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Assessing the use of FreeStyle Libre Pro with HbA1c in diabetes management

Pilot Study to Assess use of FreeStyle Libre Pro with HbA1c in Determining Diabetes Management

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN36033130
Enrollment
45
Registered
2019-10-14
Start date
2019-10-21
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus (Diabetes) Nutritional, Metabolic, Endocrine Diabetes Mellitus

Interventions

Sponsors

Abbott Diabetes Care Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age at least 18 years 2. Type 2 diabetes, on oral glucose-lowering medication, or, oral glucose-lowering medication and biphasic insulin

Exclusion criteria

Exclusion criteria: 1. Currently prescribed basal insulin 2. Currently prescribed bolus insulin 3. Currently prescribed glucagon-like peptide 1 (GLP-1) without being prescribed biphasic insulin 4. Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition 5. Has a pacemaker or any other neurostimulators 6. Currently receiving dialysis treatment or planning to receive dialysis during the study 7. Women who are pregnant, plan to become pregnant or become pregnant during the study 8. Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management 9. Known (or suspected) allergy to medical grade adhesives 10. In the investigator’s opinion the participant is unsuitable to participate due to any other cause/reason

Design outcomes

Primary

MeasureTime frame
Responses to HCP questionnaire using HbA1c results alone Responses to a second questionnaire using HbA1c results and the reports generated from the FreeStyle Libre Pro system

Secondary

MeasureTime frame
Glycaemic measures, measured using sensor glucose data collected by the FreeStyle Libre Pro Flash Glucose Monitoring System during the two-week study duration. 1. Time in hypoglycaemia (10.0 mmol/L) 3. Time in range (3.9-10.0 mmol/L) 4. Mean glucose, SD glucose and CV glucose

Countries

England, United Kingdom

Contacts

Public ContactPamela Reid
Pamela.Reid@abbott.com+44 (0)1993 863024

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026