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NCT Number: NCT04311164

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Steno Diabetes Center Copenhagen, Gentofte Municipality, Denmark

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About this study

See attached protocol for a detailed description.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire-based survey

Other

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.

No intervention given.

Other

No intervention was given.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Collaborators

  • Nordsjaellands Hospital

Registry information

Official study title

Steno Tech Explore: A Multisite Exploratory Study of People With Type 1 Diabetes on Insulin Pump Therapy

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 17, 2020
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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