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
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.
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Sophiahemmet University | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Sophiahemmet University | OneTwo Analytics AB, Sophiahemmet, Swedish Diabetes Foundation |
Sweden,
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 |
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