Efficacy and Safety of Android Artificial Pancreas System in Adult Patients With Type 1 Diabetes Mellitus in China
Study Details
Study Description
Brief Summary
This is a 26-week randomized, open-label, two-arm, two-phase, crossover, superiority trial. Participants will receive two interventions at different phases, including Android artificial pancreas system(AndroidAPS-rt-CGM) and sensor augmented 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 blood glucose meters and compatible test strips (Bayer; Bayer Consumer Care; USA).The efficacy outcomes( change in percentage of sensor glucose values below, within, and above target range; mean sensor glucose value,measures of glycemic variability and the change in centralized HbA1c) and safety outcomes(including the frequency of hypoglycemia events, diabetic ketoacidosis, and other serious adverse events) from baseline to the end of each period will be compared between AndroidAPS-rt-CGM and SAP in adult T1DM patients with suboptimal glycemic control.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AndroidAPS-rt-CGM 1) AiDEX G7 continuous glucose monitoring (an rt-CGM);2) Equil® insulin patch pump;3) AndroidAPS algorithm implemented in Android smartphone |
Device: AndroidAPS-rt-CGM;
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.
|
| Active Comparator: sensor augmented pump(SAP) SAP includes only Equil® insulin patch pump and AiDEX G7 continuous glucose monitoring. |
Device: sensor augmented pump(SAP);
Insulin therapy (aspart, lispro or glulisine) with sensor augmented pump(SAP).SAP includes only Equil® insulin patch pump and AiDEX G7 continuous glucose monitoring.
|
Outcome Measures
Primary Outcome Measures
- Time in range(TIR) [during week-2-0,week 10-12,week 12-14,and week 24-26]
The change in TIR(3.9-10.0 mmol/l) as measured by CGM from baseline (week-2 to week 0 in the first phase; week 12 to week 14 in the second phase) to the end of each phase(week 10 to week 12 in the first phase; week 24 to week 26 in the second phase) will be assessed.
Secondary Outcome Measures
- Glycosylated Hemoglobin A1c(HbA1c) [in week 0, week 12, week14 and week26]
The change in centralized HbA1c from baseline (week 0 and week 14) to the end of each phase(week 12 and week 26) will be assessed.
- Time in target range(TIT) [during week-2-0,week 10-12,week 12-14,and week 24-26]
The change in TIT(3.9-7.8 mmol/l) as measured by CGM from baseline (week-2 to week 0; and week 12 to week 14) to the end of each phase(week 10 to week 12; and week 24 to week 26) will be assessed.
- Time above range(TAR) [during week-2-0,week 10-12,week 12-14,and week 24-26]
The change in TAR(> 10.0 mmol/L and > 13.9 mmol/L) as measured by CGM from baseline(week-2 to week 0; and week 12 to week 14) to the end of each phase (week 10 to week 12; and week 24 to week 26) will be assessed.
- Time below range(TBR) [during week-2-0,week 10-12,week 12-14,and week 24-26]
The change in TBR(< 3.9 mmol/L and <3.0 mmol/L) as measured by CGM from baseline(week-2 to week 0; and week 12 to week 14) to the end of each phase (week 10 to week 12; and week 24 to week 26) will be assessed.
- Mean blood glucose value(MBG) [during week-2-0,week 10-12,week 12-14,and week 24-26]
The change in MBG as measured by CGM from baseline(week-2 to week 0; and week 12 to week 14) to the end of each phase (week 10 to week 12; and week 24 to week 26) will be assessed.
- Standard deviation(SD) [during week-2-0,week 10-12,week 12-14,and week 24-26]
The change in SD as measured by CGM from baseline(week-2 to week 0; and week 12 to week 14) to the end of each phase (week 10 to week 12; and week 24 to week 26) will be assessed.
- Coefficient of variation(CV) [during week-2-0,week 10-12,week 12-14,and week 24-26]
The change in CV as measured by CGM from baseline(week-2 to week 0; and week 12 to week 14) to the end of each phase (week 10 to week 12; and week 24 to week 26) will be assessed.
