Diabetes Mellitus Type 2 - Insulin-TreatedNCT05409391
Insulin Titration System Based on Deep Learning
A study testing Insulin Titration System in people with Diabetes Mellitus Type 2 - Insulin-Treated, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This is an open-labeled, one-arm intervention trial to access the effect and safety of the Insulin Titration System Based on Deep Learning in patients with Type 2 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus Type 2 - Insulin-Treated
- What is being tested?
- Insulin Titration System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2022to 6 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- age of 18-75 years
- HbA1c between 7.0% and 11.0%.
Who cannot join
- subjects with acute complications of diabetes, such as ketoacidosis or hyperglycemic hyperosmolar state;
- BMI ≥ 45kg/m2;
- women who are pregnant or breast-feeding;
- subjects with severe cardiac, hepatic, renal diseases; subjects with any psychiatric or psychological diseases;
- subjects with severe edema, infections or peripheral circulation disorders, receiving surgery during hospitalization;
- subjects who could not comply with the protocol
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Endocrinology, Zhongshan Hospital Fudan University
Shanghai
About this study
Official title: Study to Assess the Efficacy and Safety of Insulin Titration System Based on Deep Learning on Glucose Control in Type 2 Diabetes Mellitus Patients
This is an open-labeled, one-arm intervention trial to access the effect and safety of the Insulin Titration System Based on Deep Learning in patients with Type 2 Diabetes Mellitus.
Read the detailed description
The study enrolls 13 patients with Type 2 Diabetes in Zhongshan Hospital who are on treatment with insulin. After screening for the inclusion and exclusion criteria, eligible patients will receive insulin dosage titration set by the Insulin Titration System Based on Deep Learning in the intervention trial. The goal of insulin therapy was to achieve preprandial capillary blood glucose between 5.6-7.8 mmol/L and postprandial capillary glucose less than 10.0mmol/L. All patients are studied for 5 consecutive days or untill hospital discharge. For each patient, capillary glucose concentration was measured at 7 time points of fasting, after breakfast, before and after lunch, before and after dinner, and before bedtime a day using Glucometer (Glupad, Sinomedisite, China). Capillary glucose measurements were performed by the nurse staff according to standard procedures with a point-of-care testing device, which is integrated into the HIS system. And continuous glucose monitoring (CGM) was performed using flash glucose monitoring (Abbott Freestyle Libre, USA) placed on the upper left arm. This study will be conducted in the Department of Endocrinology, Zhongshan Hospital,Fudan University.
- Being tested
- Insulin Titration System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Titration SystemDevice
A noval insulin titration system, which is based on deep learning
| Study group | Role | What they receive |
|---|---|---|
| AI | Experimental | Insulin Titration System Based on Deep Learning Receives: Device: Insulin Titration System |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean daily blood glucose concentration
For each patient, capillary glucose concentration was measured at 7 time points of fasting, after breakfast, before and after lunch, before and after dinner, and before bedtime a day using Glucometer (Glupad, Sinomedisite, China). Capillary glucose measurements were performed by the nurse staff according to standard procedures with a point-of-care testing device, which is integrated into the HIS system. The primary outcome is the difference in glycemia control as measured by mean daily blood glucose concentration during the intervention period.
Measured: 5 days
Secondary outcomes (4)
glucose concentration in target range (TIR) of 3.9-10.0 mmol/L
TIR measured by CGM and Capillary glucose measurements, respectively
Measured: 5 days
glucose concentration above range (10.1-13.9 mmol/L or >13.9 mmol/L)
TAR measured by CGM and Capillary glucose measurements, respectively
Measured: 5 days
glucose concentration below range (3.0-3.8 mmol/L or <3.0 mmol/L)
TBR measured by CGM and Capillary glucose measurements, respectively
Measured: 5 days
glycemic variability
glycemic variability measured by CGM and Capillary glucose measurements, respectively
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start15 Jun 2022
- Primary completion6 Oct 2022
- Study completion6 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2 - Insulin-TreatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoying Li, Shanghai Zhongshan Hospital
- Investigators
- Xiaoying Li, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409391
- Sponsor's protocol ID
- ZSE-202205
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2022
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang G, Liu X, Ying Z, Yang G, Chen Z, Liu Z, Zhang M, Yan H, Lu Y, Gao Y, Xue K, Li X, Chen Y. Optimized glycemic control of type 2 diabetes with reinforcement learning: a proof-of-concept trial. Nat Med. 2023 Oct;29(10):2633-2642. doi: 10.1038/s41591-023-02552-9. Epub 2023 Sep 14.
