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| Name | Class |
|---|---|
| Nordsjaellands Hospital | OTHER |
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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.
See attached protocol for a detailed description.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire-based survey | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| General diabetes and insulin pump-specific behavior |
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The Steno Tech Survey Repondents group:
The General Type 1 Population group:
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The study population consists of two groups/cohorts:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Gentofte Municipality | 2820 | Denmark | |||
| Nordsjællands Hospital Hillerød |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38531585 | Derived | 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. | |
| 36786049 | Derived |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2021 | Jan 26, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| No intervention given. | Other | No intervention was given. |
|
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 | 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 | 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 | 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 | 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 | 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) |
| Hillerød |
| 3400 |
| Denmark |
| 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |