Clinical trial NCT03365180: Starter Kit Study in Insulin naïve Patients
Official title: Starter Kit Study in Insulin naïve Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Technical University of Denmark
name: Novo Nordisk A/S
First posted: 2017-12-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Accuracy of estimate 1
timeFrame: through study completion, 12 weeks
measure: Accuracy of estimate 2
timeFrame: through study completion, 12 weeks
Secondary outcomes:
measure: Accuracy of estimate 3
timeFrame: through study completion, 12 weeks
measure: Number of patients in glucose target
timeFrame: through study completion, 12 weeks
measure: Algorithm deviations
timeFrame: 12 weeks (total duration of study)
measure: Quality of treatment 1
timeFrame: through study completion, 12 weeks
measure: Quality of treatment 2
timeFrame: through study completion, 12 weeks
measure: Number of self-monitored blood glucose values ≤3.9 mmol/L
timeFrame: 12 weeks (total duration of study)
measure: Number of self-monitored blood glucose values ≤3.0 mmol/L
timeFrame: 12 weeks (total duration of study)
measure: Severe hypoglycemia
timeFrame: 12 weeks (total duration of study)
measure: Time spent in hypoglycemia
timeFrame: 8 days (first four and last four days of study)
measure: Time spent in hyperglycemia
timeFrame: 8 days (first four and last four days of study)
measure: Time spent in normoglycemia
timeFrame: 8 days (first four and last four days of study)
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
References:
citation: 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.