Insulin intervention development for people with type 2 diabetes

A mixed methods study to support insulin self-management for people with type 2 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13339678

Enrollment

Registered

2018-07-30

Start date

2019-03-01

Completion date

Unknown

Last updated

2023-06-26

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

Study 1: Interviews of approximately 30 patients with type 2 diabetes mellitus (T2DM) who receive treatment in the South London borough of Lambeth who have either attended an insulin start group, been

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Initial interviews and testing: 1. Diagnosis of type 2 diabetes 2. 18 years or over Randomized controlled feasibility study: 1. Diagnosis of type 2 diabetes 2. Aged 40-65 years 3. Identified by general practitioner as requiring insulin treatment, i.e. on maximum tolerated dose of 2 OADs and glycaemic control HbA1c >/=7.5% (58 mmols/mol) on two occasions

Exclusion criteria

Exclusion criteria: Initial interviews and testing: 1. Non-fluency in English 2. Severe mental illness Randomized controlled feasibility study: 1. Non-fluency in English 2. Morbid obesity (BMI >/=35) 3. In employment that contraindicates insulin treatment, e.g. HGV driver 4. Severe depression, anxiety disorders, psychotic disorders, or personality disorders, or cognitive impairment

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 12/06/2023: Self-reported attitudes towards insulin treatment, measured using the insulin treatment appraisal scale (ITAS) at baseline and 6 months Previous primary outcome measure: Self-reported acceptance of insulin, measured using the beliefs in insulin treatment (BIT) scale at baseline and 6 months	—

Secondary

Measure	Time frame
1. Self-reported use of insulin and diabetes medication measured using the visual analogue scale (VAS) at baseline and 6 months 2. Diabetes distress measured using the Problems Areas in Diabetes scale (PAID score) at baseline and 6 months 3. Depressive symptoms measured using the Patient Health Questionnaire 9 (PHQ-9) at baseline and 6 months 4. Weight (kg) measured at baseline and 6 months 5. Blood glycated haemoglobin HbA1c (mmol/mol) measured using high performance liquid chromatography (HPLC) standard assay at baseline and 6 months	—

Measure

Time frame

1. Self-reported use of insulin and diabetes medication measured using the visual analogue scale (VAS) at baseline and 6 months 2. Diabetes distress measured using the Problems Areas in Diabetes scale (PAID score) at baseline and 6 months 3. Depressive symptoms measured using the Patient Health Questionnaire 9 (PHQ-9) at baseline and 6 months 4. Weight (kg) measured at baseline and 6 months 5. Blood glycated haemoglobin HbA1c (mmol/mol) measured using high performance liquid chromatography (HPLC) standard assay at baseline and 6 months

—

Countries

England, United Kingdom

Outcome results

None listed

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