PubMed 37710000
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess the Efficacy and Safety of Insulin Titration System Based on Deep Learning on Glucose Control in Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT05409391
- Acronym / sponsor ID
- ZSE-202205
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-labeled, one-arm intervention trial to access the effect and safety of the Insulin Titration System Based on Deep Learning in patients with Type 2 Diabetes Mellitus.
Detailed description
The study enrolls 13 patients with Type 2 Diabetes in Zhongshan Hospital who are on treatment with insulin. After screening for the inclusion and exclusion criteria, eligible patients will receive insulin dosage titration set by the Insulin Titration System Based on Deep Learning in the intervention trial. The goal of insulin therapy was to achieve preprandial capillary blood glucose between 5.6-7.8 mmol/L and postprandial capillary glucose less than 10.0mmol/L. All patients are studied for 5 consecutive days or untill hospital discharge. For each patient, capillary glucose concentration was measured at 7 time points of fasting, after breakfast, before and after lunch, before and after dinner, and before bedtime a day using Glucometer (Glupad, Sinomedisite, China). Capillary glucose measurements were performed by the nurse staff according to standard procedures with a point-of-care testing device, which is integrated into the HIS system. And continuous glucose monitoring (CGM) was performed using flash glucose monitoring (Abbott Freestyle Libre, USA) placed on the upper left arm. This study will be conducted in the Department of Endocrinology, Zhongshan Hospital,Fudan University.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AI | Experimental | Device: Insulin Titration SystemInsulin Titration System Based on Deep Learning |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- type 2 diabetes
- age of 18-75 years
- HbA1c between 7.0% and 11.0%.
Key exclusion criteria (6 listed)
- subjects with acute complications of diabetes, such as ketoacidosis or hyperglycemic hyperosmolar state;
- BMI ≥ 45kg/m2;
- women who are pregnant or breast-feeding;
- subjects with severe cardiac, hepatic, renal diseases; subjects with any psychiatric or psychological diseases;
- subjects with severe edema, infections or peripheral circulation disorders, receiving surgery during hospitalization;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin Titration SystemA noval insulin titration system, which is based on deep learning | Device | AI |
Primary outcome
mean daily blood glucose concentration
Time frame: 5 days
For each patient, capillary glucose concentration was measured at 7 time points of fasting, after breakfast, before and after lunch, before and after dinner, and before bedtime a day using Glucometer (Glupad, Sinomedisite, China). Capillary glucose measurements were performed by the nurse staff according to standard procedures with a point-of-care testing device, which is integrated into the HIS system. The primary outcome is the difference in glycemia control as measured by mean daily blood glucose concentration during the intervention period.
4 secondary outcomes
glucose concentration in target range (TIR) of 3.9-10.0 mmol/L
Time frame: 5 days
glucose concentration above range (10.1-13.9 mmol/L or >13.9 mmol/L)
Time frame: 5 days
glucose concentration below range (3.0-3.8 mmol/L or <3.0 mmol/L)
Time frame: 5 days
glycemic variability
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Derived from this study: PubMed 37710000Wang G, Liu X, Ying Z, Yang G, Chen Z, Liu Z, Zhang M, Yan H, Lu Y, Gao Y, Xue K, Li X, Chen Y. Optimized glycemic control of type 2 diabetes with reinforcement learning: a proof-of-concept trial. Nat Med. 2023 Oct;29(10):2633-2642. doi: 10.1038/s41591-023-02552-9. Epub 2023 Sep 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoying Li principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin Titration System in people with Diabetes Mellitus Type 2 - Insulin-Treated, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean daily blood glucose concentration (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05409391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.