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Steno2tech - Continuous Glucose Monitoring and Type 2 Diabetes.

NCT04331444 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-10-12

No results posted yet for this study

Summary

The overall objective of this research study is to examine the effectiveness of the use of CGM vs. SMBG in persons with insulin-treated type 2 diabetes on glycemic variables and patient reported outcomes on treatment satisfaction, health behavior and wellbeing. The independent effect of peer-support will also be studied.

Conditions

  • Type 2 Diabetes Treated With Insulin

Interventions

DEVICE

CGM

Using the CGM during the entire study period of 12 months.

BEHAVIORAL

training course

The participants in the three groups will attend a three-hour training course with different content depending on the group allocation. The aim of this training course is to ensure that the participants have the knowledge, support and confidence to work collaboratively with their HCPs to increase TIR and decrease HbA1c.

BEHAVIORAL

Peer-support

The peer-support will be facilitator-led by the primary investigator with peer exchange in group sessions (3 sessions over the study period, 3 hours per session) with 6-8 participants in every group.

Sponsors & Collaborators

  • Steno Diabetes Center Copenhagen

    lead OTHER

Principal Investigators

  • Nanna Lind, RN MSc · Steno Diabetes Center Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2023-07-01
Completion
2023-07-01

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 NCT04331444 on ClinicalTrials.gov