Type 2 diabetes self-management using continuous glucose monitoring

A randomised, controlled crossover study of short-term use of continuous glucose monitoring (CGM) to support self-management behaviour in complex type 2 diabetes mellitus: the DISCO GM study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17386990

Enrollment

Registered

2021-04-22

Start date

2021-06-21

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Self-management of type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

The study will be a randomised controlled crossover study of 36 weeks duration comparing: 1. Routine diabetes care plus diabetes self-management education 2. Short term use of Continuous Glucose Monit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years 2. Diagnosed with Type 2 Diabetes for over 1 year 3. Receiving care from a specialist diabetes team (hospital outpatient setting) 4. HbA1c level equal to or over 75 mmol/mol (9%) 5. Willing and able to provide informed consent 6. Willing and able to engage with continuous glucose monitoring

Exclusion criteria

Exclusion criteria: 1. Diabetes other than Type 2 Diabetes 2. Pregnancy 3. Participation in any investigational drug trial within one month prior to visit 1 4. Condition rendering the participant unable to understand the nature, scope, and possible consequences of the study 5. End-stage renal disease (existing or planned dialysis or transplantation) 6. Severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, and diabetic macular oedema 7. Blindness or severe loss of visual acuity in both eyes 8. Treatment with hydroxyurea 9. Treatment with paracetamol (acetaminophen) higher than 1,000 mg every 6 h daily

Design outcomes

Primary

Measure	Time frame
Diabetes self-management behaviour will be measured using the Diabetes Self-Management Questionnaire (DSMQ) at randomisation, 12, 24, and 36 weeks.	—

Secondary

Measure	Time frame
1. Diabetes-related quality of life measured using the Audit of Diabetes Dependent Quality of Life (ADDQoL) questionnaire at randomisation, 12, 24, and 36 weeks 2. Diabetes related distress measured using the Problem Areas in Diabetes (PAID-5) questionnaire at randomisation, 12, 24, and 36 weeks. 3. Patient Activation Level measured using the Patient Activation Measure (PAM) at screening, randomisation, 12, 24, and 36 weeks 4. Blood glucose control measured using HbA1c at randomisation, 12, 24, and 36 weeks 5. Glucose variability, incidence of hypoglycaemia, and time in range metrics will be measured using the continuous glucose monitoring device during the 12 week period the participant wears the device 6. Clinical outcomes such as weight, BMI, waist circumference and total cholesterol will be measured at randomisation, 12, 24 and 36 weeks	—

Measure

Time frame

1. Diabetes-related quality of life measured using the Audit of Diabetes Dependent Quality of Life (ADDQoL) questionnaire at randomisation, 12, 24, and 36 weeks 2. Diabetes related distress measured using the Problem Areas in Diabetes (PAID-5) questionnaire at randomisation, 12, 24, and 36 weeks. 3. Patient Activation Level measured using the Patient Activation Measure (PAM) at screening, randomisation, 12, 24, and 36 weeks 4. Blood glucose control measured using HbA1c at randomisation, 12, 24, and 36 weeks 5. Glucose variability, incidence of hypoglycaemia, and time in range metrics will be measured using the continuous glucose monitoring device during the 12 week period the participant wears the device 6. Clinical outcomes such as weight, BMI, waist circumference and total cholesterol will be measured at randomisation, 12, 24 and 36 weeks

—

Countries

United Kingdom, Wales

Contacts

Public ContactSharon Parsons

S.N.Parsons@Swansea.ac.uk+44 (0)1792 606721

Outcome results

None listed

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