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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04311164
• Other study ID #: Steno Tech Explore
• Status: Completed
• Start date: May 15, 2020
• Est. completion date: October 15, 2020

Study information

• Verified date: January 2021
• Source: Steno Diabetes Center Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Description:

See attached protocol for a detailed description.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 770
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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.
• No intervention given.
No intervention was given.

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Copenhagen	Gentofte
Denmark	Nordsjællands Hospital Hillerød	Hillerød

Sponsors (2)

Lead Sponsor	Collaborator
Steno Diabetes Center Copenhagen	Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	13 years (from 2008 (beginning of register) to present)
Secondary	General diabetes and insulin pump-specific behavior	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)
Secondary	Psychological well-being	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)
Secondary	Diabetes distress	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)
Secondary	Hypoglycemia anxiety	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)
Secondary	Technology-specific satisfaction	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)
Secondary	Educational, time and risk preferences	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)