Clinical trial NCT05633628: Periodic Continuous Glucose Monitoring in Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: CGM
Personcentered care
Lead sponsor: Sophiahemmet University
Sponsor class: OTHER
Collaborators: name: Swedish Diabetes Foundation
name: OneTwo Analytics AB
name: Sophiahemmet
First posted: 2022-12-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: change at week 16
Secondary outcomes:
measure: Percentage of time spent in range (Glucose)
timeFrame: change first 28 days in the study compared with the last 28 days
measure: Percentage time spent in hyperglycaemia
timeFrame: change first 28 days in the study compared with the last 28 days
measure: Percentage time spent in hypoglycaemia
timeFrame: change first 28 days in the study compared with the last 28 days
measure: Average glucose value
timeFrame: change first 28 days in the study compared with the last 28 days
measure: Standard deviation for glucose value
timeFrame: change first 28 days in the study compared with the last 28 days
measure: Percentage time in euglycemia, time in target
timeFrame: change first 28 days in the study compared with the last 28 days
measure: Number of hyperglycemic episodes per day
timeFrame: change first 28 days in the study compared with the last 28 days
measure: Number of hypoglycemic episodes per day
timeFrame: change first 28 days in the study compared with the last 28 days
measure: Data availability in % of all time
timeFrame: change first 28 days in the study compared with the last 28 days
measure: Prandial delta within 2 hours, post - pre-prandial values for breakfast, lunch and dinner.
timeFrame: change first 28 days in the study compared with the last 28 days
measure: Postprandial peak during 2 hours for breakfast, lunch and dinner.
timeFrame: change first 28 days in the study compared with the last 28 days
measure: Night-time insulin effect
timeFrame: change first 28 days in the study compared with the last 28 days
measure: Fasting glucose level
timeFrame: change first 28 days in the study compared with the last 28 days
measure: The Diabetes Treatment Satisfaction questionnaire
timeFrame: change at week 16
measure: WHO-5 Well-Being Index
timeFrame: change at week 16
measure: The Patient Preferences for Patient Participation (4Ps)
timeFrame: change at week 16
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Sophiahemmet University
Study officials:
affiliation: Sophiahemmet University
name: Unn-Britt Johansson
role: PRINCIPAL_INVESTIGATOR
References: