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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

See attached protocol for a detailed description.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Steno Diabetes Center Copenhagen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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