Type 2 diabetes self-management using continuous glucose monitoring

Not Applicable

Completed

• Conditions: Self-management of type 2 diabetes; Nutritional, Metabolic, Endocrine; Type 2 diabetes mellitus

• Registration Number: ISRCTN17386990
• Lead Sponsor: Swansea University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-22
• Study Completion: 2023-03-31
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 62

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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<br>2. Diabetes related distress measured using the Problem Areas in Diabetes (PAID-5) questionnaire at randomisation, 12, 24, and 36 weeks.<br>3. Patient Activation Level measured using the Patient Activation Measure (PAM) at screening, randomisation, 12, 24, and 36 weeks<br>4. Blood glucose control measured using HbA1c at randomisation, 12, 24, and 36 weeks<br>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<br>6. Clinical outcomes such as weight, BMI, waist circumference and total cholesterol will be measured at randomisation, 12, 24 and 36 weeks