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Device

RT-CGM for Type 1 Diabetes

N/A

Waitlist Available

Led By Michael R Rickels, M.D., M.S.

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Study Summary

This trial is searching for a Hypo-AWARE Type 1 diabetic control group to compare against those with a continuous glucose monitor. The goal is to see if the monitor helps Type 1 diabetics become more aware of their blood sugar levels.

Eligible Conditions

Type 1 Diabetes
Hypoglycemia Unawareness
Healthy Subjects

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Autonomic Symptom Response to Hypoglycemia

Endogenous Glucose Production

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hypoglycemia Unaware T1 Diabetes RT-CGMExperimental Treatment1 Intervention

This arm is the intervention group. It consists of participants with type 1 diabetes complicated by hypoglycemia unawareness. Patients wore an RT-CGM for 18 months. We studied glucose production and symptom generation during insulin-induced hypoglycemia (metabolic testing) by subjecting this intervention group to a pair of metabolic clamps (hypoglycemic and euglycemic) at baseline, at 6 months and at 18 months to determine if hypoglycemia avoidance can reverse unawareness. Please note: Arms are not assigned to the two control groups (non-diabetics and T1Ds with intact awareness) in ct.gov as they are only used as a baseline for clinical significance. Neither group wore a CGM nor are they analyzed at 6-month and 18-month time-points.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RT-CGM

2011

N/A

~150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,880,051 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,357 Previous Clinical Trials

4,315,149 Total Patients Enrolled

Michael R Rickels, M.D., M.S.Principal InvestigatorUniversity of Pennsylvania

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is my eligibility sufficient to join the experiment?

"This clinical trial is enrolling 32 individuals, who must have type 1 diabetes mellitus and meet an age requirement of 25 to 70 years old."

Answered by AI

Does this experiment accept elderly individuals above the age of 70 as participants?

"This medical study requires that applicants are aged between 25 and 70, while 276 trials targeting individuals below the age of 18 and 1320 studies accommodating patients over 65 exist."

Answered by AI

Is there any availability to join the experiment?

"Evidently, this clinical trial is not currently enrolling patients as per the information hosted on clinicaltrials.gov. This particular study was posted on October 1st 2011 and modified most recently on May 16th 2022, yet 2140 alternative trials are still in need of participants at present."

Answered by AI

Recent research and studies

Diabetes/Metabolism Research and ReviewsJournal

Severe Hypoglycaemia in 1076 Adult Patients with Type 1 Diabetes: Influence of Risk Markers and Selection

Pedersen-Bjergaard, Ulrik, Stig Pramming, Simon R Heller, Tara M Wallace, Åse K Rasmussen, Hanne V Jørgensen, David R Matthews, Philip Hougaard, and Birger Thorsteinsson. 2004. “Severe Hypoglycaemia in 1076 Adult Patients with Type 1 Diabetes: Influence of Risk Markers and Selection”. Diabetes/metabolism Research and Reviews. Wiley. doi:10.1002/dmrr.482.

Diabetic MedicineJournal

Sensor-augmented Pump Therapy Lowers Hba1c in Suboptimally Controlled Type 1 Diabetes; a Randomized Controlled Trial

Hermanides, J., K. Nørgaard, D. Bruttomesso, C. Mathieu, A. Frid, C. M. Dayan, P. Diem, et al.. 2011. “Sensor-augmented Pump Therapy Lowers Hba1c in Suboptimally Controlled Type 1 Diabetes; a Randomized Controlled Trial”. Diabetic Medicine. Wiley. doi:10.1111/j.1464-5491.2011.03256.x.

DiabetesJournal

Islet Cell Hormonal Responses to Hypoglycemia After Human Islet Transplantation for Type 1 Diabetes

Rickels, Michael R., Mark H. Schutta, Rebecca Mueller, James F. Markmann, Clyde F. Barker, Ali Naji, and Karen L. Teff. 2005. “Islet Cell Hormonal Responses to Hypoglycemia After Human Islet Transplantation for Type 1 Diabetes”. Diabetes. American Diabetes Association. doi:10.2337/diabetes.54.11.3205.

DiabetesJournal