Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05726461
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-01-18
Brief Title:
Efficacy and Safety of Android Artificial Pancreas System in Adult Patients With Type 1 Diabetes Mellitus in China
Sponsor:
Third Affiliated Hospital Sun Yat-Sen University
Organization:
Third Affiliated Hospital Sun Yat-Sen University
Study Overview
Official Title:
Efficacy and Safety of Android Artificial Pancreas System Use at Home Among Type 1 Diabetes Mellitus Adults in China Protocol of a 26-Week Free-Living Randomized Open-Label Two-Arm Two-Phase Crossover Trial
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a 26-week randomized free-living open-label two-arm two-phase crossover trial Participants will receive two interventions at different phases including the Android artificial pancreas systemAndroidAPS-rt-CGM and sensor-augment pumpSAP and use marketed rapid-acting insulin analogs insulin Aspart insulin Lispro or insulin Glulisine normally used in their usual clinical care The safety and efficacy of AndroidAPS-rt-CGM and SAP in adult T1DM with suboptimal glycemic control will be compared to explore whether the use of AndroidAPS-rt-CGM in adult T1DM with suboptimal glycemic control will be associated with better glycemic control with no increased hypoglycemia
Detailed Description:
All participants will be free to live during the study Each intervention phase is 12 weeks preceded by a 2-week training period and separated by a 2-week washout period During the training period eligible participants will be trained to use the study rt-CGM and insulin pump and randomly assigned 11 to two treatment sequences after the training period In Sequence A patients use AndroidAPS-rt-CGM for the first intervention period phase 1 and SAP for the second intervention period phase 2 in Sequence B patients use SAP for Phase 1 and AndroidAPS-rt-CGM for Phase 2 Participants who enter sequences A and B will be trained to use the study devices running in automated insulin deliveryAID mode on the first day of phase 1 and phase 2 respectively AndroidAPS-rt-CGM consists of three components1 AiDEX G7 continuous glucose monitoring an rt-CGM2 Equil insulin patch pump3 AndroidAPS algorithm implemented in Android smartphone The participants will use the study patch pump and rt-CGM but the AndroidAPS algorithm and advanced features will not be allowed during the SAP intervention period During the washout period participants will continue using the study insulin pump with their standard settings but the study rt-CGM will be replaced by daily self-monitoring of fingerstick glucose The primary endpoint is time in range 39-100 mmolL derived from CGM The main secondary endpoints include the percentage of sensor glucose values below within and above the target range mean sensor glucose value measures of glycemic variability and centralized HbA1c Safety endpoints mainly include the frequency of hypoglycemia events diabetic ketoacidosis and other serious adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None