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Diabetes in African Youth: Improving Glucose Time-In-Range

Award Number: R01DK126726
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2022
PERIOD OF PERFORMANCE END DATE: 03/31/2027

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Diabetes in African Youth: Improving Glucose Time-In-Range - ABSTRACT Despite major improvements, significant disparities in healthcare and outcomes exist in type 1 diabetes (T1D) in low vs high income countries. In our recent study of 68 African youth with T1D, patients were treated and educated by trained pediatric endocrinologists, performed self-monitoring of blood glucose (SMBG) an average of 2.1x/day, and had access to sufficient quantities of insulin. Average HbA1c was 11%. Blinded continuous glucose monitoring (CGM) demonstrated extremes of both hyper- and hypoglycemia. Glucose percent time-in- range (TIR, 70-180 mg/dl) was only 30%, and time-in-hypoglycemia (glucose <54 mg/dl) was 7%, with more than 80% of subjects spending ~ 2 hours a day hypoglycemic. Current practices are failing these children, who are at very high risk for diabetes acute and chronic complications. This RCT aims to improve T1D care in East African youth age 4-26 years by testing the hypothesis that enabling patients to continuously monitor glucose levels with flash CGM will improve glucose TIR, and that this therapy will be cost effective in the setting of a low-resource country. All subjects will receive identical monthly diabetes education. For the first 6 months, half of patients (n=90) will be given unblinded flash CGM so they can see their glucose levels in real time, while half (n=90, the control group) will perform ≥3x daily self-monitoring of blood glucose by fingerpoke (SMBG) while wearing a blinded CGM for endpoint measurement. The primary outcome measure, TIR, is assessed at 6 months. After 6 months, the unblinded CGM cohort will continue on this treatment for another 6 months to assess the impact of 1 year of unblinded CGM therapy. The control group will switch to unblinded CGM months 6-12. All patients in this study, including those in the control group, will receive more intensive education, greater attention from the diabetes team, and more test strips than are commonly available today. If this approach results in similar levels of improvement in glucose TIR in control subjects compared to patients who also receive CGM, this study will have performed an important service by demonstrating that there is no need for CGM therapy and that more focus, instead, needs to be placed on patient education and interaction with the medical team. But if CGM leads to significantly greater improvement in diabetes metabolic control by reducing hyper-and hypoglycemia, then the ethical question is not whether to provide this therapy in resource poor settings, but how to make it affordable. Such decisions must be guided by data obtained from children in the specific and unique settings found in low income nations. The goal of this protocol is to obtain these data.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $563,349 )
2026	2026	REGENTS OF THE UNIVERSITY OF MINNESOTA	2221 UNIVERSITY AVE SE STE 100	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	5	3/10/2026	SUPPLEMENT FOR EXPANSION	$271,939
2026	2026	REGENTS OF THE UNIVERSITY OF MINNESOTA	2221 UNIVERSITY AVE SE STE 100	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	3/4/2026	NON-COMPETING CONTINUATION	$291,410
														Subtotal = $563,349

Issue Date FY: 2025 ( Subtotal = $569,954 )
2025	2025	REGENTS OF THE UNIVERSITY OF MINNESOTA	2221 UNIVERSITY AVE SE STE 100	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	8/6/2025	NON-COMPETING CONTINUATION	$318,233
2025	2025	REGENTS OF THE UNIVERSITY OF MINNESOTA	2221 UNIVERSITY AVE SE STE 100	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	8/8/2025	SUPPLEMENT FOR EXPANSION	$251,721
														Subtotal = $569,954

Issue Date FY: 2024 ( Subtotal = $545,309 )
2024	2024	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	3/21/2024	NON-COMPETING CONTINUATION	$511,227
2024	2024	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	3	5/22/2024	NON-COMPETING CONTINUATION	$34,082
2024	2022	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	10/26/2023	NEW	$0
														Subtotal = $545,309

Issue Date FY: 2023 ( Subtotal = $569,125 )
2023	2023	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	4/17/2023	NON-COMPETING CONTINUATION	$569,125
														Subtotal = $569,125

Issue Date FY: 2022 ( Subtotal = $596,683 )
2022	2022	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	2/7/2022	NEW	$596,683
														Subtotal = $596,683

Grand Total All Awards = $2,844,420

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Diabetes in African Youth: Improving Glucose Time-In-Range

Award Number: R01DK126726

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/01/2022

PERIOD OF PERFORMANCE END DATE: 03/31/2027

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