None listed
Conditions
Brief summary
Phase 1 of the study will obtain safety data for the investigational automated insulin delivery EOPatch pump. We hypothesize that the EOPatch pump is as safe and is as effective at reducing post-prandial blood glucose excursions in persons with Type 1 diabetes who under-bolus mealtime insulin.
Interventions
Phase 1 of the study will be completed before commencing on Phase 2. Participants in Phase 1 of the study will be offered the option of participating in Phase 2 of the study - this will be registered in a separate record. Phase 1: 50% insulin bolus for a carbohydrate load - the EOPatch pump will be used during two in-clinic visits (up to 8 hours each including baseline measurements, EOPatch pump insertion/programming and meal challenge) conducted by a doctor and nurse experienced in managing hypo/hyperglycaemia during daylight hours in a major university hospital with a full resuscitation team available if necessary - the EOPatch pump will be inserted by study staff at the start of the in-clinic visit for the meal challenge and removed at the end of each meal challenge - participants will receive (in randomized order) a full insulin bolus (100%) and an underestimated insulin bolus (50%) during the meal challenge with a carbohydrate load (80g high carbohydrate meal) and have monitoring of glycaemia over 6 hours - the first and second meal challenge will be 5-7 days apart (to avoid weekends so as to allow for access to a full resuscitation team, which will be difficult on weekends) EOPatch pump use will be monitored on a regular basis (during the 30-minutely blood glucose checks) to ensure participants are in Auto mode during the meal challenges in the in-clinic visits and pump analytics can be accessed to verify that. Check-in and discharge times for these in-clinic visit will be documented in the case report forms.
Sponsors
Study design
Eligibility
Inclusion criteria
- Type 1 diabetes, of at least 6 months duration. - Age 21-75 Years - Insulin pump usage at the time of screening and for at least 3 months prior to screening. - HbA1c between 5.8% and 9.0% - Willingness and ability to follow all study procedures and to attend all clinic visits. - Living with a person knowledgeable regarding the management of hypoglycaemia. - No episodes of diabetic ketoacidosis and severe hypoglycaemia within the last 3 months
Exclusion criteria
- Chronic kidney disease as defined by estimated-GFR < 45 ml/min - Inability to read pump or CGM display due to reduced visual acuity - Presence of unstable ischaemic heart disease or myocardial infarction within the last 3 months. - Cognitive limitations precluding the participant’s ability to operate the insulin pump. - Any major active medical condition which in the investigator’s opinion precludes involvement in the study. Known active infection such as HIV or hepatitis - Schizophrenia or other untreated mental illness - Chronic substance abuse - Major surgical procedure within 30 days prior to screening - Bleeding disorder, or treatment with anticoagulants - Allergy to Lispro insulin - Allergy to acrylate-based skin adhesives - Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. - Diabetic ketoacidosis or major hypoglycemia within the last 6 months - Insulin resistance as defined by insulin requirement of more than 200 units per day - Use of glucose-lowering medications other than insulin - Need for uninterrupted treatment with acetaminophen