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

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Other: Questionnaire-based survey; Other: No intervention given.

• Registration Number: NCT04311164
• Lead Sponsor: Steno Diabetes Center Copenhagen

Brief 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.

Detailed Description

See attached protocol for a detailed description.

Study Timeline

• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-14
• Study First Posted: 2020-03-17
• Study Start: 2020-05-15
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 770

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Steno Tech Survey Respondents	Questionnaire-based survey	A cohort of individuals with type 1 diabetes treated with CSII at either SDCC or NOH participating in the Steno Tech Survey.
General Type 1 Diabetes Population	No intervention given.	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).

Primary Outcome Measures

Name	Time	Method
Glycated Hemoglobin A1c (HbA1c)	13 years (from 2008 (beginning of register) to present)	Information on HbA1c in mmol/mol will be extracted from national registers

Secondary Outcome Measures

Name	Time	Method
General diabetes and insulin pump-specific behavior	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
Diabetes distress	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
Hypoglycemia anxiety	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
Technology-specific satisfaction	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
Other diabetes-relevant biomarkers	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
Psychological well-being	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
Educational, time and risk preferences	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

Trial Locations

Locations (2)

Steno Diabetes Center Copenhagen; 🇩🇰 Gentofte, Denmark

Nordsjællands Hospital Hillerød; 🇩🇰 Hillerød, Denmark