trial

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2017/07/01
  •   240
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   1   Years
  •   17   Years
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Additional Inclusion Criteria

Prerequisites: CGM system with or without alarm function, MDI or insulin pump, sufficient Germen, English or Turkish language skills, willingness to participate in a 12-month telemedicine study.
Technical prerequisites are: desktop or laptop, internet access at home, basic knowledge how to send an Email with an attached file
Furthermore, participating children must be insured in one of the participating state health insurances

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Exclusion Criteria


Coding
1 = no interest in the study
2 = objection to data security
3 = insufficient or missing technical setting (internet)
4 = worry about use of technology
5 = state health insurance does not participate in the study
6 = too young < 1 year to participate
7 = diabetes onset < 6 months ago
8 = Treatment from a diabetologist not practicing in Schleswig-Holstein state
9 = Language issue (no sufficient German, Turkish or English)
10 = one parent, child or legal guardian rejects study participation
11= patient had already had four telemedicine appointments with consultation or participated in a telemedicine study in the past

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Addresses

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    • Universittätsklinikum Schleswig-Holstein (UKSH), Campus Lübeck, Klinik für Kinder und Jugendmedizin, Sektion Pädiatrische Endokrinologie und -diabetologie
    • Ms.  Dr. med.  Simone  von Sengbusch 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • AOK NORDWEST (Konsortialpartner), weitere Gesetzliche Krankenversicherungen Barmer, DAK, TK, IKK Nord, BKKs
    • Ms. 
    • Germany
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    • Universität zu LübeckZentrum für Bevölkerungsmedizin und Versorgungsforschung
    • Mr.  Dr. jur.  Fabian-S.  Frielitz,LL.M.,M.A.,MBA 
    • Ratzeburger Allee 160, Haus 50
    • 23562  Lübeck
    • Germany
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    • Universitätsklinikum Schleswig-Holstein (UKSH), Campus LübeckKlinik für Kinder- und Jugendmedizin, Sektion Pädiatrische Endokrinologie und –diabetologie
    • Ms.  Dr.  Simone  Sengbusch 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Universitätsklinikum Schleswig-Holstein (UKSH), Campus LübeckKlinik für Kinder- und Jugendmedizin, Sektion Pädiatrische Endokrinologie und –diabetologie
    • Ms.  Dr. med.  Simone  von Sengbusch 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • DLR Projektträger - Bereich Gesundheit -; Förderung aus Mitteln des Innovationsfonds (GBA) zur Förderung von neuen Versorgungsformen (§92a SGB V)
    • Heinrich-Konen-Straße 1
    • 53227  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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