- Mean amplitude of glucose excursions(MAGE) [during week-2-0,week 10-12,week 12-14,and week 24-26]
The change in MAGE as measured by CGM from baseline(week-2 to week 0; or week 12 to week 14) to the end of each phase (week 10 to week 12; or week 24 to week 26) will be assessed.
- the Chinese version of Hypoglycemia Fear Survey II-Worry Scale(HFS-II) [in week 0 ,week 12, week 14, and week 26]
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).
- European quality of life-5 Dimension-5 Level Health Questionnaire(EQ-5D-5L) [in week 0 ,week 12, week 14, and week 26]
The Chinese version of the EQ-5D-5L is widely used to evaluate the quality of life. The EQ-5D-5L is converted to a single summary index by applying a formula that attaches weights to each dimension's levels. The formula is based on evaluating EQ-5D health states from general population samples. It contains the health description system and Visual Analogue Score (VAS). The health description system includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item is rated on five levels from 1(no problems) to 5(severe problems). Moreover, the EQ-VAS is to evaluate the health condition assessed by patients. The top score (100) means the best health state, and the bottom one (0) means the worst. The change in EQ-5D-5Ls will be assessed in week 12 and week 26 adjusted for baseline(weeks 0 and 14).
- Diabetes Distress Scale(DDS) [in week 0 ,week 12, week 14, and week 26]
The Chinese version of the Diabetes Distress Scale is applied to assess diabetes-related emotional distress in Chinese diabetic patients. The scale consists of 17 items and contains four domains: the emotional burden sub-scale, physician-related distress subscale, regimen-related distress subscale, and diabetes-related interpersonal distress. Each item is rated on a 6-point Likert scale from 1(no distress) to 6(greatest distress), and an average score ≥3 as a cut-off point is considered with more than a moderate distress. The change in DDS will be assessed in week 12 and week 26 adjusted for baseline(weeks 0 and 14).
- Frequency of hypoglycemia events [12 weeks for each arm of the crossover]
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) [12 weeks for each arm of the crossover]
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 [12 weeks for each arm of the crossover]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
Prior to this study:
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Type 1 diabetes mellitus(T1DM) was diagnosed by an endocrinologist for at least one year.
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Aged from 18 to 75 years.
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HbA1c was 7.0% ~ 11%.
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on multiple daily injection(MDI) or insulin pump therapy for ≥3 months with less than 20% insulin dose changes.
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The total daily dose(TDD) were≥0.3 u/kg /day, and the basal rate was ≥0.05 u/hour.
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Regular self-monitoring of blood glucose (≥3 times per day) for ≥2 months.
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Lived with an adult willing to care for the subject during the study.
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Women of childbearing age are willing to use appropriate contraceptive measures.
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Willing to follow the research protocol.
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Have daily access to a Wi-Fi network.
Exclusion Criteria:
Prior to this study:
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Severe acute or chronic complications of diabetes mellitus.
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Frequent severe hypoglycemia in the past three months.
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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.
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Abnormal liver function (ALT was 2.5 times higher than the upper limit of normal).
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Moderate to severe renal impairment (eGFR<60ml/min/1.73m2).
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Clinically significant heart disease.
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Pregnant or planning pregnancy.
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Used drugs that can interfere with glucose metabolism (e.g., exogenous glucocorticoids, nonselective beta-blockers, monoamine oxidase inhibitors) in the past eight weeks.
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Frequent acetaminophen, drug abuse, and excessive drinking.
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Known allergy to medical-grade adhesives or CGM and its affiliated components.
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Severe visual or hearing impairment.
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Severe skin disease at the site of sensor implantation.
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Plan to undergo elective surgery requiring general anesthesia during the study.
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Eating disorders such as anorexia or bulimia.
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Other physical or psychological conditions deemed inappropriate for inclusion by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jinhua Yan | Guangzhou | Guangdong | China | 510630 |
Sponsors and Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University
Investigators
- Principal Investigator: Jinhua Yan, phD, Third Affiliated Hospital, Sun Yat-Sen University
- Principal Investigator: Wen Xu, phD,MD, Third Affiliated Hospital, Sun Yat-Sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MLei