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

January 29, 2021 updated by: Signe Schmidt, Steno Diabetes Center Copenhagen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See attached protocol for a detailed description.

Study Type

Observational

Enrollment (Actual)

770

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Gentofte, Denmark, 2820
        • Steno Diabetes Center Copenhagen
      • Hillerød, Denmark, 3400
        • Nordsjællands Hospital Hillerød

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: 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.
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).
Other: No intervention given.
No intervention was given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
13 years (from 2008 (beginning of register) to present)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
13 years (from 2008 (beginning of register) to present)
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
1 day (measured at one time point only, i.e., at the survey completion date for each participant)
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
1 day (measured at one time point only, i.e., at the survey completion date for each participant)
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
1 day (measured at one time point only, i.e., at the survey completion date for each participant)
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
1 day (measured at one time point only, i.e., at the survey completion date for each participant)
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
1 day (measured at one time point only, i.e., at the survey completion date for each participant)
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
1 day (measured at one time point only, i.e., at the survey completion date for each participant)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steno Diabetes Center Copenhagen

Collaborators

Nordsjaellands Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2020

Primary Completion (Actual)

October 15, 2020

Study Completion (Actual)

October 15, 2020

Study Registration Dates

First Submitted

March 11, 2020

First Submitted That Met QC Criteria

March 14, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 29, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Steno Tech Explore

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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