Periodic Continuous Glucose Monitoring in Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05633628
• Other study ID #: Periodic Glucose Insights
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: Sophiahemmet University
• Contact: Unn-Britt Johanssson, Professor
• Phone: +4684062902
• Email: unn-britt.johansson[@]shh.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Sweden	Sophiahemmet University	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Sophiahemmet University	OneTwo Analytics AB, Sophiahemmet, Swedish Diabetes Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	mmol/mol	change at week 16
Secondary	Percentage of time spent in range (Glucose)	3.9-10 mmol/l as analyzed by OneTwo Analytics CE marked Decision support Clinic	change first 28 days in the study compared with the last 28 days
Secondary	Percentage time spent in hyperglycaemia	> 10 mmol/L as analyzed by OneTwo Analytics CE marked Decision support Clinic	change first 28 days in the study compared with the last 28 days
Secondary	Percentage time spent in hypoglycaemia	< 3.9 mmol/L as analyzed by OneTwo Analytics CE marked Decision support Clinic	change first 28 days in the study compared with the last 28 days
Secondary	Average glucose value	mmol/L as analyzed by OneTwo Analytics CE marked Decision support Clinic	change first 28 days in the study compared with the last 28 days
Secondary	Standard deviation for glucose value	SD as analyzed by OneTwo Analytics CE marked Decision support Clinic	change first 28 days in the study compared with the last 28 days
Secondary	Percentage time in euglycemia, time in target	3.9-8.0 mmol/L as analyzed by OneTwo Analytics CE marked Decision support Clinic	change first 28 days in the study compared with the last 28 days
Secondary	Number of hyperglycemic episodes per day	Number of hyperglycemic episodes per day as analyzed by OneTwo Analytics CE marked Decision support Clinic	change first 28 days in the study compared with the last 28 days
Secondary	Number of hypoglycemic episodes per day	Number of hypoglycemic episodes per day as analyzed by OneTwo Analytics CE marked Decision support Clinic	change first 28 days in the study compared with the last 28 days
Secondary	Data availability in % of all time	Data availability in % of all time as analyzed by OneTwo Analytics CE marked Decision support Clinic	change first 28 days in the study compared with the last 28 days
Secondary	Prandial delta within 2 hours, post - pre-prandial values for breakfast, lunch and dinner.	Prandial delta within 2 hours, post - pre-prandial values for breakfast, lunch and dinner as analyzed by OneTwo Analytics CE marked Decision support Clinic	change first 28 days in the study compared with the last 28 days
Secondary	Postprandial peak during 2 hours for breakfast, lunch and dinner.	Postprandial peak during 2 hours for breakfast, lunch and dinner as analyzed by OneTwo Analytics CE marked Decision support Clinic	change first 28 days in the study compared with the last 28 days
Secondary	Night-time insulin effect	Night-time insulin effect as analyzed by OneTwo Analytics CE marked Decision support Clinic	change first 28 days in the study compared with the last 28 days
Secondary	Fasting glucose level	Fasting glucose level as analyzed by OneTwo Analytics CE marked Decision support Clinic	change first 28 days in the study compared with the last 28 days
Secondary	The Diabetes Treatment Satisfaction questionnaire	Includes eight items related to the diabetes treatment over the past weeks.	change at week 16
Secondary	WHO-5 Well-Being Index	Brief well-being questionnaire with five items in relation to previous 2 weeks	change at week 16
Secondary	The Patient Preferences for Patient Participation (4Ps)	The 4Ps is a questionnaire including 12 items comprising patient´s preferences as well as experiences.	change at week 16