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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00050920 | Other Identifier | Research Ethics Board - Advarra |
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| Name | Class |
|---|---|
| Adocia | INDUSTRY |
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This pilot study is a 50-hour randomized, open-label, crossover study in an inpatient setting assessing the safety, pharmacodynamics, pharmacokinetics, and closed-loop efficacy of i) BC LisPram delivery and ii) rapid insulin delivery.
Subjects will be randomized to intervention sequences. The first 6 participants will be randomly allocated to a sequence of three treatments composed of (i) treatment with active comparator insulin lispro, (ii) treatment with BC LisPram, and (iii) treatment with BC LisPram (dual wave bolus). The following 10 participants will be randomly allocated to a sequence of either two or three treatments. Each treatment period will last 50 hours. PK/PD assessment will be performed under an open-loop system and will be followed by a 24 hour of closed-loop assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid Insulin lispro - Conventional bolus | Active Comparator | Participants will use subcutaneously-delivered rapid insulin (lispro) through pump therapy. |
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| BC LisPram - Conventional bolus | Experimental | Participants will use subcutaneously-delivered BC LisPram through pump therapy. |
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| BC LisPram - Dual wave bolus | Experimental | Participants will use subcutaneously-delivered BC LisPram through pump therapy. During dual wave bolusing, 50% of the prandial bolus is delivered immediately, and the other 50% delivered over the next 30 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50-Hour Intervention - Rapid Insulin lispro | Drug | Subcutaneous-delivery of insulin lispro using pump therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of Pramlintide | Area under the pramlintide concentration-time curve | Breakfast, lunch, dinner from 0 to 4 hours |
| Pharmacokinetics of Insulin | Area under the insulin concentration-time curve | Breakfast, lunch, dinner from 0 to 4 hours |
| Pharmacokinetics of Paracetamol | Area under the paracetamol concentration-time curve | Breakfast and dinner from 0 to 4 hours |
| Glucose Pharmacodynamics | Area under the sensor glucose concentration-time curve | Breakfast, lunch and dinner from 0 to 4 hours |
| Glucagon Pharmacodynamics | Area under the plasma glucagon concentration-time curve | Breakfast and dinner from 0 to 4 hours |
| Hypoglycaemic episodes | Number of hypoglycaemic episodes during the 0 to 50 hour period. | 0 to 50 hours |
| Gastrointestinal symptoms | Frequency of gastrointestinal symptoms during the 0 to 50 hour period. | 0 to 50 hours |
| Local tolerability at pump injection site | Local tolerability at pump injection site during the 0 to 50 hour period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexia Macina | Contact | +1 514-623-2520 | alexia.macina@affiliate.mcgill.ca |
| Name | Affiliation | Role |
|---|---|---|
| Michael Tsoukas, MD | Applied Medical Informatics Research Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hygea Medical Clinic | Recruiting | Montreal | Quebec | H4A3T2 | Canada |
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| 50-Hour Intervention - BC LisPram | Drug | Subcutaneous-delivery of BC LisPram using pump therapy. |
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| 0 to 50 hours |
| Incidence of adverse event | Number of adverse events during the 0 to 50 hour period. | 0 to 50 hours |