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NCT Number: NCT06453434

Diabetes Self-management With Continuous Glucose Monitoring

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Steno Diabetes Center Copenhagen, Herlev, Capital Region, Denmark

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About this study

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:

  • frequency of reading CGM data,
  • frequency of low glucose alarms,
  • frequency of high glucose alarms,
  • frequency of daily between-meal insulin corrections,
  • frequency of hypoglycaemic events preceded by correction of hyperglycaemia with insulin,
  • frequency of hyperglycaemic events preceded by correction of hypoglycaemia with carbohydrates, and
  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Diabetes Distress

    Time frame: At baseline and after 14 days.

    Type 1 Diabetes Distress Scale (T1-DDS-28)) Score. Likert scale. Score from 1 to 5. Higher scores indicate higher grade of diabetes distress.

Secondary outcomes

  1. Time in range (TIR)

    Time frame: 14 days

    Time in range defined as the percentage of time the sensor glucose is 3.9-10.0 mmol/L (70-180 mg/dL)

  2. Time in tight range (TIR)

    Time frame: 14 days

    The percentage of time the sensor glucose is 3.9-7.8 mmol/L (70-140 mg/dL)

  3. Time below range level 1 (TBR1)

    Time frame: 14 days

    The percentage of time the sensor glucose is 3.0-3.9 mmol/L (54-70 mg/dL)

  4. Time below range level 2 (TBR2)

    Time frame: 14 days

    The percentage of time the sensor glucose is <3.0 mmol/L (<54 mg/dL)

  5. TBR1 night

    Time frame: 14 days

    TBR 3.0-3.9 from 0000h to 0559h, level 1 night

  6. TBR1 day

    Time frame: 14 days

    TBR 3.0-3.9 from 0600h to 2359h, level 1 day

  7. TBR2 night

    Time frame: 14 days

    TBR <3.0 from 0000h to 0559h, level 2 night

  8. TBR2 day

    Time frame: 14 days

    TBR <3.0 from 0600h to 2359h, level 2 day

  9. Time above range level 1 (TAR1)

    Time frame: 14 days

    The percentage of time the sensor glucose is 10.1-13.9 mmol/L (181-250 mg/dL)

  10. Time above range level 2 (TAR2)

    Time frame: 14 days

    The percentage of time the sensor glucose is 13.9 mmol/L (>250 mg/dL)

  11. TAR1 night

    Time frame: 14 days

    TAR1 10.1-13.9 from 0000h to 0559h, level 1 night

  12. TAR1 day

    Time frame: 14 days

    TAR1 10.1-13.9 from 0600h to 2359h, level 1 day

  13. TAR2 night

    Time frame: 14 days

    TAR2 >13.9 from 0000h to 0559h, level 1 night

  14. TAR2 day

    Time frame: 14 days

    TAR2 >13.9 from 0600h to 2359h, level 1 day

  15. Coefficient of variation (CV)

    Time frame: 14 days

    Measure of glucose variability. Calculated as 100 x (SD divided by mean glucose)

  16. Mean sensor glucose

    Time frame: 14 days

    Mean sensor glucose (mmol/L and mg/dL)

  17. Standard deviation of mean glucose (SD)

    Time frame: 14 days

    Standard deviation of mean glucose (SD) (mmol/L and mg/dL)

Other outcomes

  1. Frequency of daily CGM readings

    Time frame: 14 days

    How many times the participants open the LibreView app to assess their CGM data during the day

  2. Diurnal variation of daily CGM readings

    Time frame: 14 days

    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)

  3. Active sensor

    Time frame: 14 days

    Percentage of sensor data obtained

  4. Frequency of daily between-meal insulin corrections

    Time frame: 14 days

    How many times the participants take between-meal insulin corrections daily

  5. Frequency of hypoglycaemic events preceded by correction of hyperglycaemia with insulin,

    Time frame: 14 days

    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

  6. Frequency of hyperglycaemic events preceded by correction of hypoglycaemia with carbohydrates

    Time frame: 14 days

    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

  7. High glucose alarm threshold

    Time frame: At baseline

    Mean/median alarm threshold level at baseline

  8. Low glucose alarm threshold

    Time frame: At baseline

    Mean/median alarm threshold level at baseline

  9. Frequency of high glucose alarms

    Time frame: 14 days

    Number of high glucose alarms during the study

  10. Frequency of low glucose alarms

    Time frame: 14 days

    Number of low glucose alarms during the study

  11. Low alarms enabled

    Time frame: 14 days

    Percentage of time low alarms are activated

  12. High alarms enabled

    Time frame: 14 days

    Percentage of time high alarms are activated

  13. Diurnal variation of high alarms

    Time frame: 14 days

    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. Diurnal variation of low alarms

    Time frame: 14 days

    Numbers in the morning (06.00-11.59), afternoon (12.00-17.59), evening (18.00-23.59) and night (00.00-05.59)

  15. Smart pen engagement

    Time frame: 14 days

    Number of days with data uploads during the study period

  16. Total daily dose (TDD) of insulin

    Time frame: 14 days

    Mean of the study period. Recorded by smartpens.

