Diabetes Self-management With Continuous Glucose Monitoring
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of Continuous Glucose Monitoring Based Self-management on Patient-Reported Outcomes and Glycaemia in Type 1 Diabetes
Overview
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)
Primary outcome measures
- Diabetes Distress [Time frame: At baseline and after 14 days.]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Denmark · 2 centers
- Steno Diabetes Center Copenhagen — Herlev
- Copenhagen University Hospital, North Zealand - Hilleroed — Hillerød
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. PMID 40897486
Identifiers
NCT: NCT06453434 · U1111-1306-6133