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| Name | Class |
|---|---|
| Steno Diabetes Center Copenhagen | OTHER |
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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:
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:
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)
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| 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. |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of daily CGM readings | How many times the participants open the LibreView app to assess their CGM data during the day | 14 days |
| Diurnal variation of daily CGM readings | Numbers in the morning (06.00-11.59), afternoon (12.00-17.59), in the evening (18.00-23.59) and in the night (00.00-05.59) |
Inclusion Criteria:
Exclusion Criteria:
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Adults with type 1 diabetes (n=500) on multiple daily insulin injections already using FreeStyle Libre 2.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mette J Nitschke, PhD Student | Contact | +45 41 24 72 16 | mette.juul.nitschke@regionh.dk | |
| Ulrik Pedersen-Bjergaard, Professor | Contact | ulrik.pedersen-bjergaard@outlook.dk |
| Name | Affiliation | Role |
|---|---|---|
| Ulrik Pedersen-Bjergaard, Professor | Copenhagen University Hospital, North Zealand - Hollered | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Herlev | Capital Region | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40897486 | Derived | Nitschke MJ, Demir C, Brosen JMB, Tapager IW, Norgaard K, Kristensen PL, Pedersen-Bjergaard U. Diabetes self-management observational study investigating how CGM use impacts diabetes distress, glycaemia and functions as a technological substitute for hypoglycaemia awareness: a study protocol. BMJ Open. 2025 Sep 2;15(9):e103469. doi: 10.1136/bmjopen-2025-103469. |
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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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| 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 |
| 14 days |
| Active sensor | Percentage of sensor data obtained | 14 days |
| Frequency of daily between-meal insulin corrections | How many times the participants take between-meal insulin corrections daily | 14 days |
| Frequency of hypoglycaemic events preceded by correction of hyperglycaemia with insulin, | For each hypoglycaemic event (defined as a glucose level ≥ 10 mmol/L (180 mg/dL)) a cause of the event will be interpreted based on 4-hours data and classified as either preceded by 1) premeal-insulin, 2) insulin correction of hyperglycemia or 3) physical activity | 14 days |
| Frequency of hyperglycaemic events preceded by correction of hypoglycaemia with carbohydrates | For each hyperglycaemic event (defined as glucose level ≥ 10 mmol/L (180 mg/dL) ≥ 15 consecutive minutes) a cause of the event will be interpreted based on 4-hours data and classified as either preceded by 1) carbohydrate intake without premeal insulin, 2) carbohydrate intake with premeal insulin, or 3) correction of hypoglycaemia with carbohydrate | 14 days |
| High glucose alarm threshold | Mean/median alarm threshold level at baseline | At baseline |
| Low glucose alarm threshold | Mean/median alarm threshold level at baseline | At baseline |
| Frequency of high glucose alarms | Number of high glucose alarms during the study | 14 days |
| Frequency of low glucose alarms | Number of low glucose alarms during the study | 14 days |
| Low alarms enabled | Percentage of time low alarms are activated | 14 days |
| High alarms enabled | Percentage of time high alarms are activated | 14 days |
| Diurnal variation of high alarms | Numbers in the morning (06.00-11.59), afternoon (12.00-17.59), evening (18.00-23.59) and night (00.00-05.59) | 14 days |
| Diurnal variation of low alarms | Numbers in the morning (06.00-11.59), afternoon (12.00-17.59), evening (18.00-23.59) and night (00.00-05.59) | 14 days |
| Smart pen engagement | Number of days with data uploads during the study period | 14 days |
| Total daily dose (TDD) of insulin | Mean of the study period. Recorded by smartpens. | 14 days |
| Total daily dose (TDD) of basal insulin | Mean of the study period. Recorded by smartpens. | 14 days |
| Total daily dose (TDD) of insulin delivered as premeal boluses | Mean of the study period. Recorded by smartpens. | 14 days |
| Total daily dose (TDD) of insulin delivered as correctional boluses | Mean of the study period. Recorded by smartpens. | 14 days |
| Percentage of TDD of insulin delivered as correctional boluses out of TDD of insulin | Percentage | 14 days |
| Missing basal insulin dose | ≥ 40 hours between basal insulin injections | 14 days |
| Missing meal boluses | No bolus injection within 15 minutes before and 60 minutes after the start of a meal. Meals identified using a food diary/CGM signal by using the GRID algorithm. | 14 days |
| Diurnal variation of correctional boluses | Numbers in the morning (06.00-11.59), afternoon (12.00-17.59), in the evening (18.00-23.59) and in the night (00.00-05.59), respectively | 14 days |
| Step count per day | From activity sensor | 14 days |
| Moderate and vigorous physical activity (MVPA) | From activity sensor. Time spent on moderate and vigorous physical activity (MVPA) | 14 days |
| Low-intensity physical activity (LPA) | From activity sensor. Time spent on low-intensity physical activity (LPA) time | 14 days |
| Total physical activity (TPA) level | From activity sensor. TPA measured in counts per minute | 14 days |
| Sleep | From activity sensor. Sleep hours per night | 14 days |
| Food intake | Database which contains food intake data (amount of food in carbohydrates) retrieved from the diary app (LibreLink). | 14 days |
| Food intake | Database which contains food intake data (timing of food intake) retrieved from the diary app (LibreLink). | 14 days |
| Clarke score | Patient-reported outcome regarding awareness of hypoglycemia. | At baseline |
| Gold score | Patient-reported outcome regarding awareness of hypoglycemia. | At baseline |
| Hilleroed method | Patient-reported outcome regarding awareness of hypoglycemia. | At baseline |
| Glucose Monitoring Satisfaction Survey (GMSS) | Patient-reported outcome regarding CGM satisfaction | At baseline |
| Perceived Competence in Diabetes (PCD) | Patient-reported outcome regarding diabetes self-management | At baseline |
| Diabetes Treatment Satisfaction Questionnaire status (DTSQs) | Patient-reported outcome regarding diabetes treatment satisfaction | At baseline |
| Hypoglycaemia Fear Survey-II Short Form (HFS-SF) | Patient-reported outcome regarding fear of hypoglycemia | At baseline |
| The Danish Health Literacy Questionnaire (HLQ) | Patient-reported outcome regarding health literacy | At baseline |
| Based on Saltin-Grimby Physical Activity Level Scale (SGPALS) | Patient-reported outcome regarding physical activity | At baseline |
| Well-Being Index (WHO-5) | Patient-reported outcome regarding psychological well-being | At baseline |
| Pittsburgh Sleep Quality Index (PSQI) | Patient-reported outcome regarding sleep quality | At baseline |
| Type D scale (DS-14) | Patient-reported outcome regarding type D personality trait | At baseline |
| VAS-A | Patient-reported outcome regarding anxiety | Each morning and each evening during the study period |
| EQ-VAS | Patient-reported outcome regarding overall health | Each morning during the study period |
| Copenhagen University Hospital, North Zealand - Hilleroed | Hillerød | Capital Region | 3400 | Denmark |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |