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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Vernon
Chinchilli
+1 (0)717 531 7178
vchinchi@psu.edu
Ms
Venus
Grella
+1 (0)717 531 0003, Ext 343413
vgrella@pennstatehealth.psu.edu
Dr
Abid
Kazi
+1 (0)717 531 0003, Ext 320036
akazi@pennstatehealth.psu.edu
Dr
Elizabeth
Seaquist
+1 (0)612 625 3654
seaqu001@umn.edu
Dr
Simon
Heller
+44 (0)114 215 9009
s.heller@sheffield.ac.uk
Type 1 diabetes with impaired awareness of hypoglycemia
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
People with type 1 diabetes (T1D) are at risk of complications that can be minimized by maintaining normal blood glucose levels. Of particular concern to people with T1D is hypoglycemia, in which blood glucose levels drop below normal and can lead to sweating, confusion, excessive hunger and in some cases, coma. On average, a person with T1D has two episodes of hypoglycemia per week and one or more episodes per year of severe hypoglycemia, defined as requiring third-party assistance. In addition, a person who has experienced repeated hypoglycemic events over the years is at risk of becoming less aware of the oncoming symptoms, which places the person at greater risk. This phenomenon is called impaired awareness of hypoglycemia (IAH) and affects 20-25% of individuals with T1D. Therefore, this study aims to compare hybrid closed loop (HCL) devices with psycho-educational programs to determine which can reduce the occurrence of IAH events. An HCL system, also known as an artificial pancreas, consists of a continuous glucose monitor (CGM), an insulin pump, and an algorithm that automatically manages insulin delivery.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Medical conditions that limit participation in study activities, as determined by the PI (including but not limited to cognitive dysfunction, reduced hearing, reduced vision, cancer under active treatment, untreated angina, and organ failure)2. Active alcohol or drug abuse, as defined by DSM criteria of either2.1. Recurrent use of alcohol/drugs resulting in a failure to fulfil major role obligations at work, school, or home2.2. Recurrent alcohol/drug use in situations in which it is physically hazardous, or2.3. Recurrent alcohol or drug-related legal problems4. Social determinants of health that limit participation in study activities, as determined by the PI (including but not limited to homelessness, food insecurity, and inadequate social support)5. Seizure disorder unrelated to hypoglycemia-associated seizures, unless documented seizure-free for >12 months and on a stable regimen of anticonvulsant therapy6. Skin conditions that would preclude the use of a CGM7. Super-physiologic exposure to steroids within one month of enrollment8. eGFR <45 ml/min/1.73 m29. History of bariatric surgery that irreversibly alters gut innervation and structure10. Hyper- or hypokalemia (serum potassium >5.5 or <3.5 mmol/L)*11. Hemoglobin <10 g/dL*12. Medical condition that requires intermittent or continuous use of glucocorticoids at greater than physiological replacement doses13. Pregnancy, plan for pregnancy, or breastfeeding14. Abnormal thyroid function tests of clinical significance, as determined by PI*15. Liver transaminases >3 times the upper limit of normal*16. Hospitalization for mental illness in the last year17. History of adrenalectomy* At the discretion of the PI, laboratory tests may be repeated once. If the participant is not eligible after the second attempt, then the participant may be screened again.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Abid
Kazi
+1 (0)717 531 0003, Ext 320036
akazi@pennstatehealth.psu.edu
Dr
Simon
Heller
+44 (0)114 215 9009
s.heller@sheffield.ac.uk
Dr
Elizabeth
Seaquist
+1 (0)612 625 3654
seaqu001@umn.edu
Ms
Venus
Grella
+1 (0)717 531 0003, Ext 343413
vgrella@pennstatehealth.psu.edu
Dr
Vernon
Chinchilli
+1 (0)717 531 7178
vchinchi@psu.edu
The study is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases and funded by National Institute of Diabetes and Digestive and Kidney Diseases.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 63897
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
