Safety and Efficacy of BC LisPram

• Status: Not yet recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This pilot study is a 50-hour randomized, open-label, crossover study in an inpatient setting assessing the safety, pharmacodynamics, pharmacokinetics, and closed-loop efficacy of i) BC LisPram delivery and ii) rapid insulin delivery.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Tsoukas
• Collaborator: Adocia
• Treatments: Insulin Lispro

Criteria

Inclusion Criteria:

• Males and females ≥ 18 years of age.

• Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.

• Insulin pump therapy for at least 3 months, with daily insulin needs ranging between 30 and 80 U.

• Most recent HbA1c ≤ 9.5% (over the last two months).

• Effective birth control in female participants of childbearing potential. Medically acceptable contraception methods include condom, pills, and intrauterine device.

Exclusion Criteria:

• Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2, GLP-1, Metformin, Acarbose, etc....).

• Current use of glucocorticoid medication.

• Use of medication that alters gastrointestinal motility.

• Planned or ongoing pregnancy.

• Breastfeeding individuals

• Severe hypoglycemic episode within one month of admission.

• Severe diabetic ketoacidosis episode within one month of admission.

• Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.

• Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.

• Known hypersensitivity to any of the study drugs or their excipients.

• Allergy to paracetamol (acetaminophen).

• Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

• Clinically abnormal significant values for haemato, biochemistry, or urinalysis screening test as judged by the Principle Investigator for underlying disease.

• Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).