Periodic Continuous Glucose Monitoring in Patients With Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Periodic CGM group with data analysis report- Intervention group.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- HbA1c [Time frame: change at week 16]
Secondary outcome measures (12)
- Percentage of time spent in range (Glucose) [Time frame: change first 28 days in the study compared with the last 28 days]
- Percentage time spent in hyperglycaemia [Time frame: change first 28 days in the study compared with the last 28 days]
- Percentage time spent in hypoglycaemia [Time frame: change first 28 days in the study compared with the last 28 days]
- Average glucose value [Time frame: change first 28 days in the study compared with the last 28 days]
- Standard deviation for glucose value [Time frame: change first 28 days in the study compared with the last 28 days]
- Percentage time in euglycemia, time in target [Time frame: change first 28 days in the study compared with the last 28 days]
- Number of hyperglycemic episodes per day [Time frame: change first 28 days in the study compared with the last 28 days]
- Number of hypoglycemic episodes per day [Time frame: change first 28 days in the study compared with the last 28 days]
- Data availability in % of all time [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. [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. [Time frame: change first 28 days in the study compared with the last 28 days]
- Night-time insulin effect [Time frame: change first 28 days in the study compared with the last 28 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Sweden · 1 center
- Sophiahemmet University — Stockholm
Identifiers
NCT: NCT05633628 · Periodic Glucose Insights