ZONE: Effect of ZT-01 On Nocturnal hypoglycemia Events in type 1 diabetes mellitus

Summary

We are looking for people living with type 1 diabetes who have ongoing low blood sugar, particularly at night, but have otherwise stable diabetes management. Participants should not have frequent severe hypoglycemia or recent visits to the hospital because of diabetes problems.

This study will explore if a new medication, only available in a research study, can reduce nighttime low blood sugar events.

One of three drug doses will be compared to a placebo for each research participant to see if blood sugars are better managed overnight and throughout the day.

Total time in study is approximately 18 weeks (4.5 months). Study visits are conducted in the mornings at the Clinical Trials Unit at Richmond Road Diagnostic and Treatment Centre.

Eligibility

Currently recruiting participants: Yes

Eligible ages: 18 to 75

Inclusion criteria:

1) Adult living with Type 1 Diabetes for at least 5 years
2) Nighttime low blood sugar is a recurring issue (<3.0mmol/L bimonthly, or time-below-range ≥1% in an ambulatory glucose profile average over 28 days)
3) Stable diabetes management routine (diet and exercise, medications)
4) Not planning a pregnancy and agree to use highly effective birth control
5) Other clinically relevant markers of health must be reviewed by the investigator

Exclusion criteria:

1) Hospitalization for Diabetic Ketoacidosis in the last 6 months will be reviewed
2) Severe hypoglycemia requiring assistance in the last 3 months will be reviewed

Participate

Fill out the following form if you want to participate in this research

Method of contact

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Additional information

Contact information

Michelle Smith, RN, CDE, study nurse

Principal investigator:

Ronald Sigal

Clinical trial:

Yes

REB-ID:

REB25-1093