Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Starter Kit Study in Insulin naïve Patients

Lead Sponsor:

Signe Schmidt

Collaborating Sponsors:

Technical University of Denmark

Novo Nordisk A/S

Conditions:

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

PHASE3

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 dur...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 3 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 15 2020

Estimated Enrollment :

8 Patients enrolled

Trial Details

Trial ID

NCT03365180

Start Date

January 3 2018

End Date

January 15 2020

Last Update

February 12 2020

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Hvidovre University Hospital

Hvidovre, Denmark, 2650