  17. Total daily dose (TDD) of basal insulin

    Time frame: 14 days

    Mean of the study period. Recorded by smartpens.

  18. Total daily dose (TDD) of insulin delivered as premeal boluses

    Time frame: 14 days

    Mean of the study period. Recorded by smartpens.

  19. Total daily dose (TDD) of insulin delivered as correctional boluses

    Time frame: 14 days

    Mean of the study period. Recorded by smartpens.

  20. Percentage of TDD of insulin delivered as correctional boluses out of TDD of insulin

    Time frame: 14 days

    Percentage

  21. Missing basal insulin dose

    Time frame: 14 days

    ≥ 40 hours between basal insulin injections

  22. Missing meal boluses

    Time frame: 14 days

    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.

  23. Diurnal variation of correctional boluses

    Time frame: 14 days

    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

  24. Step count per day

    Time frame: 14 days

    From activity sensor

  25. Moderate and vigorous physical activity (MVPA)

    Time frame: 14 days

    From activity sensor. Time spent on moderate and vigorous physical activity (MVPA)

  26. Low-intensity physical activity (LPA)

    Time frame: 14 days

    From activity sensor. Time spent on low-intensity physical activity (LPA) time

  27. Total physical activity (TPA) level

    Time frame: 14 days

    From activity sensor. TPA measured in counts per minute

  28. Sleep

    Time frame: 14 days

    From activity sensor. Sleep hours per night

  29. Food intake

    Time frame: 14 days

    Database which contains food intake data (amount of food in carbohydrates) retrieved from the diary app (LibreLink).

  30. Food intake

    Time frame: 14 days

    Database which contains food intake data (timing of food intake) retrieved from the diary app (LibreLink).

  31. Clarke score

    Time frame: At baseline

    Patient-reported outcome regarding awareness of hypoglycemia.

  32. Gold score

    Time frame: At baseline

    Patient-reported outcome regarding awareness of hypoglycemia.

  33. Hilleroed method

    Time frame: At baseline

    Patient-reported outcome regarding awareness of hypoglycemia.

  34. Glucose Monitoring Satisfaction Survey (GMSS)

    Time frame: At baseline

    Patient-reported outcome regarding CGM satisfaction

  35. Perceived Competence in Diabetes (PCD)

    Time frame: At baseline

    Patient-reported outcome regarding diabetes self-management

  36. Diabetes Treatment Satisfaction Questionnaire status (DTSQs)

    Time frame: At baseline

    Patient-reported outcome regarding diabetes treatment satisfaction

  37. Hypoglycaemia Fear Survey-II Short Form (HFS-SF)

    Time frame: At baseline

    Patient-reported outcome regarding fear of hypoglycemia

  38. The Danish Health Literacy Questionnaire (HLQ)

    Time frame: At baseline

    Patient-reported outcome regarding health literacy

  39. Based on Saltin-Grimby Physical Activity Level Scale (SGPALS)

    Time frame: At baseline

    Patient-reported outcome regarding physical activity

  40. Well-Being Index (WHO-5)

    Time frame: At baseline

    Patient-reported outcome regarding psychological well-being

  41. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: At baseline

    Patient-reported outcome regarding sleep quality

  42. Type D scale (DS-14)

    Time frame: At baseline

    Patient-reported outcome regarding type D personality trait

  43. VAS-A

    Time frame: Each morning and each evening during the study period

    Patient-reported outcome regarding anxiety

  44. EQ-VAS

    Time frame: Each morning during the study period

    Patient-reported outcome regarding overall health

Study contacts

Contact information is provided by the study sponsor or research team.

Mette J Nitschke, PhD Student

CONTACT

[email protected]

+45 41 24 72 16

Ulrik Pedersen-Bjergaard, Professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Collaborators

  • Steno Diabetes Center Copenhagen

Registry information

Official study title

The Impact of Continuous Glucose Monitoring Based Self-management on Patient-Reported Outcomes and Glycaemia in Type 1 Diabetes

Acronym: DIASELF

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 11, 2024
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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