NCT03365180

Starter Kit Study in Insulin naïve Patients

Completed Phase 2, PHASE3 Last updated 12 February 2020

What this trial tests

Phase 2, PHASE3 trial testing Starter Kit Algorithm in Diabetes Mellitus, Type 2 in 8 participants. Completed in 15 January 2020.

Timeline

3 January 2018

Primary endpoint
1 November 2019

15 January 2020

Quick facts

Lead sponsor	Signe Schmidt
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	3 January 2018
Primary completion	1 November 2019
Estimated completion	15 January 2020
Sites	1 location across Denmark

Drugs / interventions tested

• Starter Kit Algorithm

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Signe Schmidt

Who can join

Adults 18 to 75, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Feasibility of a New Approach to Initiate Insulin in Type 2 Diabetes.
   Aradóttir TB, Bengtsson H, Jensen ML, Poulsen NK, et al · · 2021 · cited 6× · PMID 31941361 · DOI 10.1177/1932296819900240