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 usual and use smart insulin pens and an activity tracker * Register food intake * Answer two-three questions twice a day in REDCap
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 physical activity and sleep. Participants will register food intake in the LibreLink app and respond to queries on quality of life twice daily through REDCap. At the end of the study, participants will complete the T1-DDS-28 and Health Literacy Questionnaire. Our primary objectives is to investigate the association between diabetes distress (assessed by Type 1 Diabetes Distress Scale (T1-DDS-28)) and: 1. frequency of reading CGM data, 2. frequency of low glucose alarms, 3. frequency of high glucose alarms, 4. frequency of daily between-meal insulin corrections, 5. frequency of hypoglycaemic events preceded by correction of hyperglycaemia with insulin, 6. frequency of hyperglycaemic events preceded by correction of hypoglycaemia with carbohydrates, and 7. sociodemographic and psychosocial characteristics of CGM users. Our secondary objective is to investigate the association between glycaemic metrics and the variables described above. Glycaemic metrics will be reported as CGM-metrics, including time in range defined as the percentage of time the sensor glucose is 3.9-10.0 mmol/L (70-180 mg/dL), per international consensus (ATTD, 2022)
Study Type
OBSERVATIONAL
Enrollment
500
Steno Diabetes Center Copenhagen
Herlev, Capital Region, Denmark
Copenhagen University Hospital, North Zealand - Hilleroed
Hillerød, Capital Region, Denmark
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.
Time frame: At baseline and after 14 days.
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)
Time frame: 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)
Time frame: 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)
Time frame: 14 days
Time below range level 2 (TBR2)
The percentage of time the sensor glucose is \<3.0 mmol/L (\<54 mg/dL)
Time frame: 14 days
TBR1 night
TBR 3.0-3.9 from 0000h to 0559h, level 1 night
Time frame: 14 days
TBR1 day
TBR 3.0-3.9 from 0600h to 2359h, level 1 day
Time frame: 14 days
TBR2 night
TBR \<3.0 from 0000h to 0559h, level 2 night
Time frame: 14 days
TBR2 day
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TBR \<3.0 from 0600h to 2359h, level 2 day
Time frame: 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)
Time frame: 14 days
Time above range level 2 (TAR2)
The percentage of time the sensor glucose is 13.9 mmol/L (\>250 mg/dL)
Time frame: 14 days
TAR1 night
TAR1 10.1-13.9 from 0000h to 0559h, level 1 night
Time frame: 14 days
TAR1 day
TAR1 10.1-13.9 from 0600h to 2359h, level 1 day
Time frame: 14 days
TAR2 night
TAR2 \>13.9 from 0000h to 0559h, level 1 night
Time frame: 14 days
TAR2 day
TAR2 \>13.9 from 0600h to 2359h, level 1 day
Time frame: 14 days
Coefficient of variation (CV)
Measure of glucose variability. Calculated as 100 x (SD divided by mean glucose)
Time frame: 14 days
Mean sensor glucose
Mean sensor glucose (mmol/L and mg/dL)
Time frame: 14 days
Standard deviation of mean glucose (SD)
Standard deviation of mean glucose (SD) (mmol/L and mg/dL)
Time frame: 14 days