The intelligent Diabetes Platform - iDiabetes

Not Applicable

• Conditions: Diabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN18000901
• Lead Sponsor: niversity of Dundee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-05
• Last Update Posted: 19 August 2024
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 22500

Inclusion Criteria

1. Registered patients with a diagnosis of diabetes
2. Age >18 years

Exclusion Criteria

Does not meet the inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A composite hierarchical outcome evaluated utilising the Win-Ratio statistical methodology. Composite composed of (in decreasing order of clinical importance): <br>1. All-cause mortality <br>2. All-cause hospitalisation rate <br>3. Proportion with >40% eGFR reduction from baseline, or new development of end-stage kidney disease (ESKD) <br>4. Proportion with absolute HbA1C reduction >0.5% (>5.5 mmol/mol)<br>All data is routine clinically collected data accessible in the Sci-Diabetes system and SMR01 at baseline and 2 years.

Secondary Outcome Measures

Name	Time	Method
1. All-cause mortality rate<br>2. All-cause hospitalisation rate <br>3. Proportion with >40% eGFR reduction from baseline, or new ESKD <br>4. Proportion with absolute HbA1C reduction >0.5% (>5.5 mmol/mol) <br>5. Hospitalisation rate secondary to heart failure<br>6. Drug adherence rate – frequency of prescription encashment of diabetes and cardiovascular drugs<br>7. Rate of severe hypoglycaemia – severe hypoglycaemic episodes requiring paramedic callout<br>8. Proportion of patients treated according to guidelines – prescription of diabetes drugs (compared to updated ADA/EASD guidelines)<br>All data is routine clinically collected data accessible in the Sci-Diabetes system and SMR01 at baseline and 2 years