protocolSection identificationModule nctId: NCT06311019, orgStudyIdInfo id: 791572, briefTitle: The Effects of CGM and Connected Pen in T2DM Treated With Multiple Daily Insulin Injections, acronym: Dia2tech, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Klavs Würgler Hansen, class: OTHER, collaborators name: Steno Diabetes Center Aarhus, Denmark, descriptionModule briefSummary: The aim of the study is to evaluate the effect of a combination of 12 months treatment with CGM (Freestyle Libre 2) with hypo and hyper alert in combination with a smart pen for bolus insulin (NOVOpen6) on HbA1c and time in range (TIR) in T2DM patients with baseline HbA1c \>53 mmol/mol (7. 0%, eAG 8,6 mmol/l) as compared with standard care., conditionsModule conditions: Type 2 Diabetes Treated With Insulin, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Continuous glucose monitoring and use of connected insulinpen for bolus insulin, outcomesModule primaryOutcomes measure: Change in Haemoglobin A1c, secondaryOutcomes measure: Change Time in range, secondaryOutcomes measure: Change in Time above range, secondaryOutcomes measure: Change in Time below range, secondaryOutcomes measure: Mean glucose, secondaryOutcomes measure: Standard deviation, secondaryOutcomes measure: Change in CV, secondaryOutcomes measure: Change in Time with rapid glucose change, secondaryOutcomes measure: Change in ARRC, secondaryOutcomes measure: Fraction of patients with increased number of bolus insulin per day, otherOutcomes measure: Fingerprick glucose measurement, otherOutcomes measure: Glucose views on mobile phone, otherOutcomes measure: Use of Novopen 6 memory function, otherOutcomes measure: WHO-5, otherOutcomes measure: Diabetes Distress Scale, otherOutcomes measure: Revised short form of hypoglycaemia Fear Survey, otherOutcomes measure: eHealth literacy questionnaire (eHLQ),, otherOutcomes measure: The Glucose Monitoring Satisfaction Questionnaire, otherOutcomes measure: Diabetes Treatment Satisfaction Questionnaire (DTSQ), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Steno Diabetes Center Aarhus, status: NOT_YET_RECRUITING, city: Aarhus, zip: 8000, country: Denmark, contacts name: Katrine B Gørlitz, MD, role: CONTACT, phone: +45 24210787, email: KAGOER@rm.dk, contacts name: Søren Gregersen, Professor, role: CONTACT, phone: +45 30134245, email: soeren.gregersen@aarhus.rm.dk, geoPoint lat: 56.15674, lon: 10.21076, locations facility: Regional Hospital Silkeborg, Central Jutland Hospital, status: RECRUITING, city: Silkeborg, zip: 8600, country: Denmark, contacts name: Katrine B Gørlitz, MD, role: CONTACT, phone: +45 24210787, email: KAGOER@rm.dk, contacts name: Klavs W Hansen, Professor, role: CONTACT, phone: +45 78417847, email: klavhans@rm.dk, geoPoint lat: 56.1697, lon: 9.54508, hasResults: False