Periodic Continuous Glucose Monitoring in Patients With Type 2 Diabetes
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSophiahemmet University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18-80 years
Type 2 diabetes with a duration of > 6 months
HbA1c 45-70 mmol/mol
Have a smartphone
Disqualifiers
Prandial insulin
Pregnancy or planning pregnancy during the study
Breastfeeding
Renal disease with estimated glomerular filtration rate (eGFR) <45 mL/ min/1.73 m2
Trial design
Design model
Parallel
Treatments tested in this trial
Periodic CGM group with data analysis report- Intervention group
BehavioralThe 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Periodic CGM- Intervention groupExperimental treatment 1 intervention
Group B: Self-monitoring of blood glucose, SMBG and usual care - Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
HbA1c
mmol/mol
Time frame
change at week 16Secondary outcomes
1
Percentage of time spent in range (Glucose)
3.9-10 mmol/l as analyzed by OneTwo Analytics CE marked Decision support Clinic
Time frame
change first 28 days in the study compared with the last 28 days2
Percentage time spent in hyperglycaemia
\> 10 mmol/L as analyzed by OneTwo Analytics CE marked Decision support Clinic
Time frame
change first 28 days in the study compared with the last 28 days3
Percentage time spent in hypoglycaemia
\< 3.9 mmol/L as analyzed by OneTwo Analytics CE marked Decision support Clinic
Time frame
change first 28 days in the study compared with the last 28 days4
Average glucose value
mmol/L as analyzed by OneTwo Analytics CE marked Decision support Clinic
Time frame
change first 28 days in the study compared with the last 28 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sophiahemmet University
Lead sponsor
Swedish Diabetes Foundation
Collaborator
OneTwo Analytics AB
Collaborator
Sophiahemmet
Collaborator
Source ClinicalTrials.gov