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Starter Kit Study in Insulin naïve Patients

NCT03365180 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-02-12

No results posted yet for this study

Summary

The concept consists of an initial period (two weeks) of intensive data capture by use of continuous glucose monitoring (CGM) during basal insulin initiation, followed by a second period (variable duration) of basal insulin titration guided by self monitored blood glucose. Data captured during the first period are used as input to an algorithm that estimates the optimal daily dose for the individual patient. The estimated optimal daily dose is used to guide the titration of the basal insulin during the second period. The goal is to safely and successfully achieve blood glucose targets. The concept is based on the use of basal insulin degludec (Tresiba, Novo Nordisk A/S).

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DEVICE

Starter Kit Algorithm

Long acting insulin titration to target

Sponsors & Collaborators

  • Technical University of Denmark

    collaborator OTHER

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Signe Schmidt

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-01-03
Primary Completion
2019-11-01
Completion
2020-01-15

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Companies

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 NCT03365180 on ClinicalTrials.gov