Mini-Dose Glucagon to Treat Non-Severe Hypoglycemia

Inclusion Criteria:

1. Clinical diagnosis of presumed autoimmune T1D and receiving daily insulin

2. Age: 18.0 to < 65.0 years

3. Duration of T1D: ≥2.0 years

4. Body mass index 20.0 to <35.0 kg/m2 and weight 110 to <250 lbs

5. HbA1c <8.5% (point of care or local lab, within past month)

6. Using continuous subcutaneous insulin infusion (CSII) therapy (i.e., insulin pump) forat least 3 months, with no plans to discontinue use during the study (and no use ofactive low glucose suspend feature within the last 4 weeks)

7. Using continuous glucose monitor ≥6 days/week in the last 4 weeks, with no plans todiscontinue continuous glucose monitor use during the study

8. Continuous glucose monitor glucose level <70 mg/dl during daytime hours (e.g., 8am - 10pm) on at least 7 of the past 28 days (a modification can be made for participantswith non-traditional waking hours) evaluated from downloaded CGM data

9. Females must meet one of the following criteria:

• Of childbearing potential and not currently pregnant (negative pregnancy test) orlactating, and agrees to use an accepted contraceptive regimen as described inthe study procedure manual throughout the entire duration of the study (fromscreening visit until study completion); or

• Of non-childbearing potential, defined as a female who has had a hysterectomy ortubal ligation, is clinically considered infertile or is in a menopausal state (at least 1 year without menses)

10. In good general health with no conditions that could influence the outcome of thetrial, and in the judgment of the investigator is a good candidate for the study basedon review of available medical history, physical examination and clinical laboratoryevaluations

11. Willing to adhere to the protocol requirements for the duration of the study

12. Participant has a smart phone available and is able to use it daily

13. Must be enrolled in the T1D Exchange clinic registry or willing to join the clinicregistry

Exclusion Criteria:

1. More than 1 severe hypoglycemic episode in the past 12 months (as defined by anepisode that required third party assistance for treatment)

2. More than 1 episode of diabetic ketoacidosis in the past 12 months (as defined by anepisode diagnosed as diabetic ketoacidosis that required treatment in an emergencydepartment or hospitalization)

3. Presence of cardiovascular, gastrointestinal, liver or kidney disease, or any medicalcondition which, in the judgment of the investigator, could potentiate or predisposeto undesired effects or could interfere with the absorption, distribution, metabolism,or excretion of glucagon or ability to respond appropriately to mild to moderatehypoglycemia.

4. Known presence of hereditary problems of glycogen storage disease, galactose and/orlactose intolerance

5. Males with alcohol use in excess of 3 or more drinks per day, on average and femaleswith alcohol use in excess of 2 or more drinks per day, on average

6. Use of non-insulin anti-diabetic medications

7. Use of daily systemic beta-blocker

8. Use of beta-adrenergic agonists, theophylline (or other methylxanthines)

9. Use of 1st generation anticholinergic drugs (such as Brompheniramine,Chlorpheniramine, Dimenhydrinate, Diphenhydramine, and Doxylamine)

10. Use of systemic corticosteroids

11. History of hypersensitivity to glucagon or any related product or excipient or severehypersensitivity reactions (such as angioedema) to any drugs

12. History of epilepsy or seizure disorder

13. Uncontrolled hypertension, >160 mmHg systolic or >100 mmHg diastolic

14. Currently a high endurance exerciser or plans to perform high endurance exerciseduring study (from screening visit until study completion)

• High endurance exerciser defined as a person who regularly competes in running,cycling, rowing, swimming or any other endurance-based activity for the purposeof competition (>2100 metabolic equivalent of task (MET) minutes per week [i.e. 7METs x 60 minutes x 5 days a week, where 7 METs is equivalent to jogging])

15. Currently following a very low calorie or other weight-loss diet

16. Participation in other studies involving administration of an investigational drug ordevice within 30 days or 5 half-lives, whichever is longer, before screening for thecurrent study or planning to participate in another such study during participation inthe current study