Steno Tech Explore: A Study of Insulin Pump Users With Type 1 Diabetes
Steno Tech Explore: A Multisite Exploratory Study of People With Type 1 Diabetes on Insulin Pump Therapy
1 other identifier
observational
770
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2020
CompletedFirst Posted
Study publicly available on registry
March 17, 2020
CompletedStudy Start
First participant enrolled
May 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2020
CompletedFebruary 1, 2021
January 1, 2021
5 months
March 11, 2020
January 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Other diabetes-relevant biomarkers
13 years (from 2008 (beginning of register) to present)
General diabetes and insulin pump-specific behavior
1 day (measured at one time point only, i.e., at the survey completion date for each participant)
Psychological well-being
1 day (measured at one time point only, i.e., at the survey completion date for each participant)
Diabetes distress
1 day (measured at one time point only, i.e., at the survey completion date for each participant)
Hypoglycemia anxiety
1 day (measured at one time point only, i.e., at the survey completion date for each participant)
- +2 more secondary outcomes
Study Arms (2)
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.
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).
Interventions
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.
Eligibility Criteria
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).
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Steno Diabetes Center Copenhagenlead
- Nordsjaellands Hospitalcollaborator
Study Sites (2)
Steno Diabetes Center Copenhagen
Gentofte Municipality, 2820, Denmark
Nordsjællands Hospital Hillerød
Hillerød, 3400, Denmark
Related Publications (2)
Lorenzen JT, Madsen KP, Cleal B, Joensen LE, Norgaard K, Pedersen-Bjergaard U, Schmidt S, Rytter K, Willaing I. Associations between use of diabetes technology and diabetes distress: a Danish cross-sectional survey of adults with type 1 diabetes. BMJ Open. 2024 Mar 25;14(3):e080053. doi: 10.1136/bmjopen-2023-080053.
PMID: 38531585DERIVEDRytter K, Madsen KP, Andersen HU, Hommel E, Pedersen-Bjergaard U, Schmidt S, Norgaard K. Associations between insulin pump self-management and HbA1c in type 1 diabetes. Diabet Med. 2023 Jun;40(6):e15068. doi: 10.1111/dme.15068. Epub 2023 Feb 25.
PMID: 36786049DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Researcher
Study Record Dates
First Submitted
March 11, 2020
First Posted
March 17, 2020
Study Start
May 15, 2020
Primary Completion
October 15, 2020
Study Completion
October 15, 2020
Last Updated
February 1, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share