N/A
Completed N=472
CGM Precision and Glycaemic Variability
Diabetes Type 1
Source: ClinicalTrials.gov NCT03842683 ↗
Enrolled (actual)
472
Serious AEs
—
Results posted
Nov 2019
Primary outcomePrimary: Optimal Time Shift of Continuous Glucose Monitoring Measurements — 1.01 Percentage point change in MARD
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 should be used in drug development to evaluate efficacy and safety. However, the devices have been criticised for being too inaccurate. This investigation sought to reveal the inaccuracies of current devices and to assess the subsequent usability related to the mentioned use cases.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Optimal Time Shift of Continuous Glucose Monitoring Measurements |
1.01 | — |
| SECONDARY Area Under the Receiver Operating Characteristics Curve of the Hypoglycemia Prediction |
0.79 | — |
Eligibility Criteria
As copied from the original clinical trial ClinicalTrials.gov Identifier: NCT02825251
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03842683). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.