Clinical Trials
Several clinical trials evaluate conditions including type 1 diabetes with emotional distress, type 2 diabetes, and thyroid cancer across observational, behavioral, and diagnostic frameworks with unassigned or non-applicable phases. Academic medical centers—including the University of North Carolina Chapel Hill and University Hospitals Cleveland Medical Center—and industry partners such as Insulet Corporation and DexCom Inc. sponsor these studies. Recruitment statuses range from not yet recruiting to completed trials assessing automated insulin delivery systems and continuous glucose monitoring devices.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06405386 | Not yet recruiting | Diabetes type1|Diabetes Mellitus Type 1|Diabetes Autoimmune|Diabetes Mellitus|Distress Emotional |
University of North Carolina Chapel Hill|American Diabetes Association |
2024-05 | Not Applicable |
| NCT06405373 | Not yet recruiting | Diabetes type1|Diabetes Mellitus Type 1|Diabetes Autoimmune|Diabetes Mellitus|Distress Emotional |
University of North Carolina Chapel Hill|American Diabetes Association |
2024-05 | Not Applicable |
| NCT05815342 | Completed | Type2 Diabetes |
Insulet Corporation|Jaeb Center for Health Research |
2023-04-11 | Not Applicable |
| NCT05523362 | Completed | Type 2 Diabetes |
Ian J. Neeland MD|DexCom Inc.|University Hospitals Cleveland Medical Center |
2022-01-15 | Not Applicable |
| NCT04821336 | Completed | Thyroid Cancer |
Institut Claudius Regaud|Cancer Research Center of Toulouse |
2021-04-15 | -- |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Compliance for Clinical Use
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
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