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Clinical Trial NCT06453434 (DIASELF) for Type 1 Diabetes is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Diabetes Self-management With Continuous Glucose Monitoring (DIASELF) 500 Observational
Clinical Trial NCT06453434 (DIASELF) is an observational study for Type 1 Diabetes and is currently not yet recruiting. Enrollment is planned to begin on 1 July 2024 and continue until the study accrues 500 participants. Led by Nordsjaellands Hospital, this study is expected to complete by 1 August 2026. The latest data from ClinicalTrials.gov was last updated on 11 June 2024.
Brief Summary
The overall goal of this observational study is to investigate the interaction between people with type 1 diabetes and continuous glucose monitoring (CGM) and the impact of this interaction on quality of life, particularly the level of diabetes distress, and glycaemic metrics.
Participants will:
- Visit the clinic twice with a 14-day interval
- Fill out a survey before the first and at the last visit
- Use CGM as u...
Detailed Description
A two-centre observational study conducted in Denmark, including adults with type 1 diabetes (n=500) on multiple daily injections already using FreeStyle Libre 2.
Upon recruitment, participants will complete a survey of 11 validated questionnaires, including T1-DDS-28. For 14 days, participants will continue regular CGM use, smart insulin pens will record real-time insulin dosage, and an activity sensor will monitor...
Show MoreOfficial Title
The Impact of Continuous Glucose Monitoring Based Self-management on Patient-Reported Outcomes and Glycaemia in Type 1 Diabetes
Conditions
Type 1 DiabetesPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- DIASELF
- U1111-1306-6133
NCT ID Number
Start Date (Actual)
2024-07-01
Last Update Posted
2024-06-11
Completion Date (Estimated)
2026-08
Enrollment (Estimated)
500
Study Type
Observational
Status
Not yet recruiting
Keywords
Continuous Glucose Monitoring
Self-management
Diabetes Technology
Type 1 Diabetes
Diabetes Distress
Patient-reported Outcomes
Self-management
Diabetes Technology
Type 1 Diabetes
Diabetes Distress
Patient-reported Outcomes
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Diabetes Distress | Type 1 Diabetes Distress Scale (T1-DDS-28)) Score. Likert scale. Score from 1 to 5. Higher scores indicate higher grade of diabetes distress. | At baseline and after 14 days. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Time in range (TIR) | Time in range defined as the percentage of time the sensor glucose is 3.9-10.0 mmol/L (70-180 mg/dL) | 14 days |
Time in tight range (TIR) | The percentage of time the sensor glucose is 3.9-7.8 mmol/L (70-140 mg/dL) | 14 days |
Time below range level 1 (TBR1) | The percentage of time the sensor glucose is 3.0-3.9 mmol/L (54-70 mg/dL) | 14 days |
Time below range level 2 (TBR2) | The percentage of time the sensor glucose is \<3.0 mmol/L (\<54 mg/dL) | 14 days |
TBR1 night | TBR 3.0-3.9 from 0000h to 0559h, level 1 night | 14 days |
TBR1 day | TBR 3.0-3.9 from 0600h to 2359h, level 1 day | 14 days |
TBR2 night | TBR \<3.0 from 0000h to 0559h, level 2 night | 14 days |
TBR2 day | TBR \<3.0 from 0600h to 2359h, level 2 day | 14 days |
Time above range level 1 (TAR1) | The percentage of time the sensor glucose is 10.1-13.9 mmol/L (181-250 mg/dL) | 14 days |
Time above range level 2 (TAR2) | The percentage of time the sensor glucose is 13.9 mmol/L (\>250 mg/dL) | 14 days |
TAR1 night | TAR1 10.1-13.9 from 0000h to 0559h, level 1 night | 14 days |
TAR1 day | TAR1 10.1-13.9 from 0600h to 2359h, level 1 day | 14 days |
TAR2 night | TAR2 \>13.9 from 0000h to 0559h, level 1 night | 14 days |
TAR2 day | TAR2 \>13.9 from 0600h to 2359h, level 1 day | 14 days |
Coefficient of variation (CV) | Measure of glucose variability. Calculated as 100 x (SD divided by mean glucose) | 14 days |
Mean sensor glucose | Mean sensor glucose (mmol/L and mg/dL) | 14 days |
Standard deviation of mean glucose (SD) | Standard deviation of mean glucose (SD) (mmol/L and mg/dL) | 14 days |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Age between 18 and 85 years.
- Diagnosed with T1D over one year ago.
- Actively using FreeStyle Libre 2 (>80% sensor activity).
- Used FreeStyle Libre 2 for over three months.
- Uses multiple daily insulin injections.
- Capable of providing written informed consent.
- Willing and able to complete study procedures, including using smart caps or pens and completing questionnaires at the investigator's discretion.
- History of allergic reactions to materials or adhesives used in CGM devices.
- Presence of severe cognitive or psychiatric conditions that could hinder the effective use of CGM or smart caps or pens - at the investigator's discretion.
- Current use of steroids unless part of a chronic therapy plan.
- Daily consumption of vitamin C ≥ 500 mg.
Nordsjaellands HospitalSteno Diabetes Center CopenhagenStudy Central Contact
Contact: Mette J Nitschke, PhD Student, +45 41 24 72 16, [email protected]
Contact: Ulrik Pedersen-Bjergaard, Professor, [email protected]
2 Study Locations in 1 Countries
Capital Region
Steno Diabetes Center Copenhagen, Herlev, Capital Region, 2730, Denmark
Kirsten Nørgaard, Professor, Contact, +45 27 13 10 11, [email protected]
Kirsten Nørgaard, Professor, Principal Investigator
Copenhagen University Hospital, North Zealand - Hilleroed, Hillerød, Capital Region, 3400, Denmark
Mette J Nitschke, PhD student, Contact, +45 41 24 72 16, [email protected]
Mette J Nitschke, PhD student, Sub-Investigator
Ulrik Pedersen-Bjergaard, Professor, Principal Investigator