Diabetes Mellitus, Type 1
Conditions
Keywords
continous subcutaneous insulin infusion, clinical outcomes, psychological outcomes, educational aspects, preferences, inequality and inequity
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.
Interventions
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.
OTHERNo intervention given.
No intervention was given.
Sponsors
Nordsjaellands Hospital
Steno Diabetes Center Copenhagen
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Denmark
Outcome results
None listed