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

Study Overview
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Brief Summary
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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.

Detailed Description
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See attached protocol for a detailed description.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Other: Questionnaire-based survey
* Other: No intervention given.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Steno Tech Survey Respondents<br>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<br>* 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.<br>|
| General Type 1 Diabetes Population<br>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.<br>* No intervention was given.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated Hemoglobin A1c (HbA1c) | Information on HbA1c in mmol/mol will be extracted from national registers | 13 years (from 2008 (beginning of register) to present) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other diabetes-relevant biomarkers | 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 | 13 years (from 2008 (beginning of register) to present) | 
| General diabetes and insulin pump-specific behavior | Measured with single items in the survey | 1 day (measured at one time point only, i.e., at the survey completion date for each participant) | 
| Psychological well-being | Measured with the WHO5 questionnaire scale in the survey | 1 day (measured at one time point only, i.e., at the survey completion date for each participant) | 
| Diabetes distress | Measured with the Type 1 Diabetes Distress (T1-DDS) questionnaire scale in the survey | 1 day (measured at one time point only, i.e., at the survey completion date for each participant) | 
| Hypoglycemia anxiety | Measured with the Hypoglycemia Fear Survey short-form (HFS-SF) questionnaire scale in the survey | 1 day (measured at one time point only, i.e., at the survey completion date for each participant) | 
| Technology-specific satisfaction | Measured with the Insulin Device Satisfaction Survey (IDSS) and the Glucose Monitoring Satisfaction Survey (GMSS) questionnaire scales in the survey | 1 day (measured at one time point only, i.e., at the survey completion date for each participant) | 
| Educational, time and risk preferences | Measured with single items in the survey and experimental tasks | 1 day (measured at one time point only, i.e., at the survey completion date for each participant) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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continous subcutaneous insulin infusion, clinical outcomes, psychological outcomes, educational aspects, preferences, inequality and inequity