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Determining the amount of time with low glucose in people using premixed (biphasic) insulin

Pilot study to determine Time in HYpoglycaemia when using pre-MixEd (biphasic) insulin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10603608
Enrollment
40
Registered
2019-05-22
Start date
2019-05-28
Completion date
Unknown
Last updated
2022-08-05

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

Conditions

Type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

Sponsors

Abbott Diabetes Care Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or over. 2. Type 2 diabetes treated with pre-mixed (biphasic) insulin for at least 6 months prior to study enrolment. 3. Most recent HbA1c less than 7.5% (58 mmol/mol), recorded in medical notes in last 12 months.

Exclusion criteria

Exclusion criteria: 1. Currently prescribed animal insulin. 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.

Design outcomes

Primary

MeasureTime frame
Time in hypoglycaemia (<3.9 mmol/L [70 mg/dL]), measured using sensor glucose data collected by the FreeStyle Libre Pro Flash Glucose Monitoring System during the two-week study duration.

Secondary

MeasureTime frame
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 two-week study duration.

Countries

England, Scotland, United Kingdom

Contacts

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

Outcome results

None listed

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