Clinical trial NCT06453434: Diabetes Self-management With Continuous Glucose Monitoring
Official title: The Impact of Continuous Glucose Monitoring Based Self-management on Patient-Reported Outcomes and Glycaemia in Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 1 Diabetes
Keywords: Continuous Glucose Monitoring
Self-management
Diabetes Technology
Type 1 Diabetes
Diabetes Distress
Patient-reported Outcomes
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
Collaborators: name: Steno Diabetes Center Copenhagen
First posted: 2024-06-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with type 1 diabetes (n=500) on multiple daily insulin injections already using FreeStyle Libre 2.

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 usual and use smart insulin pens and an activity tracker
* Register food intake
* Answer two-three questions twice a day in REDCap

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 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)

Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 85 years.
2. Diagnosed with T1D over one year ago.
3. Actively using FreeStyle Libre 2 (\>80% sensor activity).
4. Used FreeStyle Libre 2 for over three months.
5. Uses multiple daily insulin injections.
6. Capable of providing written informed consent.
7. Willing and able to complete study procedures, including using smart caps or pens and completing questionnaires at the investigator's discretion.

Exclusion Criteria:

1. History of allergic reactions to materials or adhesives used in CGM devices.
2. 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.
3. Current use of steroids unless part of a chronic therapy plan.
4. Daily consumption of vitamin C ≥ 500 mg.

Primary outcomes:
measure: Diabetes Distress
timeFrame: At baseline and after 14 days.
Secondary outcomes:
measure: Time in range (TIR)
timeFrame: 14 days
measure: Time in tight range (TIR)
timeFrame: 14 days
measure: Time below range level 1 (TBR1)
timeFrame: 14 days
measure: Time below range level 2 (TBR2)
timeFrame: 14 days
measure: TBR1 night
timeFrame: 14 days
measure: TBR1 day
timeFrame: 14 days
measure: TBR2 night
timeFrame: 14 days
measure: TBR2 day
timeFrame: 14 days
measure: Time above range level 1 (TAR1)
timeFrame: 14 days
measure: Time above range level 2 (TAR2)
timeFrame: 14 days
measure: TAR1 night
timeFrame: 14 days
measure: TAR1 day
timeFrame: 14 days
measure: TAR2 night
timeFrame: 14 days
measure: TAR2 day
timeFrame: 14 days
measure: Coefficient of variation (CV)
timeFrame: 14 days
measure: Mean sensor glucose
timeFrame: 14 days
measure: Standard deviation of mean glucose (SD)
timeFrame: 14 days
Other outcomes:
measure: Frequency of daily CGM readings
timeFrame: 14 days
measure: Diurnal variation of daily CGM readings
timeFrame: 14 days
measure: Active sensor
timeFrame: 14 days
measure: Frequency of daily between-meal insulin corrections
timeFrame: 14 days
measure: Frequency of hypoglycaemic events preceded by correction of hyperglycaemia with insulin,
timeFrame: 14 days
measure: Frequency of hyperglycaemic events preceded by correction of hypoglycaemia with carbohydrates
timeFrame: 14 days
measure: High glucose alarm threshold
timeFrame: At baseline
measure: Low glucose alarm threshold
timeFrame: At baseline
measure: Frequency of high glucose alarms
timeFrame: 14 days
measure: Frequency of low glucose alarms
timeFrame: 14 days
measure: Low alarms enabled
timeFrame: 14 days
measure: High alarms enabled
timeFrame: 14 days
measure: Diurnal variation of high alarms
timeFrame: 14 days
measure: Diurnal variation of low alarms
timeFrame: 14 days
measure: Smart pen engagement
timeFrame: 14 days
measure: Total daily dose (TDD) of insulin
timeFrame: 14 days
measure: Total daily dose (TDD) of basal insulin
timeFrame: 14 days
measure: Total daily dose (TDD) of insulin delivered as premeal boluses
timeFrame: 14 days
measure: Total daily dose (TDD) of insulin delivered as correctional boluses
timeFrame: 14 days
measure: Percentage of TDD of insulin delivered as correctional boluses out of TDD of insulin
timeFrame: 14 days
measure: Missing basal insulin dose
timeFrame: 14 days
measure: Missing meal boluses
timeFrame: 14 days
measure: Diurnal variation of correctional boluses
timeFrame: 14 days
measure: Step count per day
timeFrame: 14 days
measure: Moderate and vigorous physical activity (MVPA)
timeFrame: 14 days
measure: Low-intensity physical activity (LPA)
timeFrame: 14 days
measure: Total physical activity (TPA) level
timeFrame: 14 days
measure: Sleep
timeFrame: 14 days
measure: Food intake
timeFrame: 14 days
measure: Food intake
timeFrame: 14 days
measure: Clarke score
timeFrame: At baseline
measure: Gold score
timeFrame: At baseline
measure: Hilleroed method
timeFrame: At baseline
measure: Glucose Monitoring Satisfaction Survey (GMSS)
timeFrame: At baseline
measure: Perceived Competence in Diabetes (PCD)
timeFrame: At baseline
measure: Diabetes Treatment Satisfaction Questionnaire status (DTSQs)
timeFrame: At baseline
measure: Hypoglycaemia Fear Survey-II Short Form (HFS-SF)
timeFrame: At baseline
measure: The Danish Health Literacy Questionnaire (HLQ)
timeFrame: At baseline
measure: Based on Saltin-Grimby Physical Activity Level Scale (SGPALS)
timeFrame: At baseline
measure: Well-Being Index (WHO-5)
timeFrame: At baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At baseline
measure: Type D scale (DS-14)
timeFrame: At baseline
measure: VAS-A
timeFrame: Each morning and each evening during the study period
measure: EQ-VAS
timeFrame: Each morning during the study period
Locations:
city: Herlev
country: Denmark
facility: Steno Diabetes Center Copenhagen
state: Region Hovedstaden
city: Hillerød
country: Denmark
facility: Copenhagen University Hospital, North Zealand - Hilleroed
state: Region Hovedstaden
Study officials:
affiliation: Copenhagen University Hospital, North Zealand - Hollered
name: Ulrik Pedersen-Bjergaard, Professor
role: PRINCIPAL_INVESTIGATOR
References: