Type 1 DiabetesNCT04492566
Automated Insulin Delivery in Pregnant Patients With Type 1 Diabetes With Extension Into Outpatient at Home
A study testing Automated Insulin Delivery in people with Type 1 Diabetes and Pregnancy, run by Sansum Diabetes Research Institute at 3 sites in United States.
Trial summary
This clinical trial is a safety and feasibility study to assess the performance of an artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring System (HMS) algorithms embedded into the iAPS platform for pregnant patients with type 1 diabetes (T1D). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Type 1 Diabetes, Pregnancy
- What is being tested?
- Automated Insulin Delivery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Jul 2020to 5 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 18 and ≤ 45 years at the time of screening.
- Clinical diagnosis of type 1 diabetes
- Currently using an insulin pump at the time of screening.
- HbA1c ≤ 9%, as performed by point of care or central laboratory testing.
- Pregnant 14+0/7 to 32+6/7 weeks gestation.
- Singleton pregnancy without any other significant known complications, such as preeclampsia, premature rupture of membranes, 2nd/3rd trimester bleeding, fetal growth or fluid abnormalities.
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- No proven or suspected fetal malformations diagnosed in the current pregnancy.
- Bolus for all meals and snacks that contain ≥ 5 grams of carbohydrate.
- Willing to switch to, or continue Novolog or Humalog for the closed-loop session.
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
- Willing to abide by the study protocol and use study-provided devices.
- Have a care partner with the following responsibilities: knowing subject whereabouts and being promptly available for contact by study staff during the day and night, residing in the same dwelling as subject during the night, being agreeable to all device training during the supervised HCL session and additional training on hyper- and hypoglycemia treatment, and assisting with emergency care if needed, such as transportation to the hospital or emergency department.
Who cannot join
- Known unstable cardiac disease or untreated cardiac disease, as revealed by history or physical examination.
- Concurrent use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
- Hemophilia or any other bleeding disorder
- Prior history of Preterm Premature Rupture of Membranes (PPROM)
- Significant hyperemesis interfering with carbohydrate intake
- Laboratory results:
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- A1C > 9%
- Abnormal liver or renal function (Transaminase >2 times the upper limit of normal, creatinine > 1.5 mg/dL)
- Liver and renal function testing drawn at screening visit or within three months prior to screening (for other purposes) will suffice for enrollment purposes
- Dermatological conditions that would preclude wearing a CGM sensor or infusion site.
- Any condition that could interfere with participating in the trial, based on investigator judgment.
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
- Having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
- History of severe hypoglycemia in the past 6 months
- History of DKA requiring hospitalization in the past 6 months
- Significant chronic kidney disease (eGFR < 60) or hemodialysis
- Significant liver disease
- History of adrenal insufficiency
- History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
- History of high dose steroid use in the past 8 weeks
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Mayo Clinic
Rochester, Minnesota, 55905
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
Official title: Supervised Safety and Feasibility Evaluation of the Zone-MPC Control Algorithm Integrated Into the iAPS in Pregnant Patients With Type 1 Diabetes With Extension Into Outpatient at Home
This clinical trial is a safety and feasibility study to assess the performance of an artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring System (HMS) algorithms embedded into the iAPS platform for pregnant patients with type 1 diabetes (T1D).
Read the detailed description
The system will be evaluated on up to 21 pregnant adult subjects with type 1 diabetes age 18-45 years old at three clinical sites (Sansum Diabetes Research Institute, Mayo Clinic Rochester MN and Mt Sinai Hospital, New York City). Subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. During the session, subjects will bolus for all meals and snacks, and will perform their usual daily activities while being accompanied by study medical staff.
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.
- Conditions
- Type 1 Diabetes, Pregnancy
- Being tested
- Automated Insulin Delivery
- Keywords
- type 1 diabetes, pregnancy, artificial pancreas, automated insulin delivery
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Insulin DeliveryDevice
Also called Interoperable Artificial Pancreas System (iAPS)
Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| AID Evaluation | Experimental | After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present.
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Receives: Device: Automated Insulin Delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Target Glucose Range
Time in target glucose range 63-140 mg/dL measured by CGM to determine safety and efficacy of the integrated system
Measured: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Secondary outcomes (15)
Overnight Time in Target Glucose Range
Sensor glucose time within the target range of 63-140 mg/dl overnight
Measured: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Postprandial Time in Target Glucose Range
Sensor glucose time within the target range of 63-140 mg/dl postprandially within 2 hours following meals and 2 hours following meals
Measured: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Glucose < 63 mg/dL
Percent time CGM glucose < 63 mg/dL
Measured: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Glucose < 54 mg/dL
Percent time CGM glucose < 54 mg/dL
Measured: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Glucose > 140 mg/dL
Percent time GGM glucose > 140 mg/dL
Measured: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Glucose > 180 mg/dL
Percent time GGM glucose > 180 mg/dL
Measured: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Hypoglycemic Events Per Week
Number of hypoglycemic events per week, defined as time <54 mg/dL for 15 consecutive minutes followed by time >70 mg/dL for 15 consecutive minutes.
