Efficacy and Safety of Android Artificial Pancreas System in Adult Patients With Type 1 Diabetes Mellitus in China

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

AndroidAPS-rt-CGM;

sensor augmented pump(SAP);

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Type 1 diabetes mellitus;, Artificial pancreas system;, Do-it-yourself artificial pancreas system;, Automated insulin delivery;, Hybrid closed loop;, Adult, AndroidAPS

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Prior to this study: Type 1 diabetes mellitus(T1DM) was diagnosed by an endocrinologist for at least one year. Aged from 18 to 75 years. HbA1c was 7.0% ~ 11%. on multiple daily injection(MDI) or insulin pump therapy for ≥3 months with less than 20% insulin dose changes. The total daily dose(TDD) were≥0.3 u/kg /day, and the basal rate was ≥0.05 u/hour. Regular self-monitoring of blood glucose (≥3 times per day) for ≥2 months. Lived with an adult willing to care for the subject during the study. Women of childbearing age are willing to use appropriate contraceptive measures. Willing to follow the research protocol. Have daily access to a Wi-Fi network. Exclusion Criteria: Prior to this study: Severe acute or chronic complications of diabetes mellitus. Frequent severe hypoglycemia in the past three months. Patients who have used closed-loop therapy in the last two months (excluding those who have recently used CGM) and those participating in other studies. Abnormal liver function (ALT was 2.5 times higher than the upper limit of normal). Moderate to severe renal impairment (eGFR<60ml/min/1.73m2). Clinically significant heart disease. Pregnant or planning pregnancy. Used drugs that can interfere with glucose metabolism (e.g., exogenous glucocorticoids, nonselective beta-blockers, monoamine oxidase inhibitors) in the past eight weeks. Frequent acetaminophen, drug abuse, and excessive drinking. Known allergy to medical-grade adhesives or CGM and its affiliated components. Severe visual or hearing impairment. Severe skin disease at the site of sensor implantation. Plan to undergo elective surgery requiring general anesthesia during the study. Eating disorders such as anorexia or bulimia. Other physical or psychological conditions deemed inappropriate for inclusion by the investigator.

Sites / Locations

Jinhua YanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AndroidAPS-rt-CGM

sensor augmented pump(SAP)

Arm Description

1) AiDEX G7 continuous glucose monitoring (an rt-CGM);2) Equil® insulin patch pump;3) AndroidAPS algorithm implemented in Android smartphone

SAP includes only Equil® insulin patch pump and AiDEX G7 continuous glucose monitoring.

Outcomes

Primary Outcome Measures

Time in range(TIR)

TIR(3.9-10.0 mmol/l) derived from CGM will be collected during the last 2 weeks of each phase.

Secondary Outcome Measures

Glycosylated Hemoglobin A1c(HbA1c)

centralized HbA1c will be measured on the last day of each phase

Time in target range(TIT)

TIT(3.9-7.8 mmol/l) derived from CGM will be collected during the last 2 weeks of each phase.

Time above range(TAR)

TAR(> 10.0 mmol/L and > 13.9 mmol/L) derived from CGM will be collected during the last 2 weeks of each phase.

Time below range(TBR)

TBR(< 3.9 mmol/L and <3.0 mmol/L) derived from CGM will be collected during the last 2 weeks of each phase.

Mean blood glucose value(MBG)

MBG derived from CGM will be collected during the last 2 weeks of each phase.

Standard deviation(SD)

SD derived from CGM will be collected during the last 2 weeks of each phase.

Coefficient of variation(CV)

CV derived from CGM will be collected during the last 2 weeks of each phase.

