Periodic Continuous Glucose Monitoring in Patients With Type 2 Diabetes

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Periodic CGM group with data analysis report- Intervention group

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Unn-Britt Johanssson, Professor; Phone Number: +4684062902; Email: unn-britt.johansson@shh.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Sophiahemmet University
    • Contact: Unn-Britt Johansson, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: Periodic CGM- 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 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	mmol/mol	change at week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
The Diabetes Treatment Satisfaction questionnaire	Includes eight items related to the diabetes treatment over the past weeks.	change at week 16
WHO-5 Well-Being Index	Brief well-being questionnaire with five items in relation to previous 2 weeks	change at week 16
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

Collaborators and Investigators

• Sponsor: Sophiahemmet University
• Collaborators: Swedish Diabetes Foundation; OneTwo Analytics AB; Sophiahemmet
• Investigators: Principal Investigator: Unn-Britt Johansson, Sophiahemmet University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: CGM; Personcentered care
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Periodic Glucose Insights

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No