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Feasibility study for Development of an All-In-One Combined Insulin Cannula and Glucose Sensor as Part of a Automated Patch-Pump Insulin Delivery System in Adults with Type 1 Diabetes

Feasibility study for Development of an All-In-One Combined Insulin Cannula and Glucose Sensor as Part of a Patch-Pump Closed Loop Insulin Delivery System in Adults with Type 1 Diabetes (Phase 1)

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000912886
Enrollment
3
Registered
2021-07-14
Start date
2021-07-29
Completion date
2021-08-06
Last updated
2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 hy

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

St Vincent's Hospital Melbourne
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
21 Years to 75 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026