Mean amplitude of glucose excursions(MAGE)

MAGE derived from CGM will be collected during the last 2 weeks of each phase.

the Chinese version of Hypoglycemia Fear Survey II-Worry Scale(HFS-II)

The Chinese version of Hypoglycemia Fear Survey II- Worry Scale is used to evaluate the psychological status of diabetic patients. Change in Hypoglycemia Fear Scale (HFS) score will be assessed in week 12 and week 26 adjusted for baseline(week 0 and week 14). These validated surveys include 18 questions to measure hypoglycemia-related anxiety and fear. Each item is rated on a 5-point Likert scale from 0(never related) to 4(very related). "Never relative" scores 1, " and "very related" scores 4. Patients with higher scores are considered with more anxiety and fear of hypoglycemia. The change in HFS-II will be assessed in week 12 and week 26 adjusted for baseline(weeks 0 and 14).

Frequency of hypoglycemia events

Level 1 is defined as sensor glucose ≤3.9mmol/L;level 2 is defined as sensor glucose ≤3.0mmol/L; level 3 is defined as hypoglycemia accompanied by severe cognitive impairment requiring the assistance of another individual to administer rescue therapy.

Frequency of diabetic ketoacidosis (DKA)

DKA can be diagnosed when the following three points are met: 1)plasma glucose level ≥13.9mmol/L;2)pH<7.3 or bicarbonate <18 mmol/L;3)serum ketone ≥3mmol/L or urine ketone≥2+.

Frequency of serious adverse events about device

Serious adverse device effect(ADE) is defined as an event related to the use of the study device which is fatal or life-threatening, resulting in persistent or substantial disability, or requires (or prolonged) hospitalization.

Full Information

NCT ID

NCT05726461

First Posted

January 18, 2023

Last Updated

July 25, 2023

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

1. Study Identification

Unique Protocol Identification Number

NCT05726461

Brief Title

Efficacy and Safety of Android Artificial Pancreas System in Adult Patients With Type 1 Diabetes Mellitus in China

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 11, 2023 (Actual)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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 system(AndroidAPS-rt-CGM) and sensor-augment pump(SAP), 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 1:1 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 delivery(AID) mode on the first day of phase 1 and phase 2, respectively. AndroidAPS-rt-CGM consists of three components:1) AiDEX G7 continuous glucose monitoring (an rt-CGM);2) Equil® insulin patch pump;3) 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 (3.9-10.0 mmol/L) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases

Keywords

Type 1 diabetes mellitus;, Artificial pancreas system;, Do-it-yourself artificial pancreas system;, Automated insulin delivery;, Hybrid closed loop;, Adult, AndroidAPS

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AndroidAPS-rt-CGM

Arm Type

Experimental

Arm Description

1) AiDEX G7 continuous glucose monitoring (an rt-CGM);2) Equil® insulin patch pump;3) AndroidAPS algorithm implemented in Android smartphone

Arm Title

sensor augmented pump(SAP)

Arm Type

Active Comparator

Arm Description

SAP includes only Equil® insulin patch pump and AiDEX G7 continuous glucose monitoring.

Intervention Type

Device

Intervention Name(s)

AndroidAPS-rt-CGM;

Intervention Description

Insulin therapy (aspart, lispro or glulisine) with AndroidAPS-rt-CGM.AndroidAPS-rt-CGM consists of three components:1) AiDEX G7 continuous glucose monitoring (an rt-CGM);2) Equil® insulin patch pump;3) AndroidAPS algorithm implemented in Android smartphone.

Intervention Type

Device

Intervention Name(s)

sensor augmented pump(SAP);

Intervention Description

Insulin therapy (aspart, lispro or glulisine) with sensor augmented pump(SAP).SAP includes only Equil® insulin patch pump and AiDEX G7 continuous glucose monitoring.

Primary Outcome Measure Information:

Title

Time in range(TIR)

Description

TIR(3.9-10.0 mmol/l) derived from CGM will be collected during the last 2 weeks of each phase.

Time Frame

during the last 2 weeks of each phase

Secondary Outcome Measure Information:

Title

Glycosylated Hemoglobin A1c(HbA1c)

Description

centralized HbA1c will be measured on the last day of each phase

Time Frame

on the last day of each phase

Title

Time in target range(TIT)

Description

TIT(3.9-7.8 mmol/l) derived from CGM will be collected during the last 2 weeks of each phase.

Time Frame