Glucagon Counterregulation in Type 1 Diabetes

Summary

The purpose of this study is to find out whether the combination of insulin and pramlintide is better than insulin alone at helping the pancreas release glucagon in response to a low blood sugar episode.

A secondary goal is to assess whether basal pramlintide will delay gastric emptying.

Conditions

• Type 1 Diabetes Mellitus

Interventions

OTHER

Basal insulin alone

A study insulin pump containing lispro insulin will be programmed to deliver basal lispro insulin at according to the subject's normal basal profile. The carbohydrate ratio(s) and insulin sensitivity factor(s) will be programmed per the subject's usual home parameters.

OTHER

Basal pramlintide and reduced basal insulin

A study insulin pump containing pramlintide will be programmed to deliver pramlintide at 6:1 pramlintide:insulin ratio. Simultaneously, a study insulin pump containing lispro insulin will be programmed to deliver basal lispro insulin at \~25% reduced rate from the subject's normal basal profile. The carbohydrate ratio(s) and insulin sensitivity factor(s) will be programmed per the subject's usual home parameters.

OTHER

CGM

Subjects will be instructed to initiate a Continuous Glucose Monitor (CGM) session 2-3 days prior to both the experimental and control CRU admissions.

OTHER

Acetaminophen test

Consumption of a standardized meal mixed with added 1.5 g liquid acetaminophen

OTHER

Insulin-induced hypoglycemia

During insulin-induced hypoglycemia admission, subjects will receive an insulin bolus(s) dosed to reach blood sugar of less than 55 mg/dL.

OTHER

Exercise-induced hypoglycemia

During exercise-induced hypoglycemia admission, subjects participate in three 15 minute exercise bouts (45 minutes total) to lower blood sugar to less than 55 mg/dL.

Sponsors & Collaborators

• University of Virginia

  lead OTHER

Principal Investigators

• Leon S. Farhy, PhD · University of Virginia

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-20

Primary Completion

2019-03-11

Completion

2019-03-11

Countries

• United States

Study Locations