Clinical trial NCT04311164: Steno Tech Explore: A Study of Insulin Pump Users With Type 1 Diabetes
Official title: Steno Tech Explore: A Multisite Exploratory Study of People With Type 1 Diabetes on Insulin Pump Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: continous subcutaneous insulin infusion
clinical outcomes
psychological outcomes
educational aspects
preferences
inequality and inequity
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
Collaborators: name: Nordsjaellands Hospital
First posted: 2020-03-17
Enrollment: 770
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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).

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.

Detailed description: See attached protocol for a detailed description.

Eligibility 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

Primary outcomes:
measure: Glycated Hemoglobin A1c (HbA1c)
timeFrame: 13 years (from 2008 (beginning of register) to present)
Secondary outcomes:
measure: Other diabetes-relevant biomarkers
timeFrame: 13 years (from 2008 (beginning of register) to present)
measure: General diabetes and insulin pump-specific behavior
timeFrame: 1 day (measured at one time point only, i.e., at the survey completion date for each participant)
measure: Psychological well-being
timeFrame: 1 day (measured at one time point only, i.e., at the survey completion date for each participant)
measure: Diabetes distress
timeFrame: 1 day (measured at one time point only, i.e., at the survey completion date for each participant)
measure: Hypoglycemia anxiety
timeFrame: 1 day (measured at one time point only, i.e., at the survey completion date for each participant)
measure: Technology-specific satisfaction
timeFrame: 1 day (measured at one time point only, i.e., at the survey completion date for each participant)
measure: Educational, time and risk preferences
timeFrame: 1 day (measured at one time point only, i.e., at the survey completion date for each participant)
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center Copenhagen
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital Hillerød
Study officials:
References: