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

NCT ID: NCT04311164

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

770 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-15

Study Completion Date

2020-10-15

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.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Questionnaire-based survey

Intervention Type 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.

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).

No intervention given.

Intervention Type OTHER

No intervention was given.

Interventions

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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.

Intervention Type OTHER

No intervention given.

No intervention was given.

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nordsjaellands Hospital

OTHER

Sponsor Role collaborator

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Signe Schmidt

MD, PhD, Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Steno Diabetes Center Copenhagen

Gentofte Municipality, , Denmark

Site Status

Nordsjællands Hospital Hillerød

Hillerød, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 38531585 (View on PubMed)

Rytter 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.

Reference Type DERIVED
PMID: 36786049 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Steno Tech Explore

Identifier Type: -

Identifier Source: org_study_id

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