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Diabetes Mellitus, Type 1NCT04311164

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

An observational study of Diabetes Mellitus, Type 1, run by Steno Diabetes Center Copenhagen at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Questionnaire-based survey
How many people
770 participants
Where
2 sitesDenmark
Study dates
15 May 2020to 15 Oct 2020
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

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

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Steno Diabetes Center Copenhagen

    Gentofte Municipality, 2820

  • Nordsjællands Hospital Hillerød

    Hillerød, 3400

Other trials in Denmark

About this study

Official title: 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.

Read the detailed description

See attached protocol for a detailed description.

Being tested
Questionnaire-based survey, No intervention given.
Keywords
continous subcutaneous insulin infusion, clinical outcomes, psychological outcomes, educational aspects, preferences, inequality and inequity
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Questionnaire-based surveyOther

    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.

  • No intervention given.Other

    No intervention was given.

Study groups in NCT04311164
Study groupRoleWhat they receive
Steno Tech Survey RespondentsA cohort of individuals with type 1 diabetes treated with CSII at either SDCC or NOH participating in the Steno Tech Survey.
Receives: Other: Questionnaire-based survey
General Type 1 Diabetes PopulationA 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).
Receives: Other: No intervention given.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycated Hemoglobin A1c (HbA1c)

    Information on HbA1c in mmol/mol will be extracted from national registers

    Measured: 13 years (from 2008 (beginning of register) to present)

Secondary outcomes (7)

  1. Other diabetes-relevant biomarkers

    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

    Measured: 13 years (from 2008 (beginning of register) to present)

  2. General diabetes and insulin pump-specific behavior

    Measured with single items in the survey

    Measured: 1 day (measured at one time point only, i.e., at the survey completion date for each participant)

  3. Psychological well-being

    Measured with the WHO5 questionnaire scale in the survey

    Measured: 1 day (measured at one time point only, i.e., at the survey completion date for each participant)

  4. Diabetes distress

    Measured with the Type 1 Diabetes Distress (T1-DDS) questionnaire scale in the survey

    Measured: 1 day (measured at one time point only, i.e., at the survey completion date for each participant)

  5. Hypoglycemia anxiety

    Measured with the Hypoglycemia Fear Survey short-form (HFS-SF) questionnaire scale in the survey

    Measured: 1 day (measured at one time point only, i.e., at the survey completion date for each participant)

  6. Technology-specific satisfaction

    Measured with the Insulin Device Satisfaction Survey (IDSS) and the Glucose Monitoring Satisfaction Survey (GMSS) questionnaire scales in the survey

    Measured: 1 day (measured at one time point only, i.e., at the survey completion date for each participant)

  7. Educational, time and risk preferences

    Measured with single items in the survey and experimental tasks

    Measured: 1 day (measured at one time point only, i.e., at the survey completion date for each participant)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2020
  2. Study start15 May 2020
  3. Primary completion15 Oct 2020
  4. Study completion15 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
770 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT04311164
Sponsor's protocol ID
Steno Tech Explore
Status last verified
Jan 2021
First submitted
11 Mar 2020
Last updated
1 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38531585

  • 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.

    PubMed 36786049

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 1, run by Steno Diabetes Center Copenhagen at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycated Hemoglobin A1c (HbA1c) (time frame: 13 years (from 2008 (beginning of register) to present)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04311164, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.

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