Jaeb Center For Health Research Inc

DESIGN AND CONDUCT WORLD-CLASS CLINICAL TRIALS AND EPIDEMIOLOGIC RESEARCH.

SEE SCHEDULE O DURING 2023, JCHR WAS ENGAGED IN 53 CLINICAL STUDIES. THESE STUDIES RESULTED IN 42 SCIENTIFIC PUBLICATIONS AND 59 PRESENTATIONS AT NATIONAL AND INTERNATIONAL MEETINGS.IN 2023, JCHR RECEIVED GRANTS FROM THE NATIONAL INSTITUTES OF HEALTH (8), HELMSLEY CHARITABLE TRUST (8), JDRF (6), FOUNDATION FIGHTING BLINDNESS (5), CYSTIC FIBROSIS FOUNDATION (4), AND FOOD AND DRUG ADMINISTRATION (1). COLLABORATIONS WITH INDUSTRY CONTINUE TO FORM AN INTEGRAL PART OF OUR BUSINESS. JCHR WAS ENGAGED IN STRATEGIC COLLABORATIONS WITH 10 INDUSTRY PARTNERS IN 2023. THESE COLLABORATIONS SPANNED 15 STUDIES. SEVERAL STUDIES ARE FUNDED BY MULTIPLE SOURCES. FOR EXAMPLE, ONE CLINICAL TRIAL EVALUATING FENOFIBRATE FOR DIABETIC RETINOPATHY IS A LARGE COLLABORATION WITH FUNDS PROVIDED BY THE NATIONAL INSTITUTES OF HEALTH (NATIONAL EYE INSTITUTE AND NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASE), JDRF, HELMSLEY CHARITABLE TRUST, AND ROCHE. JCHR ALSO SELF-FUNDED TWO STUDIES AND NUMEROUS STATISTICAL ANALYSIS PROJECTS USING DATASETS FROM PREVIOUSLY COMPLETED STUDIES. AMONG 2,894 ENTITIES RECEIVING NIH FUNDING IN 2023, JCHR RANKS IN THE TOP 8 PERCENT. OUT OF 66,149 NIH GRANTS PROVIDED IN 2023, JCHR HAD THE 136TH- (TOP 0.2 PERCENT) AND 210TH- (TOP 0.3 PERCENT) LARGEST GRANTS (SOURCE: BLUE RIDGE INSTITUTE FOR MEDICAL RESEARCH, 2023).IN 2023, THE JCHR COORDINATED RANDOMIZED TRIAL OF A BIONIC PANCREAS IN INDIVIDUALS WITH TYPE 1 DIABETES LEAD TO FDA 510(K) CLEARANCE FOR THE BETA BIONICS ILET BIONIC PANCREAS. IN ADDITION, RESULTS FROM THE DEXCOM SPONSORED MOBILE STUDY (COORDINATED BY JCHR) SERVED AS THE PRIMARY PIECE OF CLINICAL EVIDENCE THAT LED TO MEDICARE COVERAGE EXPANSION FOR CONTINUOUS GLUCOSE MONITORS, PROVIDING COVERAGE TO PEOPLE WITH DIABETES USING INSULIN, IRRESPECTIVE OF DIABETES TYPE.RESULTS FROM JCHR-AUTHORED MANUSCRIPTS INCLUDE THE FOLLOWING TWO THAT WERE PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE AND THREE PUBLISHED IN JAMA:A STUDY INVOLVING PREGNANT WOMEN WITH TYPE 1 DIABETES COMPARED THE EFFECTIVENESS OF STANDARD INSULIN THERAPY TO HYBRID CLOSED-LOOP THERAPY, WHICH USES CONTINUOUS GLUCOSE MONITORING. THE RESULTS SHOWED THAT THE CLOSED-LOOP THERAPY GROUP HAD SIGNIFICANTLY BETTER GLYCEMIC CONTROL DURING PREGNANCY COMPARED WITH THE STANDARD-CARE GROUP, WITH FEWER INSTANCES OF HYPERGLYCEMIA AND IMPROVED OVERNIGHT GLUCOSE LEVELS, INDICATING THE POTENTIAL BENEFITS OF THIS