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The Steno Tech Survey: A Study of Insulin Pump Users With Type 1 Diabetes

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04311164
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
Nordsjaellands Hospital
Information provided by (Responsible Party):
Signe Schmidt, Steno Diabetes Center Copenhagen

Brief Summary:
This survey study seeks to contribute with new knowledge about the variation in clinical and psychosocial outcomes of people with Type 1 diabetes on insulin pump therapy. Potential sources of variation that are investigated in this study include both individual characteristics, such as demographics and socioeconomic status, and behavioral factors, such as psychological and preference structures. The study is conducted at two hospital sites in Denmark.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 1 Other: No intervention given.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Steno Tech Survey: A Multisite Exploratory Study of People With Type 1 Diabetes on Insulin Pump Therapy
Estimated Study Start Date : April 30, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort Intervention/treatment
Steno Tech Survey Respondents
This cohort is expected to consist of 1,400 people with Type 1 diabetes on insulin pump therapy treated at either Steno Diabetes Center Copenhagen or Nordsjællands Hospital Hilleroed.
Other: No intervention given.
Two survey questionnaires (T1 and T2). Each questionnaire is composed of multiple items including pre-coded (multiple choice) questions, dichotomous (yes/no) questions, rating scales and validated questionnaire scales to measure general and diabetes/insulin pump-specific behavior, psychosocial/psychological concepts and preferences.




Primary Outcome Measures :
  1. Glycated Hemoglobin A1c (HbA1c) [ Time Frame: 1 year: From April 2020 (first survey distribution) to April 2021 (second survey distribution) ]
    Information on HbA1c in mmol/mol will be extracted from patients' medical records


Secondary Outcome Measures :
  1. Psychological well-being [ Time Frame: 1 year: From April 2020 (first survey distribution) to April 2021 (second survey distribution) ]
    Measured with a questionnaire in the surveys

  2. Diabetes distress [ Time Frame: 1 year: From April 2020 (first survey distribution) to April 2021 (second survey distribution) ]
    Measured with a questionnaire in the surveys

  3. Self-reported diabetes and insulin pump-specific behavior [ Time Frame: 1 year: From April 2020 (first survey distribution) to April 2021 (second survey distribution) ]
    Measured with questionnaires in the surveys

  4. Educational preferences [ Time Frame: 1 year: From April 2020 (first survey distribution) to April 2021 (second survey distribution) ]
    Measured with questionnaires at T1 and discrete choice experiment at T2



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of adults (18+) with Type 1 diabetes on insulin pump therapy treated at either Steno Diabetes Center Copenhagen or Nordsjaellands Hospital (approximately 1,400 people).
Criteria

Inclusion criteria (for surveyed group):

  • Adult (18+ years)
  • Type 1 diabetes
  • Insulin pump user
  • Danish-speaking

Exclusion criteria (for surveyed group):

  • Child ([0;18[ years)
  • No access to Danish digital mail (e-Boks)
  • Non-Danish speaking

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): NCT04311164


Contacts
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Contact: Signe Schmidt, MD-PhD +4551174785 signeschmidt@regionh.dk
Contact: Kristoffer P. Madsen, MSc +4521351737 kristoffer.panduro.madsen@regionh.dk

Locations
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Denmark
Steno Diabetes Center Copenhagen Recruiting
Gentofte, Denmark, 2820
Contact: Signe Schmidt, MD-PhD    +4551174785    signe.schmidt@regionh.dk   
Contact: Kristoffer P. Madsen, MSc    +4521351737    kristoffer.panduro.madsen@regionh.dk   
Principal Investigator: Kirsten Nørgaard, MD-PhD         
Sub-Investigator: Karen Rytter         
Sub-Investigator: Ingrid W. Tapager         
Sub-Investigator: Henrik U. Andersen, MD-PhD         
Sub-Investigator: Eva Hommel, MD-PhD         
Sub-Investigator: Timothy C. Skinner, PhD         
Sub-Investigator: Bryan R. Cleal, PhD         
Sub-Investigator: Mette A. Nexø, PhD         
Nordsjællands Hospital Hillerød Recruiting
Hillerød, Denmark, 3400
Contact: Ulrik Pedersen-Bjergaard, MD-PhD    +4520823632    Ulrik.Pedersen-Bjergaard@regionh.dk   
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Nordsjaellands Hospital

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Responsible Party: Signe Schmidt, MD, PhD, Researcher, Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT04311164    
Other Study ID Numbers: Steno Tech Survey
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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