Diabetes Self-management With Continuous Glucose Monitoring

NCT ID: NCT06453434

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-08-31

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

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)

Conditions

Type 1 Diabetes

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 85 years.

2. Diagnosed with T1D over one year ago.

3. Actively using FreeStyle Libre 2 (>80% sensor activity).

4. Used FreeStyle Libre 2 for over three months.

5. Uses multiple daily insulin injections.

6. Capable of providing written informed consent.

7. Willing and able to complete study procedures, including using smart caps or pens and completing questionnaires at the investigator's discretion.

Exclusion Criteria

1. History of allergic reactions to materials or adhesives used in CGM devices.

2. 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.

3. Current use of steroids unless part of a chronic therapy plan.

4. Daily consumption of vitamin C ≥ 500 mg.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role: collaborator

Nordsjaellands Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ulrik Pedersen-Bjergaard, Professor

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital, North Zealand - Hollered

Locations

Steno Diabetes Center Copenhagen

Herlev, Capital Region, Denmark

Copenhagen University Hospital, North Zealand - Hilleroed

Hillerød, Capital Region, Denmark

Countries

Denmark

Central Contacts

Mette J Nitschke, PhD Student

Role: CONTACT

mette.juul.nitschke@regionh.dk

+45 41 24 72 16

Ulrik Pedersen-Bjergaard, Professor

Role: CONTACT

ulrik.pedersen-bjergaard@outlook.dk

Facility Contacts

Kirsten Nørgaard, Professor

Role: primary

kirsten.noergaard@regionh.dk

+45 27 13 10 11

Mette J Nitschke, PhD student

Role: primary

mette.juul.nitschke@regionh.dk

+45 41 24 72 16

References

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.

Reference Type: DERIVED

PMID: 40897486 (View on PubMed)

Other Identifiers

U1111-1306-6133

Identifier Type: -

Identifier Source: org_study_id