APPROACH FOR MANAGING TYPE 1 DIABETES DURING PREGNANCY.IN A 13-WEEK TRIAL INVOLVING YOUNG CHILDREN (AGED 2 TO UNDER 6 YEARS) WITH TYPE 1 DIABETES, A CLOSED-LOOP SYSTEM OF INSULIN DELIVERY WAS COMPARED WITH STANDARD CARE USING EITHER AN INSULIN PUMP OR MULTIPLE DAILY INJECTIONS WITH A CONTINUOUS GLUCOSE MONITOR. RESULTS SHOWED THAT CHILDREN USING THE CLOSED-LOOP SYSTEM SPENT SIGNIFICANTLY MORE TIME WITHIN THE TARGET RANGE COMPARED WITH THOSE IN THE STANDARD-CARE GROUP.IN A DOUBLE-BLIND, RANDOMIZED CLINICAL TRIAL INVOLVING CHILDREN AND ADOLESCENTS NEWLY DIAGNOSED WITH TYPE 1 DIABETES, THE EFFECTS OF VERAPAMIL, A CALCIUM CHANNEL BLOCKER, WERE INVESTIGATED ON PANCREATIC BETA CELL FUNCTION. PARTICIPANTS RECEIVING VERAPAMIL DEMONSTRATED A 30 PERCENT HIGHER C-PEPTIDE LEVEL AT 52 WEEKS COMPARED WITH THOSE ON A PLACEBO, INDICATING PARTIAL PRESERVATION OF PANCREATIC BETA CELL FUNCTION. FURTHER STUDIES ARE NEEDED TO ASSESS THE LONG-TERM DURABILITY OF C-PEPTIDE IMPROVEMENT AND DETERMINE THE OPTIMAL DURATION OF THERAPY. IN A RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL INVOLVING YOUTH WITH NEWLY DIAGNOSED TYPE 1 DIABETES, INTENSIVE DIABETES MANAGEMENT, INCLUDING THE USE OF AN AUTOMATED INSULIN DELIVERY SYSTEM, WAS COMPARED TO STANDARD CARE. THE STUDY AIMED TO DETERMINE IF ACHIEVING NEAR NORMALIZATION OF GLUCOSE LEVELS IMMEDIATELY AFTER DIAGNOSIS COULD PRESERVE PANCREATIC BETA CELL FUNCTION. DESPITE ACHIEVING EXCELLENT GLUCOSE CONTROL, THE INTENSIVE MANAGEMENT GROUP DID NOT SHOW A SIGNIFICANT DIFFERENCE IN PANCREATIC C-PEPTIDE SECRETION DECLINE AT 52 WEEKS COMPARED TO THE STANDARD CARE GROUP, SUGGESTING THAT THIS APPROACH DID NOT IMPACT THE PRESERVATION OF BETA CELL FUNCTION IN THE STUDIED POPULATION.A STUDY COMPARING INTRAVITREAL AFLIBERCEPT TREATMENT TO A SHAM PROCEDURE IN INDIVIDUALS WITH MODERATE TO SEVERE NONPROLIFERATIVE DIABETIC RETINOPATHY (NPDR) WITHOUT CENTER-INVOLVED DIABETIC MACULAR EDEMA (CI-DME) REVEALED THAT OVER FOUR YEARS, AFLIBERCEPT SIGNIFICANTLY REDUCED THE LIKELIHOOD OF DEVELOPING VISION-THREATENING COMPLICATIONS COMPARED TO THE SHAM PROCEDURE. HOWEVER, DESPITE ANATOMICAL IMPROVEMENT, THERE WAS NO SIGNIFICANT DIFFERENCE IN VISUAL ACUITY BETWEEN THE TWO GROUPS. THE STUDY SUGGESTS THAT USING AFLIBERCEPT PREVENTIVELY IN PATIENTS WITH NPDR WITHOUT CI-DME MAY NOT BE GENERALLY NECESSARY BASED ON THE OBSERVED OUTCOMES.JCHR'S INVOLVEMENT IN DIABETES STUDIES CONTINUES TO EXPAND AS IT SOLIDIFIED ITS REPUTATION AS THE PREMIERE COORDINATING CENTER WORLDWIDE FOR DIABETES DEVICE STUDIES.