Starter Kit Study in Insulin naïve Patients

Study Overview
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Brief Summary
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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).

Official Title
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Starter Kit Study in Insulin naïve Patients With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Starter Kit Algorithm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Starter Kit Algorithm<br>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<br>* Long acting insulin titration to target<br>|

What is the study measuring?
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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) |