Starter Kit Study in Insulin naïve Patients

NCT03365180 | Completed Phase 2 DMC

• 1 other identifier: StarterKit2017
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Accuracy of estimate 1

  Accuracy of the estimated optimal daily dose (calculated by the Starter Kit algorithm based on continuous glucose monitoring (CGM) data collected during day 1-14) compared with the observed optimal daily dose in percentage deviation. In this context, optimal daily dose is the dose considered to keep fasting glucose levels below 6 mmol/L.

  through study completion, 12 weeks

• Accuracy of estimate 2

  The number of estimated optimal daily doses by the Starter Kit Algorithm at two weeks that fall within a patient specific confidence interval. The confidence interval is determined using the Starter Kit Algorithm at the end of study, one interval for each patient. Upper boundary: the optimal daily dose estimated to bring lowest hour of CGM values within a day to 4.0 mmol/L Lower boundary: the optimal daily dose estimated to bring lowest hour of CGM values within a day to 6.0 mmol/L

  through study completion, 12 weeks

Secondary Outcomes (11)

• Accuracy of estimate 3

  through study completion, 12 weeks

• Number of patients in glucose target

  through study completion, 12 weeks

• Algorithm deviations

  12 weeks (total duration of study)

• Quality of treatment 1

  through study completion, 12 weeks

• Quality of treatment 2

  through study completion, 12 weeks

Study Arms (1)

The Starter Kit Algorithm

EXPERIMENTAL

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.

Device: Starter Kit Algorithm

Interventions

Starter Kit Algorithm DEVICE

Long acting insulin titration to target

The Starter Kit Algorithm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Signe Schmidt: lead
• Technical University of Denmark: collaborator
• Novo Nordisk A/S: collaborator

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (1)

• 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.

  PMID: 31941361 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: December 7, 2017
• Study Start: January 3, 2018
• Primary Completion: November 1, 2019
• Study Completion: January 15, 2020
• Last Updated: February 12, 2020

Record last verified: 2020-02

Locations

DK (1)