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The Effects of CGM and Connected Pen in T2DM Treated With Multiple Daily Insulin Injections

NCT06311019 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2024-11-07

No results posted yet for this study

Summary

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.

Conditions

  • Type 2 Diabetes Treated With Insulin

Interventions

DEVICE

Continuous glucose monitoring and use of connected insulinpen for bolus insulin

Continuous glucose monitoring (Abbott Freestyle Libre 2) and use of connected insulinpen (Novopen 6) for bolus insulin

Sponsors & Collaborators

  • Steno Diabetes Center Aarhus, Denmark

    collaborator UNKNOWN

  • Klavs Würgler Hansen

    lead OTHER

Principal Investigators

  • Klavs W Hansen · Medical Diagnostic Center, Silkeborg Regional Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-27
Primary Completion
2025-07-01
Completion
2025-09-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06311019 on ClinicalTrials.gov