NCT06453434

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jul 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jul 2024Aug 2026

First Submitted

Initial submission to the registry

May 30, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

June 11, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

May 30, 2024

Last Update Submit

June 5, 2024

Conditions

Type 1 Diabetes

Keywords

Continuous Glucose MonitoringSelf-managementDiabetes TechnologyType 1 DiabetesDiabetes DistressPatient-reported Outcomes

Outcome Measures

Primary Outcomes (1)

  • 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.

    At baseline and after 14 days.

Secondary Outcomes (17)

  • Time in range (TIR)

    14 days

  • Time in tight range (TIR)

    14 days

  • Time below range level 1 (TBR1)

    14 days

  • Time below range level 2 (TBR2)

    14 days

  • TBR1 night

    14 days

  • +12 more secondary outcomes

Other Outcomes (44)

  • Frequency of daily CGM readings

    14 days

  • Diurnal variation of daily CGM readings

    14 days

  • Active sensor

    14 days

  • +41 more other outcomes

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with type 1 diabetes (n=500) on multiple daily insulin injections already using FreeStyle Libre 2.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Steno Diabetes Center Copenhagen

Herlev, Capital Region, 2730, Denmark

Location

Copenhagen University Hospital, North Zealand - Hilleroed

Hillerød, Capital Region, 3400, Denmark

Location

Related Publications (1)

  • 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: 40897486DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ulrik Pedersen-Bjergaard, Professor

    Copenhagen University Hospital, North Zealand - Hollered

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mette J Nitschke, PhD Student

CONTACT

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

Ulrik Pedersen-Bjergaard, Professor

CONTACT

ulrik.pedersen-bjergaard@outlook.dk

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2024

First Posted

June 11, 2024

Study Start

July 1, 2024

Primary Completion

August 1, 2025

Study Completion (Estimated)

August 1, 2026

Last Updated

June 11, 2024

Record last verified: 2024-04

Locations

DK(2)