Starter Kit Study in Insulin naïve Patients

NCT ID: NCT03365180

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-03
• Study Completion Date: 2020-01-15

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The Starter Kit Algorithm

Basal insulin initiation and titration using the Starter Kit Algorithm at two weeks, followed by standard of care titration during the following the next 10 weeks (maximum), or until optimal daily dose is considered identified.

Group Type: EXPERIMENTAL

Starter Kit Algorithm

Intervention Type: DEVICE

Long acting insulin titration to target

Interventions

Starter Kit Algorithm

Long acting insulin titration to target

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Type 2 diabetes
• Age 18-75 years
• HbA1c 53-86 mmol/mol (7.0-10.0%)
• BMI 20-40 kg/m2
• Insulin-naïve
• Willingness to use CGM consistently during the study period and send/receive data and dose advice to/from HCP via a mobile phone
• Signed informed consent prior to any study procedures

Exclusion Criteria

• Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
• Active proliferative retinopathy
• Mean blood glucose > 15 mmol/l the week prior to screening
• Blood glucose > 20 mmol/l on the screening day
• Non-fasting ketones > 0,5 mmol/l on the screening day
• Use of sulfonylurea within 14 days prior to or during the study period
• Change in other antidiabetic medicine than basal insulin during the study period
• Use of corticosteroids within 30 days prior to or during the study period
• Marked change in lifestyle within 30 days prior to or during the study period as assessed by the investigator
• People with type 2 diabetes that suffer from conditions which make tight diabetes control undesirable, e.g. severe cardiovascular disease, according to the investigator
• Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
• Overall treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Denmark

OTHER

Sponsor Role: collaborator

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Signe Schmidt

OTHER

Sponsor Role: lead

Responsible Party

Signe Schmidt

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hvidovre University Hospital

Hvidovre, , Denmark

Countries

Denmark

References

Aradottir TB, Bengtsson H, Jensen ML, Poulsen NK, Boiroux D, Jensen LL, Schmidt S, Norgaard K. Feasibility of a New Approach to Initiate Insulin in Type 2 Diabetes. J Diabetes Sci Technol. 2021 Mar;15(2):339-345. doi: 10.1177/1932296819900240. Epub 2020 Jan 15.

Reference Type: RESULT

PMID: 31941361 (View on PubMed)

Other Identifiers

StarterKit2017

Identifier Type: -

Identifier Source: org_study_id