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DESMOND (Diabetes Education and Self Management for Ongoing and Newly Diagnosed) Ongoing Study

Not Applicable
Completed
Conditions
Type 2 diabetes mellitus (T2DM)
Nutritional, Metabolic, Endocrine
Non-insulin-dependent diabetes mellitus
Registration Number
ISRCTN71467886
Lead Sponsor
niversity of Leicester (UK)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
532
Inclusion Criteria

Current participant inclusion criteria as of 04/02/2019:
1. Individuals with established Type 2 Diabetes Mellitus
2. Diabetes duration of 12 months or more
3. HbA1c between 7.8 and 11%

Previous participant inclusion criteria:
1. Individuals with established Type 2 Diabetes Mellitus
2. Diabetes duration of 12 months or more
3. HbA1c between 7.0 and 11%

Exclusion Criteria

1. Receiving insulin therapy
2. Have existing comorbidities that could interfere with participation in the study over the 24 months
3. Unable to give informed consent
4. Severe and enduring mental health problems
5. Patients who are not primarily responsible for their own care
6. Unable to participate in a group programme (e.g. housebound)
7. Insufficient understanding of English to participate in the group education
8. Visually impaired or hard of hearing to the level that they can not participate in the group education
9. Aged under 18 years

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Reduction in HbA1c at 24 months
Secondary Outcome Measures
NameTimeMethod
<br> 1. Reduction in the following biomedical measures measured at 12 and 24 months<br> 1.1. HbA1c (at 12 months)<br> 1.2. Cholesterol (total, HDL and LDL)<br> 1.3. Triglyceride<br> 1.4. Blood pressure (BP) Systolic<br> 1.5. BP Diastolic<br> 1.6. Weight<br> 1.7. Waist circumference<br> 1.8. Hip circumference<br><br> 2. Improvement in the following scores at 12 and 24 months<br> 2.1. EQ5D<br> 2.2. Illness Perceptions Questionnaire revised<br> 2.3. Diabetes Illness Representations Questionnaire<br> 2.4. Summary of Diabetes Self Care Activities questionnaire<br> 2.5. Hospital Anxiety and Depression Score<br> 2.6. Problem Areas in Diabetes Score<br> 2.7. International Physical Activity Questionnaire<br>
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