Diabetes in African Youth

Status Recruiting

Clinical Trial Summary

This RCT aims to improve T1D care in East African children and young adults by testing the hypothesis that enabling patients to continuously monitor glucose levels with flash CGM technology will improve glucose time-in-range (glucose level 70-180 mg/dl). A second primary endpoint is to perform a cost analysis on flash glucose monitoring compared to 3x/day SMBG, to determine whether this technology is cost-effective in the setting of a less-resourced nation. After a 2 week assessment with blinded CGM when a potential subject's ability to wear CGM is confirmed, subjects will be enrolled for 12 months in randomized, open label study, with a primary endpoint measurement at 6 months. All subjects will receive monthly diabetes self-management education. For the first six months, months 1-6: - Half of patients (n=90) will be randomized to an unblinded FreeStyle Libre 2 CGM.They and their care providers will be able to continuously see their CGM glucose levels to assist in insulin adjustment. - Half of patients (n=90) will be given sufficient test strips for 3x daily SMBG while wearing blinded CGM (control group). Neither they nor their care providers will be able to see their CGM glucose levels (the blinded CGM is simply for outcome measurement, not an intervention). As per usual clinical practice, only the SMBG glucose levels will be available to assist in insulin adjustment. - The change between baseline to 6 months in CGM-derived glucose percent time-in- range will be compared between groups (first primary study endpoint). For the second six months, months 7-12: - The control group will switch to unblinded CGM months 7-12 (their data months 7-12 months will be compared to their data months 1-6 as part of the primary endpoint assessment). - The patients who wore the unblinded CGM months 1-6 will continue for another 6 months to assess the impact of wearing the CGM for 12 continuous months (a secondary endpoint). Once the clinical portion of the study is complete, study investigators who are health economists from the Uganda Ministry of Health will perform a costs analysis (second primary endpoint).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05454176
Study type	Interventional
Source	University of Minnesota
Contact	Beth Pappenfus
Phone	612-624-2922
Email	papp0086@umn.edu
Status	Recruiting
Phase	Phase 4
Start date	August 15, 2022
Completion date	August 15, 2027

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03886974` - Transition to Adult Care in Type 1 Diabetes
Completed	`NCT05620251` - Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes
Completed	`NCT03623113` - The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes	N/A
Active, not recruiting	`NCT05078658` - Low-carbohydrate Diet in Children With Type 1 Diabetes	N/A
Not yet recruiting	`NCT06018324` - CloudCare in the Treatment of Type 1 Diabetes in Pediatrics
Withdrawn	`NCT03736083` - Introducing CGM at Type 1 Diabetes Diagnosis	N/A
Completed	`NCT03177096` - Impact of the Continuous Measurement of Blood Glucose on Insulin Pump on Child Quality of Life With Type 1 Diabetes	N/A
Not yet recruiting	`NCT06418269` - The Effect of Therapeutic Play on Anxiety and Fear Levels in Children With Diabetes	N/A
Completed	`NCT04172077` - Self Efficacy Levels, Attachment Style and Resiliency of Youth With Type 1 Diabetes
Recruiting	`NCT04950634` - Sexual Dimorphism in Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
Completed	`NCT04450745` - Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients	N/A
Completed	`NCT03165786` - A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With Type 1 Diabetes	N/A
Terminated	`NCT04028960` - IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase	Phase 2
Recruiting	`NCT05324488` - Diabetes Registry Graz for Biomarker Research
Completed	`NCT02984709` - Check It! 2.0: Positive Psychology Intervention for Adolescents With Type 1 Diabetes	N/A
Completed	`NCT02984514` - Brown Adipose Tissue in Type 1 Diabetes	N/A
Recruiting	`NCT06372392` - Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps	N/A
Recruiting	`NCT03311516` - New Insulin Therapy by Multiwave Bolus	N/A
Recruiting	`NCT05973799` - Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes	N/A
Completed	`NCT03711656` - Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes Using Machine Learning Techniques	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.