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Starter Kit Study in Insulin naïve Patients

This study is currently recruiting participants.
Verified December 2017 by Signe Schmidt, Hvidovre University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03365180
First Posted: December 7, 2017
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Technical University of Denmark
Novo Nordisk A/S
Information provided by (Responsible Party):
Signe Schmidt, Hvidovre University Hospital
  Purpose
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).

Condition Intervention Phase
Diabetes Mellitus, Type 2 Device: Starter Kit Algorithm Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Starter Kit Study in Insulin naïve Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Signe Schmidt, Hvidovre University Hospital:

Primary Outcome Measures:
  • 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.


  • 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 Outcome Measures:
  • 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.

  • Number of patients in glucose target [ Time Frame: through study completion, 12 weeks ]
    Number of participants in target at end of study

  • 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)

  • 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.

  • 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.

  • 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

  • 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

  • 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).

  • 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).

  • 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).

  • 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).


Estimated Enrollment: 10
Anticipated Study Start Date: January 2018
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365180


Contacts
Contact: Kirsten Nørgaard, MD, DMSc 27131011 ext 0045 kirsten.noergaard@regionh.dk

Locations
Denmark
Hvidovre University Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Kirsten Nørgaard, MD, DMSc    27131011 ext 0045    kirsten.noergaard@regionh.dk   
Sponsors and Collaborators
Signe Schmidt
Technical University of Denmark
Novo Nordisk A/S
  More Information

Responsible Party: Signe Schmidt, Principal Investigator, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03365180     History of Changes
Other Study ID Numbers: StarterKit2017
First Submitted: September 6, 2017
First Posted: December 7, 2017
Last Update Posted: December 7, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs