Type 1 diabetes monitoring and ophthalmic complications in children in the Democratic Républic of Congo

Not Applicable

• Conditions: Type 1 diabetes, diabetic retinopathy; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN13277803
• Lead Sponsor: niversity Clinic of Kinshasa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-16
• Last Update Posted: 27 May 2024
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Children under 18 years of age, of both sexes, followed in the six diabetic clinics in Kinshasa
2. Known diabetic with diabetic retinopathy
3. No-sickle cell children
4. Informed consent from parents

Exclusion Criteria

1. Age over 18 years
2. Non-type1 diabetes millitus
3. Non-consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Hb1Ac levels measured using the Siemens DCA VANTAGE analyzer at months 1, 3, 6, 9, and 12<br>2. Microalbuminuria measured using the Siemens DCA VANTAGE analyzer at months 1, 3, 6, 9, and 12<br>3. Stages of diabetic retinopathy measured using the 2016 standards for screening and surveillance of ocular complications in people with diabetes at months 1 and 12<br>

Secondary Outcome Measures

Name	Time	Method
1. Glycemic average measured using the following standard formula: Hb1ac (in %) x 1.59 - 2.59 at months 1, 3, 6, 9, and 12<br>2. Time in range (TIR) measured using a Dexcom ONE MCG sensor at months 1, 3, 6, 9, and 12<br>3. Body mass index (BMI) calculated by dividing weight in kg by height in cm squared at months 1, 3, 6, 9, and 12