Diabetes Mellitus, Type 1 Clinical Trial
Official title:
An Observational Study of Individuals With Type 1 Diabetes Using the Loop System for Automated Insulin Delivery
An observational study to collect data on the efficacy, safety, usability, and quality of life/psychosocial effects of the Loop DIY automated insulin delivery system.
The study will include both adults and youth in the United States, with a recruitment goal of
at least 300-1,250 participants. Data to be collected to address the study objective will
include CGM metrics; HbA1c; insulin delivery data; carbohydrate data; activity data from
HealthKit; self-reported adverse events (e.g., severe hypoglycemia, diabetic ketoacidosis,
hospitalizations); self-reported device issues; and psychosocial and user
experience/treatment satisfaction surveys.
Online forms will allow participants to report weekly device issues and serious adverse
events including severe hypoglycemia, diabetic ketoacidosis, and hospitalizations. General
data updates will be obtained after three, six, and 12 months (and every six months
thereafter if study participation continues). A fingerstick blood sample will be collected
for HbA1c measurement after three months for cohort A and after six and 12 months for both
cohorts. Quality-of-life/psychosocial and treatment satisfaction questionnaires will be
completed after six and 12 months; new users also will complete questionnaires after 3
months. Virtual focus groups will be completed within the first three months of starting Loop
and at 12 months.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
| Terminated |
NCT03605329 -
Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS
|
N/A | |
| Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
| Recruiting |
NCT06050642 -
Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.
|
N/A | |
| Completed |
NCT05107544 -
Metabolic, Physical Fitness and Mental Health Effects of High Intensity Interval Training (HIIT) in Adolescents With Type 1 Diabetes
|
N/A | |
| Active, not recruiting |
NCT04443153 -
Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes
|
N/A | |
| Completed |
NCT04521634 -
Glycaemic Variability in Acute Stroke
|
||
| Completed |
NCT04569994 -
A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes
|
Phase 1 | |
| Completed |
NCT04089462 -
Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study
|
N/A | |
| Completed |
NCT03143816 -
Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study
|
Phase 4 | |
| Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
| Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A | |
| Completed |
NCT04042207 -
Diabeloop for Highly Unstable Type 1 Diabetes
|
N/A | |
| Not yet recruiting |
NCT06068205 -
COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
|
||
| Recruiting |
NCT05909800 -
Prolonged Remission Induced by Phenofibrate in Children Newly Diagnosed With Type 1 Diabetes.
|
Phase 2 | |
| Active, not recruiting |
NCT04974528 -
Afrezza® INHALE-1 Study in Pediatrics
|
Phase 3 | |
| Completed |
NCT04530292 -
Home Intervention and Social Precariousness in Childhood Diabetes
|
N/A | |
| Completed |
NCT05428943 -
OPT101 in Type 1 Diabetes Patients
|
Phase 1 | |
| Recruiting |
NCT03988764 -
Monogenic Diabetes Misdiagnosed as Type 1
|
||
| Completed |
NCT05597605 -
The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects
|
N/A |