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Steno Tech Explore: 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04311164
Recruitment Status : Completed
First Posted : March 17, 2020
Last Update Posted : February 1, 2021
Sponsor:
Collaborator:
Nordsjaellands Hospital
Information provided by (Responsible Party):
Signe Schmidt, Steno Diabetes Center Copenhagen

Study Description
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Brief Summary:
The present study is part of an overarching study being conducted in Denmark at Steno Diabetes Center Copenhagen (SDCC) and Nordsjællands Hospital Hillerød (NOH), Steno Tech, that aims to develop and ultimately, in a randomized controlled trial (RCT), test approaches that can assist people with type 1 diabetes in obtaining optimal outcomes using CSII. Through a large-scale, questionnaire-based online survey enriched with data from national registers, this sub-study contributes to this overarching aim by exploring the importance of individual differences across a wide range of factors, including demographic, socioeconomic, health status, psychosocial and preference structures, for optimal use of CSII in people with type 1 diabetes.

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

Detailed Description:
See attached protocol for a detailed description.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 770 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Steno Tech Explore: A Multisite Exploratory Study of People With Type 1 Diabetes on Insulin Pump Therapy
Actual Study Start Date : May 15, 2020
Actual Primary Completion Date : October 15, 2020
Actual Study Completion Date : October 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Groups and Cohorts
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Group/Cohort Intervention/treatment
Steno Tech Survey Respondents
A cohort of individuals with type 1 diabetes treated with CSII at either SDCC or NOH participating in the Steno Tech Survey.
 Other: Questionnaire-based survey
The online questionnaire-based survey 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, psychological concepts and preferences.
General Type 1 Diabetes Population
A cohort consisting of the entire population of people with type 1 diabetes in Denmark not included in the Steno Tech Survey cohort (ca. 25.000 individuals).
 Other: No intervention given.
No intervention was given.


Outcome Measures
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Primary Outcome Measures :
  1. Glycated Hemoglobin A1c (HbA1c) [ Time Frame: 13 years (from 2008 (beginning of register) to present) ]
    Information on HbA1c in mmol/mol will be extracted from national registers


Secondary Outcome Measures :
  1. Other diabetes-relevant biomarkers [ Time Frame: 13 years (from 2008 (beginning of register) to present) ]
    Biomarkers included at the regular diabetes 'check-up' other than HbA1c including hemoglobin, eGFR, UACR, cholesterol total, HDL, LDL, VLDL, triglycerides and TSH will be extracted from national registers

  2. General diabetes and insulin pump-specific behavior [ Time Frame: 1 day (measured at one time point only, i.e., at the survey completion date for each participant) ]
    Measured with single items in the survey

  3. Psychological well-being [ Time Frame: 1 day (measured at one time point only, i.e., at the survey completion date for each participant) ]
    Measured with the WHO5 questionnaire scale in the survey

  4. Diabetes distress [ Time Frame: 1 day (measured at one time point only, i.e., at the survey completion date for each participant) ]
    Measured with the Type 1 Diabetes Distress (T1-DDS) questionnaire scale in the survey

  5. Hypoglycemia anxiety [ Time Frame: 1 day (measured at one time point only, i.e., at the survey completion date for each participant) ]
    Measured with the Hypoglycemia Fear Survey short-form (HFS-SF) questionnaire scale in the survey

  6. Technology-specific satisfaction [ Time Frame: 1 day (measured at one time point only, i.e., at the survey completion date for each participant) ]
    Measured with the Insulin Device Satisfaction Survey (IDSS) and the Glucose Monitoring Satisfaction Survey (GMSS) questionnaire scales in the survey

  7. Educational, time and risk preferences [ Time Frame: 1 day (measured at one time point only, i.e., at the survey completion date for each participant) ]
    Measured with single items in the survey and experimental tasks


Eligibility Criteria
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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 two groups/cohorts:

  1. Steno Tech Survey Respondents: A cohort of individuals with type 1 diabetes treated with CSII at either Steno Diabetes Center Copenhagen or Nordsjaellands Hospital Hilleroed participating in the Steno Tech Survey.
  2. General Type 1 Diabetes Population: A cohort consisting of the entire population of people with type 1 diabetes in Denmark not included in the Steno Tech Survey cohort (ca. 25.000 individuals).
Criteria

The Steno Tech Survey Repondents group:

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

The General Type 1 Population group:

  • Adult (18+ years)
  • Type 1 diabetes
Contacts and Locations
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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


Locations
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Denmark
Steno Diabetes Center Copenhagen
Gentofte, Denmark, 2820
Nordsjællands Hospital Hillerød
Hillerød, Denmark, 3400
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Nordsjaellands Hospital
  Study Documents (Full-Text)

Documents provided by Signe Schmidt, Steno Diabetes Center Copenhagen:
Study Protocol and Statistical Analysis Plan  [PDF] January 22, 2021

More Information
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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 Explore
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021
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
Keywords provided by Signe Schmidt, Steno Diabetes Center Copenhagen:
continous subcutaneous insulin infusion
clinical outcomes
psychological outcomes
 educational aspects
preferences
inequality and inequity
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