None listed
Conditions
Brief summary
Type 1 diabetes is a condition treated with lifelong insulin injections and requires multiple daily injections. These injections are usually well tolerated but cause discomfort in some patients. A new jet injector device for painless injections of insulin without needles has been developed. This has been trialled in subjects without diabetes and shown to be an effective way of delivering insulin. Initial studies also show that the insulin appears to be absorbed more rapidly using this device compared with the usual subcutaneous injections. This is of potential benefit to patients with Type 1 Diabetes who often find that blood glucose levels rise too rapidly after meals using conventional subcutaneous injections of insulin. This study is designed test the safety and efficacy of the InsuJet device in patients with type 1 diabetes, and to measure the rise in blood glucose levels after a meal using Insujet to administer the insulin as compared with standard subcutaneous injections.
Interventions
The device InsuJetTM is intended for the subcutaneous injection of insulin, without the use of needles. The study is designed to compare the effect of immediate pre prandial administration by InsuJet device versus subcutaneous injection on the pharmacokinetics and metabolic effects of rapid-acting human insulin analogue aspart in people with Type 1 Diabetes Mellitus following a liquid meal tolerance test. This trial is a cross over design study involving a screening visit and two site visits. Th
The device InsuJetTM is intended for the subcutaneous injection of insulin, without the use of needles. The study is designed to compare the effect of immediate pre prandial administration by InsuJet device versus subcutaneous injection on the pharmacokinetics and metabolic effects of rapid-acting human insulin analogue aspart in people with Type 1 Diabetes Mellitus following a liquid meal tolerance test. This trial is a cross over design study involving a screening visit and two site visits. The time period between the two site visits is one week. At the site visits the participant blood samples will be taken at t=-10 mins and t=0 mins. Immediately after the t=0 mins blood sample, an injection of Insulin aspart will be administered using the InsuJet device or Insulin pen based on the allocation of treatment by randomisation technique. Patient should have known insulin to carbohydrate ratio for calculating the bolus dose of rapid acting insulin analogue. Then the participant will drink the standardised liquid meal (Each can contains1120kJ, 9.3g protein, 43g carbohydrate and 6.5g fat). Further blood samples will be taken at +15, +30, +45, 60, +90, +120, +150, +180 and +240 mins. Venous samples will be taken for plasma glucose and serum insulin levels. For purposes of safety, capillary blood glucose monitoring by glucometer will be done at +30, +60, +120, +180 and +240 mins. The test will take place in a controlled laboratory environment under the supervision of trained clinical research staff. Processing will be done on site and assays will be assessed at the local laboratory after appropriate storage. The study has two arms. 1. Insulin aspart administered by InsuJet device. 2. Insulin aspart administered by Insulin pen.
Sponsors
Baker IDI Heart and Diabetes Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patient has given informed consent obtained before any trial-related activities. 2. Type 1 diabetes defined as patient on insulin treatment within one year of diagnosis. 3.Insulin treatment: on any insulin regimen for more than one year and on stable insulin basal-bolus regimen (defined as total daily dose of insulin not varying by > 20% from usual total daily dose) for greater than or equal to 3 months at the time of inclusion. Patient should have known insulin to carbohydrate ratio for calculating the bolus dose of rapid acting insulin analogue. 4. HbA1c less than or equal to 10%. 5. Age between 18 and 65 years. 6. BMI between 18 and 40 kg/m2
Exclusion criteria
1. Known or suspected allergy to any of the trial products, including the food product used for the meal tolerance test. 2. History of major hypoglycaemic episodes, defined as hypoglycaemic events requiring external assistance within the last year. 3. Unstable angina, myocardial infarction or heart failure (NYHA class III-IV)less than or equal to 3 months of inclusion. 4. Seated BP more than or equal to 180/100 mmHg. 5. Impaired hepatic function (ALT alanine transaminase > 2.5 x upper reference limit of the local laboratory.) 6. Impaired renal function (eGFR MDRD < 30 ml/min/1.73m2). 7. Pregnancy at time of inclusion. 8. Mental incapacity, unwillingness, language barrier or other factor that in the investigator’s opinion precludes adequate understanding of the trial procedure or cooperation with trial site personnel. 9.Abuse of alcohol or narcotics 10. Known or suspected gastro paresis, or previous gastric surgical procedure that may interfere with gastric emptying (e.g. gastric laparoscopic banding, gastric stapling and partial gastrectomy). 11. Regular use of gastric prokinetic agents or other agents known to affect the motility of the stomach, such as anticholinergic agents (topical eye drops are allowed) or tricyclic antidepressants within 2 days of inclusion. 12. Glucocorticoid use within 7 days of inclusion (excluding inhaled or topical steroid). 13.Receipt of any investigational product within 30 days prior to inclusion in this trial
Outcome results
None listed