Is it safe to stop insulin injections in older adults with type 2 diabetes?

Safety and feasibility of insulin simplification or cessation in frail older adults with type 2 diabetes: a pilot study of CLASP (using C-peptide to clarify, simplify and personalise type 2 diabetes management in frail older adults)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN76893830

Enrollment

Registered

2024-12-12

Start date

2024-12-13

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Treatment of type 2 diabetes in older adults with frailty. Nutritional, Metabolic, Endocrine

Interventions

This is a small observational study where individuals found to have retained endogenous insulin secretion will have their insulin therapy gradually withdrawn while substituting with GLP-1 receptor ago

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient participants 1. Age 70 years old and above 2. Frailty - either care home residents, patients who require community nurse support to administer insulin, or has a clinical frailty score of 5 or above 3. Diagnosis of type 2 diabetes of more than 3 years 4. Current insulin prescription 5. HbA1c below 70mmol/mol 6. Random C-peptide level of 900pmol/L or above with paired serum glucose above 3.9mmol/L 7. BMI 25kg/m2 8. Has access to a smartphone or is willing to use one provided by the study team Healthcare professional participants Any general practitioners, community nurses or care home staff involved in the care of the participants and implementation of the study

Exclusion criteria

Exclusion criteria: 1. eGFR below or equal to 30ml/min/1.73m2 2. Current GLP-1 analogue prescription 3. Current oral corticosteroid prescription 4. Previous severe intolerance to GLP-1 analogue 5. Previous history of severe pancreatitis 6. History of medullary thyroid carcinoma, MEN-2 or family history of MEN-2 7. Active malignancy except basal cell or squamous cell carcinoma of the skin 8. If an individual is unable to consent

Design outcomes

Primary

Measure	Time frame
The percentage of patients stopping insulin measured using data collected in the study records at one timepoint	—

Secondary

Measure	Time frame
1. The following secondary outcome variables will be measured using data from medical records, case report forms and the continuous glucose monitor (CGM) device: 1.1. Hospital admissions with hyperosmotic hyperglycaemic state 1.2. Diabetes ketoacidosis or severe hypoglycaemia or ambulance call out for severe hypoglycaemia 1.3. Participant-reported hypoglycaemic episodes 1.4. The time below range on the CGM device 2. Participants' acceptability of stopping insulin, healthcare professionals or care home staff of insulin cessation pathway measured using data collected during semi-structured interviews at one timepoint	—

Measure

Time frame

1. The following secondary outcome variables will be measured using data from medical records, case report forms and the continuous glucose monitor (CGM) device: 1.1. Hospital admissions with hyperosmotic hyperglycaemic state 1.2. Diabetes ketoacidosis or severe hypoglycaemia or ambulance call out for severe hypoglycaemia 1.3. Participant-reported hypoglycaemic episodes 1.4. The time below range on the CGM device 2. Participants' acceptability of stopping insulin, healthcare professionals or care home staff of insulin cessation pathway measured using data collected during semi-structured interviews at one timepoint

—

Countries

Scotland, United Kingdom

Contacts

Public ContactEwan Pearson

E.Z.Pearson@dundee.ac.uk+44 1382660111

Outcome results

None listed

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