Type 1 Diabetes
Conditions
Brief summary
The investigators will study the effect of microdoses of glucagon at the site of subcutaneous insulin injection. The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.
Detailed description
People with type 1 diabetes will come fasting in the morning to the research facility on two separate days. Both days participants will have a breakfast of their own choice and their regular dose of meal insulin injected. Lyumjev will be used. Frequently collected blood sampled will be analysed for glucose, insulin and glucagon for 3.5 hours. The procedures will be exactly the same both days except that on one of the days they will be randomised to a small dose of glucagon that will be injected at exactly the same site as Lyumjev insulin is injected.
Interventions
DRUGGlucagon
A micro-dose of glucagon is added exactly at the same site as insulin is injected.
Sponsors
St. Olavs Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One day with glucagon and one day without glucagon
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1: Type 1 diabetes for at least 1 year. 2. Age 18 - 70 years. 3. Last known HbA1c \<86 mmol/mol. 4. Treated with continuous subcutaneous insulin infusion (CSII) by an insulin pump or multiple daily insulin injections (MDII).
Exclusion criteria
1. Pregnant women or women trying to conceive. 2. Any chronic disease, including psychiatric illness, judged incompatible with participation in the study. 3. Unfit for participation for any reason judged by the investigators. 4. Known hypersensitivity to glucagon or any of the excipients of the drug formulation. 5. Known phaeochromocytoma. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the glucose curve | From time 0 minutes to time 60 minutes | The area under the glucose curve (change from baseline glucose level) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under glucose curve | Any other time span from time 0 minutes to time 180 minutes | The area under the glucose curve (change from baseline glucose level) |
| Area under insulin curve | Any time frame from time 0 minutes to time 180 minutes | The area under the insulin curve |
| Area under glucagon curve | Any time frame from time 0 minutes to time 180 minutes | The area under the glucagon curve |
| Pharmacokinetics of insulin | Start from time 0 | Time to Cmax. |
| Pharmacokinetics of glucagon | Start from time 0 | Time to Cmax |
Countries
Norway
Outcome results
None listed