Not Yet RecruitingNot Applicable

Diabetes Self-management With Continuous Glucose Monitoring

Denmark500 participantsStarted 2024-07-01

Plain-language 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

Who can participate

Age range18 Years – 85 Years

SexALL

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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.

What they're measuring

Diabetes Distress

Timeframe: At baseline and after 14 days.

Trial details

NCT IDNCT06453434

SponsorNordsjaellands Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-08

Contact for this trial

Mette J Nitschke, PhD Student

+45 41 24 72 16 mette.juul.nitschke@regionh.dk

View on ClinicalTrials.gov More Type 1 Diabetes trials