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Completed

NCT Number: NCT03365180

Starter Kit Study in Insulin naïve Patients

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).

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Starter Kit Algorithm

Device

Long acting insulin titration to target

Primary outcomes

  1. Accuracy of estimate 1

    Time frame: through study completion, 12 weeks

    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.

  2. Accuracy of estimate 2

    Time frame: through study completion, 12 weeks

    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

Secondary outcomes

  1. Accuracy of estimate 3

    Time frame: through study completion, 12 weeks

    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.

  2. Number of patients in glucose target

    Time frame: through study completion, 12 weeks

    Number of participants in target at end of study

  3. Algorithm deviations

    Time frame: 12 weeks (total duration of study)

    Number of titration algorithm deviations due to risk of hypoglycemia (based on evaluation of CGM data)

  4. Quality of treatment 1

    Time frame: through study completion, 12 weeks

    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.

  5. Quality of treatment 2

    Time frame: through study completion, 12 weeks

    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.

  6. Number of self-monitored blood glucose values ≤3.9 mmol/L

    Time frame: 12 weeks (total duration of study)

    Number of self-monitored blood glucose values ≤3.9 mmol/L

  7. Number of self-monitored blood glucose values ≤3.0 mmol/L

    Time frame: 12 weeks (total duration of study)

    Number of self-monitored blood glucose values ≤3.0 mmol/L

  8. Severe hypoglycemia

    Time frame: 12 weeks (total duration of study)

    Number of severe hypoglycemic events (defined as severe cognitive impairment requiring external assistance for recovery).

  9. Time spent in hypoglycemia

    Time frame: 8 days (first four and last four days of study)

    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).

  10. Time spent in hyperglycemia

    Time frame: 8 days (first four and last four days of study)

    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).

  11. Time spent in normoglycemia

    Time frame: 8 days (first four and last four days of study)

    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).

Sponsors and collaborators

Lead sponsor

Signe Schmidt

Other

Collaborators

  • Novo Nordisk A/S
  • Technical University of Denmark

Registry information

Official study title

Starter Kit Study in Insulin naïve Patients With Type 2 Diabetes

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 7, 2017
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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