Periodic Continuous Glucose Monitoring in Patients With Type 2 Diabetes

NCT05633628 | Recruiting

• 1 other identifier: Periodic Glucose Insights
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomised controlled trial is to investigate the effectiveness of periodic CGM (continuous glucose monitoring) to support a person-centered approach versus self-monitoring of blood glucose (SMBG) in adults with type 2 diabetes on glucose control and patient reported outcomes.

Conditions

Type 2 Diabetes

Keywords

CGM; Personcentered care

Outcome Measures

Primary Outcomes (1)

• HbA1c

  mmol/mol

  change at week 16

Secondary Outcomes (16)

• Percentage of time spent in range (Glucose)

  change first 28 days in the study compared with the last 28 days

• Percentage time spent in hyperglycaemia

  change first 28 days in the study compared with the last 28 days

• Percentage time spent in hypoglycaemia

  change first 28 days in the study compared with the last 28 days

• Average glucose value

  change first 28 days in the study compared with the last 28 days

• Standard deviation for glucose value

  change first 28 days in the study compared with the last 28 days

Study Arms (2)

Periodic CGM- Intervention group

EXPERIMENTAL

The participants in the intervention group will be provided with FreeStyle Libre (Abbott Diabetes Care). Participants wear the sensor and check their glucose level for a period of 28 days (14 days X 2) during week 0-4 and week 10-13.Patient's measurement data from the FreeStyle Libre system will be transferred to the OneTwo Analytics (DDA) analysis tool for an automated analysis and this Insight report will be presented to the participants at visit week 4 (digital) and at visit week 16 (clinical). The diabetes nurse and the patient reviews and discuss trends, patterns, and challenges to support the person's self-management care of their type 2 diabetes. This approach is intended to facilitate communication and patient participation and create the conditions for shared informed decisions and health planning.

Behavioral: Periodic CGM group with data analysis report- Intervention group

Self-monitoring of blood glucose, SMBG and usual care - Control Group

NO INTERVENTION

The participants in the control group perform SMBG testing as usual including fasting, pre- or post-prandial measurements. They also receive usual care which comprises consultation with physician diabetes specialist or diabetes nurse depending on individual health care needs.

Interventions

Periodic CGM group with data analysis report- Intervention group BEHAVIORAL

The patients are also instructed to continue to perform SMBG by finger prick if they experience symptoms of hypo- or hyperglycemia. During visit 0 (baseline) the patients is also instructed about how they can log in to the National Diabetes Register (NDR) to access their own NDR's recorded data and use the diabetes questionnaire.

Periodic CGM- Intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-80 years
• Type 2 diabetes with a duration of \> 6 months
• HbA1c 45-70 mmol/mol
• Have a smartphone
• Experience of self-monitoring of blood glucose prior to the study start

You may not qualify if:

• Prandial insulin
• Pregnancy or planning pregnancy during the study
• Breastfeeding
• Renal disease with estimated glomerular filtration rate (eGFR) \<45 mL/ min/1.73 m2
• Active malignancy or under investigation for malignancy
• Severe visual impairment
• Severe skin allergy that inhibits the use of a continuous glucose monitoring device
• Glucocorticoids (systemic)
• Planned or currently using weight reduction medications, programs, or surgery
• Cognitively or psychologically unable to participate and read instructions
• Enrolled in other clinical trials
• Eating disorders

Sponsors & Collaborators

• Sophiahemmet University: lead
• OneTwo Analytics AB: collaborator
• Swedish Diabetes Foundation: collaborator
• Sophiahemmet: collaborator

Study Sites (1)

Sophiahemmet University

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Unn-Britt Johansson

  Sophiahemmet University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Unn-Britt Johanssson, Professor

CONTACT

+4684062902; unn-britt.johansson@shh.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: February 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)