Type 1 DiabetesDIASELFNCT06453434
Diabetes Self-management With Continuous Glucose Monitoring
An observational study of Type 1 Diabetes, run by Nordsjaellands Hospital at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 500 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jul 2024to Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with type 1 diabetes (n=500) on multiple daily insulin injections already using FreeStyle Libre 2.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Ulrik Pedersen-Bjergaard, Professor contact
Denmark2 sites
Steno Diabetes Center Copenhagen
Herlev, Capital Region, 2730
Kirsten Nørgaard, Professor, +45 27 13 10 11, kirsten.noergaard@regionh.dk
Kirsten Nørgaard, Professor
Copenhagen University Hospital, North Zealand - Hilleroed
Hillerød, Capital Region, 3400
Mette J Nitschke, PhD student, +45 41 24 72 16, mette.juul.nitschke@regionh.dk
Mette J Nitschke, PhD student
About this study
Official title: The Impact of Continuous Glucose Monitoring Based Self-management on Patient-Reported Outcomes and Glycaemia in Type 1 Diabetes
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
Read the 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:
- 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)
- Conditions
- Type 1 Diabetes
- Keywords
- Continuous Glucose Monitoring, Self-management, Diabetes Technology, Type 1 Diabetes, Diabetes Distress, Patient-reported Outcomes
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and after 14 days.
Secondary outcomes (17)
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)
Measured: 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)
Measured: 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)
Measured: 14 days
Time below range level 2 (TBR2)
The percentage of time the sensor glucose is <3.0 mmol/L (<54 mg/dL)
Measured: 14 days
TBR1 night
TBR 3.0-3.9 from 0000h to 0559h, level 1 night
Measured: 14 days
TBR1 day
TBR 3.0-3.9 from 0600h to 2359h, level 1 day
Measured: 14 days
TBR2 night
TBR <3.0 from 0000h to 0559h, level 2 night
Measured: 14 days
TBR2 day
TBR <3.0 from 0600h to 2359h, level 2 day
Measured: 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)
Measured: 14 days
Time above range level 2 (TAR2)
The percentage of time the sensor glucose is 13.9 mmol/L (>250 mg/dL)
Measured: 14 days
TAR1 night
TAR1 10.1-13.9 from 0000h to 0559h, level 1 night
Measured: 14 days
TAR1 day
TAR1 10.1-13.9 from 0600h to 2359h, level 1 day
Measured: 14 days
TAR2 night
TAR2 >13.9 from 0000h to 0559h, level 1 night
Measured: 14 days
TAR2 day
TAR2 >13.9 from 0600h to 2359h, level 1 day
Measured: 14 days
Coefficient of variation (CV)
Measure of glucose variability. Calculated as 100 x (SD divided by mean glucose)
Measured: 14 days
Mean sensor glucose
Mean sensor glucose (mmol/L and mg/dL)
Measured: 14 days
Standard deviation of mean glucose (SD)
Standard deviation of mean glucose (SD) (mmol/L and mg/dL)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen
- Responsible party
- Sponsor
- Investigators
- Ulrik Pedersen-Bjergaard, Professor, Principal investigator, Copenhagen University Hospital, North Zealand - Hollered
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453434
- Sponsor's protocol ID
- U1111-1306-6133
- Acronym
- DIASELF
- Status last verified
- Apr 2024
- First submitted
- 30 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40897486
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Continuous Glucose Monitoring Based Self-management on Patient-Reported Outcomes and Glycaemia in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06453434
- Acronym / sponsor ID
- DIASELF / U1111-1306-6133
- Conditions
- Type 1 Diabetes
- Keywords
- Continuous Glucose Monitoring, Self-management, Diabetes Technology, Type 1 Diabetes, Diabetes Distress, Patient-reported Outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with type 1 diabetes (n=500) on multiple daily insulin injections already using FreeStyle Libre 2.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
17 secondary outcomes
Time in range (TIR)
Time frame: 14 days
Time in tight range (TIR)
Time frame: 14 days
Time below range level 1 (TBR1)
Time frame: 14 days
Time below range level 2 (TBR2)
Time frame: 14 days
TBR1 night
Time frame: 14 days
TBR1 day
Time frame: 14 days
TBR2 night
Time frame: 14 days
TBR2 day
Time frame: 14 days
Time above range level 1 (TAR1)
Time frame: 14 days
Time above range level 2 (TAR2)
Time frame: 14 days
TAR1 night
Time frame: 14 days
TAR1 day
Time frame: 14 days
TAR2 night
Time frame: 14 days
TAR2 day
Time frame: 14 days
Coefficient of variation (CV)
Time frame: 14 days
Mean sensor glucose
Time frame: 14 days
Standard deviation of mean glucose (SD)
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Derived from this study: PubMed 40897486Nitschke 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrik Pedersen-Bjergaard, Professor contact
Ulrik Pedersen-Bjergaard, Professor principal investigator
Copenhagen University Hospital, North Zealand - Hollered
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Nordsjaellands Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mette J Nitschke, PhD Student (+45 41 24 72 16, mette.juul.nitschke@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Distress (time frame: At baseline and after 14 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06453434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.