An interventional study of AndroidAPS-rt-CGM; and sensor augmented pump(SAP); in Diabetes Mellitus, Diabetes Mellitus, Type 1 and Glucose Metabolism Disorders, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 25 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 130 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Prior to this study:
Exclusion Criteria:
Prior to this study:
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;
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 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.
Insulin therapy (aspart, lispro or glulisine) with sensor augmented pump(SAP).SAP includes only Equil® insulin patch pump and AiDEX G7 continuous glucose monitoring.
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.
Time frame: during the last 2 weeks of each phase
Glycosylated Hemoglobin A1c(HbA1c)
centralized HbA1c will be measured on the last day of each phase
Time frame: 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 frame: 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 frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: in week 0 ,week 12, week 14, and week 26
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.
Time frame: 12 weeks for each arm of the crossover
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+.
Time frame: 12 weeks for each arm of the crossover
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.
Time frame: 12 weeks for each arm of the crossover
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Third Affiliated Hospital, Sun Yat-Sen University