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NCT Number: NCT05633628

Periodic Continuous Glucose Monitoring in Patients With Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sophiahemmet University

Stockholm, Sweden

Location status: Recruiting

Location contact

Unn-Britt Johansson, PhD

CONTACT

About this study

This is a 16-week prospective, multicenter, randomised, open-labelled, two-armed study in adults with type 2 diabetes conducted at primary care practices in Sweden.

Periodic CGM group- Intervention group:

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 2 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-care management 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.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. HbA1c

    Time frame: change at week 16

    mmol/mol

Secondary outcomes

  1. Percentage of time spent in range (Glucose)

    Time frame: change first 28 days in the study compared with the last 28 days

    3.9-10 mmol/l as analyzed by OneTwo Analytics CE marked Decision support Clinic

  2. Percentage time spent in hyperglycaemia

    Time frame: change first 28 days in the study compared with the last 28 days

    > 10 mmol/L as analyzed by OneTwo Analytics CE marked Decision support Clinic

  3. Percentage time spent in hypoglycaemia

    Time frame: change first 28 days in the study compared with the last 28 days

    < 3.9 mmol/L as analyzed by OneTwo Analytics CE marked Decision support Clinic

  4. Average glucose value

    Time frame: change first 28 days in the study compared with the last 28 days

    mmol/L as analyzed by OneTwo Analytics CE marked Decision support Clinic

  5. Standard deviation for glucose value

    Time frame: change first 28 days in the study compared with the last 28 days

    SD as analyzed by OneTwo Analytics CE marked Decision support Clinic

  6. Percentage time in euglycemia, time in target

    Time frame: change first 28 days in the study compared with the last 28 days

    3.9-8.0 mmol/L as analyzed by OneTwo Analytics CE marked Decision support Clinic

  7. Number of hyperglycemic episodes per day

    Time frame: change first 28 days in the study compared with the last 28 days

    Number of hyperglycemic episodes per day as analyzed by OneTwo Analytics CE marked Decision support Clinic

  8. Number of hypoglycemic episodes per day

    Time frame: change first 28 days in the study compared with the last 28 days

    Number of hypoglycemic episodes per day as analyzed by OneTwo Analytics CE marked Decision support Clinic

  9. Data availability in % of all time

    Time frame: change first 28 days in the study compared with the last 28 days

    Data availability in % of all time as analyzed by OneTwo Analytics CE marked Decision support Clinic

  10. Prandial delta within 2 hours, post - pre-prandial values for breakfast, lunch and dinner.

    Time frame: change first 28 days in the study compared with the last 28 days

    Prandial delta within 2 hours, post - pre-prandial values for breakfast, lunch and dinner as analyzed by OneTwo Analytics CE marked Decision support Clinic

  11. Postprandial peak during 2 hours for breakfast, lunch and dinner.

    Time frame: change first 28 days in the study compared with the last 28 days

    Postprandial peak during 2 hours for breakfast, lunch and dinner as analyzed by OneTwo Analytics CE marked Decision support Clinic

  12. Night-time insulin effect

    Time frame: change first 28 days in the study compared with the last 28 days

    Night-time insulin effect as analyzed by OneTwo Analytics CE marked Decision support Clinic

  13. Fasting glucose level

    Time frame: change first 28 days in the study compared with the last 28 days

    Fasting glucose level as analyzed by OneTwo Analytics CE marked Decision support Clinic

  14. The Diabetes Treatment Satisfaction questionnaire

    Time frame: change at week 16

    Includes eight items related to the diabetes treatment over the past weeks.

  15. WHO-5 Well-Being Index

    Time frame: change at week 16

    Brief well-being questionnaire with five items in relation to previous 2 weeks

  16. The Patient Preferences for Patient Participation (4Ps)

    Time frame: change at week 16

    The 4Ps is a questionnaire including 12 items comprising patient´s preferences as well as experiences.

Study contacts

Contact information is provided by the study sponsor or research team.

Unn-Britt Johanssson, Professor

CONTACT

[email protected]

+4684062902

Sponsors and collaborators

Lead sponsor

Sophiahemmet University

Other

Collaborators

  • OneTwo Analytics AB
  • Sophiahemmet
  • Swedish Diabetes Foundation

Registry information

Official study title

Periodic Continuous Glucose Monitoring to Support a Person-centered Approach During Diabetes Consultations in Patients With Type 2 Diabetes- A Randomised Controlled Study

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 1, 2022
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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