Clinical trial NCT05726461: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

Prior to this study:

1. Type 1 diabetes mellitus(T1DM) was diagnosed by an endocrinologist for at least one year.
2. Aged from 18 to 75 years.
3. HbA1c was 7.0% \~ 11%.
4. on multiple daily injection(MDI) or insulin pump therapy for ≥3 months with less than 20% insulin dose changes.
5. The total daily dose(TDD) were≥0.3 u/kg /day, and the basal rate was ≥0.05 u/hour.
6. Regular self-monitoring of blood glucose (≥3 times per day) for ≥2 months.
7. Lived with an adult willing to care for the subject during the study.
8. Women of childbearing age are willing to use appropriate contraceptive measures.
9. Willing to follow the research protocol.
10. Have daily access to a Wi-Fi network.

Exclusion Criteria:

Prior to this study:

1. Severe acute or chronic complications of diabetes mellitus.
2. Frequent severe hypoglycemia in the past three months.
3. 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.
4. Abnormal liver function (ALT was 2.5 times higher than the upper limit of normal).
5. Moderate to severe renal impairment (eGFR\<60ml/min/1.73m2).
6. Clinically significant heart disease.
7. Pregnant or planning pregnancy.
8. Used drugs that can interfere with glucose metabolism (e.g., exogenous glucocorticoids, nonselective beta-blockers, monoamine oxidase inhibitors) in the past eight weeks.
9. Frequent acetaminophen, drug abuse, and excessive drinking.
10. Known allergy to medical-grade adhesives or CGM and its affiliated components.
11. Severe visual or hearing impairment.
12. Severe skin disease at the site of sensor implantation.
13. Plan to undergo elective surgery requiring general anesthesia during the study.
14. Eating disorders such as anorexia or bulimia.
15. Other physical or psychological conditions deemed inappropriate for inclusion by the investigator.

Primary outcomes:
measure: Time in range(TIR)
timeFrame: during the last 2 weeks of each phase
Secondary outcomes:
measure: Glycosylated Hemoglobin A1c(HbA1c)
timeFrame: on the last day of each phase
measure: Time in target range(TIT)
timeFrame: during the last 2 weeks of each phase.
measure: Time above range(TAR)
timeFrame: during the last 2 weeks of each phase.
measure: Time below range(TBR)
timeFrame: during the last 2 weeks of each phase.
measure: Mean blood glucose value(MBG)
timeFrame: during the last 2 weeks of each phase.
measure: Standard deviation(SD)
timeFrame: during the last 2 weeks of each phase.
measure: Coefficient of variation(CV)
timeFrame: during the last 2 weeks of each phase.
measure: Mean amplitude of glucose excursions(MAGE)
timeFrame: during the last 2 weeks of each phase.
measure: the Chinese version of Hypoglycemia Fear Survey II-Worry Scale(HFS-II)
timeFrame: in week 0 ,week 12, week 14, and week 26
measure: Frequency of hypoglycemia events
timeFrame: 12 weeks for each arm of the crossover
measure: Frequency of diabetic ketoacidosis (DKA)
timeFrame: 12 weeks for each arm of the crossover
measure: Frequency of serious adverse events about device
timeFrame: 12 weeks for each arm of the crossover
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Jinhua Yan
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Jinhua Yan, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Wen Xu, phD,MD
role: PRINCIPAL_INVESTIGATOR
References: