A pilot study evaluating two continuous glucose monitoring education strategies for adults with type 2 diabetes in primary care

FOCUS-CGM: A randomised feasibility and acceptability pilot study comparing patient-initiated and clinician-facilitated continuous glucose monitoring education strategies for adults with type 2 diabetes in a UK primary care setting

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14469455

Enrollment

Registered

2026-06-22

Start date

2026-06-25

Completion date

Unknown

Last updated

2026-08-10

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

Interventions

Participants will be randomly allocated in a 1:1 ratio to one of two study groups using a simple randomisation process. All participants will be adults with type 2 diabetes managed in primary care wh

Eligibility

Sex/Gender

All

Age

35 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years and over 2. Diagnosed with type 2 diabetes mellitus 3. Registered at Country Park Practice 4. Not currently using insulin therapy 5. HbA1c above the individualised treatment target and considered suitable for CGM-supported diabetes education by the clinical team 6. Able to provide informed consent 7. Able to understand study procedures and participate in study activities

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes 2. Insulin therapy 3. Pregnancy 4. Significant comorbidity or cognitive impairment 5. Previous use of personal CGM 6. Inability to provide informed consent

Design outcomes

Primary

Measure	Time frame
Recruitment rate measured using the number and proportion of eligible participants recruited into the study at throughout the recruitment period and assessed at study completion;Study completion rate measured using the number and proportion of participants completing all study procedures and follow-up assessments, assessed at study completion;Adherence to CGM use measured using the number and proportion of participants completing the planned CGM wear period(s) as recorded by FreeStyle Libre sensor data, at at Day 15 and Day 30 (intervention group only);Participant-reported acceptability of CGM-supported education measured using a study-specific questionnaire and/or semi-structured interview at completion of CGM monitoring (Day 15 for the self-directed CGM education group and Day 30 for the clinician-facilitated CGM education group)	—

Measure

Time frame

Recruitment rate measured using the number and proportion of eligible participants recruited into the study at throughout the recruitment period and assessed at study completion;Study completion rate measured using the number and proportion of participants completing all study procedures and follow-up assessments, assessed at study completion;Adherence to CGM use measured using the number and proportion of participants completing the planned CGM wear period(s) as recorded by FreeStyle Libre sensor data, at at Day 15 and Day 30 (intervention group only);Participant-reported acceptability of CGM-supported education measured using a study-specific questionnaire and/or semi-structured interview at completion of CGM monitoring (Day 15 for the self-directed CGM education group and Day 30 for the clinician-facilitated CGM education group)

—

Secondary

Measure	Time frame
Time in target glucose range measured using FreeStyle Libre CGM data at Day 15 and Day 30 (intervention group only);Mean glucose level measured using CGM data at Day 15 and Day 30 (intervention group only);Participant confidence in diabetes self-management measured using a study-specific questionnaire at completion of CGM monitoring (Day 15 for the self-directed CGM education group and Day 30 for the clinician-facilitated CGM education group)	—

Measure

Time frame

Time in target glucose range measured using FreeStyle Libre CGM data at Day 15 and Day 30 (intervention group only);Mean glucose level measured using CGM data at Day 15 and Day 30 (intervention group only);Participant confidence in diabetes self-management measured using a study-specific questionnaire at completion of CGM monitoring (Day 15 for the self-directed CGM education group and Day 30 for the clinician-facilitated CGM education group)

—

Countries

England, United Kingdom

Contacts

Public ContactNkiruka Ofokansi

nikki.ofokansi@nhs.net+44 (0)2037640664

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 25, 2026