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

ISRCTN	ISRCTN13277803
DOI	https://doi.org/10.1186/ISRCTN13277803
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	STUDY DT1/RD3
Sponsor	University Clinic of Kinshasa
Funder	Investigator initiated and funded

Submission date: 18/04/2024
Registration date: 16/05/2024
Last edited: 16/05/2024

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
In the Democratic Republic of Congo (DRC), it's common for children with Type 1 diabetes to develop a condition called diabetic retinopathy (DR), which affects the eyes. However, we've found that by educating patients about managing their condition and using continuous glucose monitoring systems (CGM) that measure glucose levels under the skin, we can decrease the occurrence of DR in these children in the DRC.

Who can participate?
This study includes children with Type 1 diabetes, with or without DR, from different diabetes clinics in Kinshasa managed by the Diocesan Medical Works Office (BDOM).

What does the study involve?
This research compares various aspects of health, including biological markers, eye health, and overall physical well-being, as well as the effectiveness of managing Type 1 diabetes and the advancement of diabetic retinopathy (DR) in two groups of children. One group uses a continuous glucose monitoring system (CGM), specifically the Dexcom one, while the other group monitors their blood glucose levels through self-testing.

What are the possible benefits and risks of participating?
During the study, all necessary monitoring equipment will be provided. They also get free medical tests and eye check-ups. They will receive guidance on managing their condition through patient therapeutic education.

Where is the study run from?
University Clinic of Kinshasa (Democratic Republic of Congo)

When is the study starting and how long is it expected to run for?
October 2023 to December 2025

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Christophe NTALU, ntachristophe1@gmail.com

Contact information

Prof Celestin NSIBU
Public, Scientific

Pediatric Departement
University Clinic of Kinshasa
Faculté de Médecine de Kinshasha
Kinshasa
-
Congo, Democratic Republic

Phone	+243 999 923 676
Email	celensibu@gmail.com

Prof Moïse MVITU
Scientific

Opthalmology Service
University Clinic of Kinshasa
kinshasa
-
Congo, Democratic Republic

Phone	+243 815 107 626
Email	moisemvitu2001@gmail.com

Prof Jean Robert MAKULO RISSASSI
Scientific

Medecine Departement
University Clinic of Kinshasa
kinshasa
-
Congo, Democratic Republic

Phone	+243990 205 367
Email	jrmakulo2016@gmail.com

Prof Marie claire MUYER
Scientific

University Clinic of Kinshasa
Kinshasa
-
Congo, Democratic Republic

Phone	+243 811 452 711
Email	muel-telo@yahoo.fr

Prof Georges MVUMBI LELO
Scientific

University of Kinshasa
Faculty of Medecine
kinshasa
-
Congo, Democratic Republic

Email	mvumbilelo@yahoo.fr

Dr Christophe NTALU
Principal investigator

Pediatric Department
University Clinic of Kinshasa
kinshasa
-
Congo, Democratic Republic

ORCID ID	0009-0005-3925-9559
Phone	+33 6 85 36 80 63
Email	christophe.ntalu@ch-stdenis.fr

Prof Adolphine NKUADIOLANDU
Scientific

Pediatric Department
University Clinic of Kinshasa
Kinshasa
-
Congo, Democratic Republic

Phone	+243 844 297 614
Email	nkuadiolandu@gmail.com

Study information

Primary study design	Interventional
Study design	Multicenter interventional randomized control trial
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	Type 1 diabetes in children and diabetic retinopathy in the Congolese environment: clinical, therapeutic and preventive approach
Study objectives	The use of continuous glucose monitoring (CGM) sensors can improve diabetes management and the progression of microangiopathic complications (diabetic retinopathy) in children with type 1 diabetes in the city of Kinshasa in the Democratic Republic of the Congo
Ethics approval(s)	Approved 25/10/2023, National Health Ethics comimittee of Democratic Republic of Congo (PNMLS Building, local 5 Kasa vubu, Kinshasa, -, Congo, Democratic Republic; +243 99 84 19 816; feli1munday@yahoo.fr), ref: 490/CNES/BN/PMMF/2023
Health condition(s) or problem(s) studied	Type 1 diabetes, diabetic retinopathy
Intervention	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 Dexcom one sensor for glycemic control, measuring interstitial glucose, while group 2 utilized fingerstick glycemic control, measuring capillary glucose. Biological parameters (HbA1c and microalbuminuria) were followed up at months 1, 3, 6, 9, and 12, and diabetic retinopathy stage was assessed at months 1 and 12.
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Dexcom ONE sensor
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2025

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	5 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	1000
Key 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
Key exclusion criteria	1. Age over 18 years 2. Non-type1 diabetes millitus 3. Non-consent
Date of first enrolment	04/03/2024
Date of final enrolment	30/12/2024

Locations

Countries of recruitment

Congo, Democratic Republic

Study participating centre

The six diabetic clinics of the city of Kinshasa (RDC)

Kinshasa
-
Congo, Democratic Republic

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	Data sharing plans for the ongoing study are currently unknown and will be available at later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

19/04/2024: Trial's existence confirmed by National Health Ethics comimittee of Democratic Republic of Congo.