Periodic Continuous Glucose Monitoring in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Periodic CGM group with data analysis report- Intervention group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Periodic CGM- Intervention group<br>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<br>* 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.<br>|
| No Intervention: Self-monitoring of blood glucose, SMBG and usual care - Control Group<br>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. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CGM, Personcentered care