Determining variation in glucose levels in people with impaired glucose tolerance (prediabetes)

Not Applicable

Completed

• Conditions: Impaired glucose tolerance; Nutritional, Metabolic, Endocrine; Abnormal glucose tolerance test

• Registration Number: ISRCTN15304729
• Lead Sponsor: Abbott Diabetes Care Ltd

Brief Summary

2020 Abstract results in https://doi.org/10.2337/db20-87-LB (added 01/07/2022) 2020 Abstract results in https://doi.org/10.1007/s00125-020-05221-5 (added 10/06/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-22
• Study Completion: 2019-08-31
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

1. Aged 18 years or over.
2. Most recent HbA1c 5.7-6.4% (39-47 mmol/mol), recorded in medical notes in last 12 months.

Exclusion Criteria

1. Recorded diagnosis of diabetes.
2. 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.
3. Has a pacemaker or any other neurostimulators.
4. Currently receiving dialysis treatment or planning to receive dialysis during the study.
5. Women who are pregnant, plan to become pregnant or become pregnant during the study.
6. Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management.
7. Known (or suspected) allergy to medical grade adhesives.
8. In the investigator’s opinion, unsuitable to participate due to any other cause/reason.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycaemic variability (%CV glucose), measured using sensor glucose data collected by the FreeStyle Libre Pro Flash Glucose Monitoring System during the first two-weeks of the study.

Secondary Outcome Measures

Name	Time	Method
Other glycaemic measures such as time in range (3.9-10.0 mmol/L [70-180 mg/dL]), measured using sensor glucose data collected by the FreeStyle Libre Pro Flash Glucose Monitoring System during the first two-weeks of the study.