Starter Kit Study in Insulin naïve Patients

Starter Kit Study in Insulin naïve Patients With Type 2 Diabetes

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: Starter Kit Algorithm

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Hvidovre University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Starter Kit Algorithm; Long acting insulin titration to target

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of estimate 3	Accuracy of the estimated optimal daily dose (calculated based on self-monitored blood glucose data collected during day 1-14) compared with the observed optimal daily dose.	through study completion, 12 weeks
Number of patients in glucose target	Number of participants in target at end of study	through study completion, 12 weeks
Algorithm deviations	Number of titration algorithm deviations due to risk of hypoglycemia (based on evaluation of CGM data)	12 weeks (total duration of study)
Quality of treatment 1	Qualitative assessment by the investigator of participants who do not reach the observed optimal daily dose within 12 weeks: Frequency of participants who are in need of additional basal insulin to achieve the target blood glucose.	through study completion, 12 weeks
Quality of treatment 2	Qualitative assessment by the investigator of participants who do not reach the observed optimal daily dose within 12 weeks: Frequency of participants who are in need of additional drugs to achieve the target blood glucose.	through study completion, 12 weeks
Number of self-monitored blood glucose values ≤3.9 mmol/L	Number of self-monitored blood glucose values ≤3.9 mmol/L	12 weeks (total duration of study)
Number of self-monitored blood glucose values ≤3.0 mmol/L	Number of self-monitored blood glucose values ≤3.0 mmol/L	12 weeks (total duration of study)
Severe hypoglycemia	Number of severe hypoglycemic events (defined as severe cognitive impairment requiring external assistance for recovery).	12 weeks (total duration of study)
Time spent in hypoglycemia	Time spent in hypoglycemia (<3.9 mmol/L) assessed by CGM during the first four study days (days without insulin) and the last four study days (days with optimal daily insulin dose).	8 days (first four and last four days of study)
Time spent in hyperglycemia	Time spent in hyperglycemia (>10 mmol/L) assessed by CGM during the first four study days (days without insulin) and the last four study days (days with optimal daily insulin dose).	8 days (first four and last four days of study)
Time spent in normoglycemia	Time spent in normoglycemia (3.9-10.0 mmol/L) assessed by CGM during the first four study days (days without insulin) and the last four study days (days with optimal daily insulin dose).	8 days (first four and last four days of study)

Collaborators and Investigators

• Sponsor: Signe Schmidt
• Collaborators: Novo Nordisk A/S; Technical University of Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: StarterKit2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No