Status:
COMPLETED
CGM Precision and Glycaemic Variability
Lead Sponsor:
Peter Vestergaard
Conditions:
Diabetes Type 1
Eligibility:
All Genders
18+ years
Brief Summary
Use of devices for continuous monitoring of the blood sugar is valuable for people with diabetes to understand their disease and to help prevent low blood sugar. Furthermore, continuous monitoring sho...
Detailed Description
The following study is an exploratory investigation of continuous glucose monitoring based on data from a completed Novo Nordisk A/S clinical trial. Please refer to ClinicalTrials.gov Identifier: NCT0...
Eligibility Criteria
Inclusion
- As copied from the original clinical trial ClinicalTrials.gov Identifier: NCT02825251
- Male or female, age at least 18 years at the time of signing the informed consent
- Diagnosed with T1DM (Type 1 Diabetes Mellitus) (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) equal or above 1 year prior to the day of screening
- Using the same Medtronic pump (Minimed 530G (551/751), Paradigm Veo (554/754), Paradigm Revel (523/723), Paradigm (522/722)) for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least six months prior to screening and willing to stay on the same pump model throughout the trial (if the model is changed the change should not exceed 7 consecutive days.)
- HbA1c (glycosylated haemoglobin) 7.0-9.0% (53-75 mmol/mol) as assessed by central laboratory at screening
- Body mass index (BMI) below or equal to 35.0 kg/m\^2 at screening
- Ability and willingness to take at least 3 daily meal-time insulin bolus infusions every day throughout the trial
Exclusion
- Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- History of hospitalization for ketoacidosis below or equal to 180 days prior to the day of screening
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening
- Any condition which, in the opinion of the Investigator, might jeopardise a Subject's safety or compliance with the protocol
Key Trial Info
Start Date :
June 6 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 20 2017
Estimated Enrollment :
472 Patients enrolled
Trial Details
Trial ID
NCT03842683
Start Date
June 6 2016
End Date
June 20 2017
Last Update
November 20 2019
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