Diabetes
Conditions
Keywords
diabetes, post prandial glucose level, insulin, pharmacokinetics, pharmacodynamics
Brief summary
The aim of this study is to test the pharmacodynamics of insulin analogs and their dependence on external and physiological alterations. We plan to compare the pharmacodynamics of insulin analog delivery in regular conditions and in the presence of increased perfusion of the delivery site, achieved by way of local warming and movement
Interventions
DEVICEwith heat and massage
For the with intervention group a treatment to the injection site is applied after each insulin bolus injection.
Sponsors
Insuline Medical Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Participant age between 18- 65 years old 2. Type I or Type II diabetes 3. HbA1c 6-12% 4. Does not suffer from sever hypertension, kidney, liver or heart disease 5. Does not suffer from active Ischemic heart disease 6. Is willing to sign the consent form
Exclusion criteria
1. Participants age \< 18 or \> 65 2. Pregnancy 3. Breast feeding women 4. Un-controlled diabetes, HbA1c values \> 12% range 5. Suffers from active Ischemic heart disease 6. Alcohol addiction 7. Is not prepared to signed the informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin blood level with and with out the intervention | at the end of every daily study |
Countries
Israel
Outcome results
None listed