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

Type 1 diabetes in children and diabetic retinopathy in the Congolese environment: clinical, therapeutic and preventive approach

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13277803
Enrollment
1000
Registered
2024-05-16
Start date
2024-03-04
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Type 1 diabetes, diabetic retinopathy Nutritional, Metabolic, Endocrine

Interventions

We sampled type 1 diabetic patients aged 5 to 18 years with early-stage diabetic retinopathy. After 1:3 randomization, two groups were formed: group 1 used continuous glucose monitoring (CGM) with Dex

Sponsors

University Clinic of Kinshasa
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. Hb1Ac levels measured using the Siemens DCA VANTAGE analyzer at months 1, 3, 6, 9, and 12 2. Microalbuminuria measured using the Siemens DCA VANTAGE analyzer at months 1, 3, 6, 9, and 12 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

Secondary

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

Countries

Congo, Democratic Republic

Contacts

Public ContactCelestin NSIBU
celensibu@gmail.com+243 999 923 676

Outcome results

None listed

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