Measured: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Severe Hypoglycemic Events
Number of hypoglycemic events that events that require active assistance of another individual
Measured: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Hyperglycemic Events
Number of episodes with ketones >1 mmol/L
Measured: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Glucose > 250 mg/dL
Percent time GGM glucose > 250 mg/dL
Measured: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Serious Adverse Events (SAE)
The total number of serious adverse events during the clinical trial
Measured: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Serious Adverse Device Events (SADE)
The total number of serious adverse events related to the study device use during the clinical trial
Measured: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Adverse Device Effects (ADE)
The total number of adverse device effects (ADE) during the clinical trial
Measured: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Unanticipated Adverse Device Effects (UADE)
The total number of unanticipated adverse device effects (UADE) during the clinical trial
Measured: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Mean CGM Glucose Level
Mean CGM glucose level during AID use
Measured: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start27 Jul 2020
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sansum Diabetes Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, Harvard University, Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Eyal Dassau, PhD, Principal investigator, Harvard University John A Paulson School of Engineering and Applied SciencesYogish Kudva, MD, Principal investigator, Mayo ClinicCarol Levy, MD, Principal investigator, Icahn School of Medicine at Mount SinaiBarak Rosenn, MD, Principal investigator, Icahn School of Medicine at Mount SinaiGrenye O'Malley, MD, Principal investigator, Icahn School of Medicine at Mount SinaiKristin Castorino, DO, Principal investigator, Sansum Diabetes Research InstituteJordan Pinsker, MD, Principal investigator, Sansum Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492566
- Sponsor's protocol ID
- G200099/S001
- Status last verified
- Jul 2023
- First submitted
- 27 Jul 2020
- Last updated
- 4 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Levy CJ, Kudva YC, Ozaslan B, Castorino K, O'Malley G, Kaur RJ, Levister CM, Church MM, Desjardins D, McCrady-Spitzer S, Ogyaadu S, Trinidad MC, Reid C, Rizvi S, Deshpande S, Zaniletti I, Kremers WK, Pinsker JE, Doyle FJ, Dassau E; LOIS-P Diabetes and Pregnancy Consortium. At-Home Use of a Pregnancy-Specific Zone-MPC Closed-Loop System for Pregnancies Complicated by Type 1 Diabetes: A Single-Arm, Observational Multicenter Study. Diabetes Care. 2023 Jul 1;46(7):1425-1431. doi: 10.2337/dc23-0173.
PubMed 37196353Ozaslan B, Levy CJ, Kudva YC, Pinsker JE, O'Malley G, Kaur RJ, Castorino K, Levister C, Trinidad MC, Desjardins D, Church MM, Plesser M, McCrady-Spitzer S, Ogyaadu S, Nelson K, Reid C, Deshpande S, Kremers WK, Doyle FJ , III, Rosenn B, Dassau E. Feasibility of Closed-Loop Insulin Delivery with a Pregnancy-Specific Zone Model Predictive Control Algorithm. Diabetes Technol Ther. 2022 Jul;24(7):471-480. doi: 10.1089/dia.2021.0521. Epub 2022 Apr 26.
PubMed 35230138
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Safety and Feasibility Evaluation of the Zone-MPC Control Algorithm Integrated Into the iAPS in Pregnant Patients With Type 1 Diabetes With Extension Into Outpatient at Home
- ClinicalTrials.gov ID
- NCT04492566
- Acronym / sponsor ID
- G200099/S001
- Conditions
- Type 1 Diabetes, Pregnancy
- Keywords
- type 1 diabetes, pregnancy, artificial pancreas, automated insulin delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sansum Diabetes Research InstituteUniversity, hospital or other
- Collaborators
- Mayo Clinic, Harvard University, Icahn School of Medicine at Mount Sinai
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Posted 4 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is a safety and feasibility study to assess the performance of an artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring System (HMS) algorithms embedded into the iAPS platform for pregnant patients with type 1 diabetes (T1D).
Detailed description
The system will be evaluated on up to 21 pregnant adult subjects with type 1 diabetes age 18-45 years old at three clinical sites (Sansum Diabetes Research Institute, Mayo Clinic Rochester MN and Mt Sinai Hospital, New York City). Subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. During the session, subjects will bolus for all meals and snacks, and will perform their usual daily activities while being accompanied by study medical staff.
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AID Evaluation | Experimental | Device: Automated Insulin DeliveryAfter completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Age ≥ 18 and ≤ 45 years at the time of screening.
- Clinical diagnosis of type 1 diabetes
- Currently using an insulin pump at the time of screening.
- HbA1c ≤ 9%, as performed by point of care or central laboratory testing.
- Pregnant 14+0/7 to 32+6/7 weeks gestation.
Key exclusion criteria (20 listed)
- Known unstable cardiac disease or untreated cardiac disease, as revealed by history or physical examination.
- Concurrent use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
- Hemophilia or any other bleeding disorder
- Prior history of Preterm Premature Rupture of Membranes (PPROM)
- Significant hyperemesis interfering with carbohydrate intake
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 |
|---|---|---|
| Automated Insulin DeliveryAlso: Interoperable Artificial Pancreas System (iAPS)Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. | Device | AID Evaluation |
Primary outcome
Time in Target Glucose Range
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Time in target glucose range 63-140 mg/dL measured by CGM to determine safety and efficacy of the integrated system
15 secondary outcomes
Overnight Time in Target Glucose Range
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Postprandial Time in Target Glucose Range
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Glucose < 63 mg/dL
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Glucose < 54 mg/dL
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Glucose > 140 mg/dL
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Glucose > 180 mg/dL
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Hypoglycemic Events Per Week
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Severe Hypoglycemic Events
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Hyperglycemic Events
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Glucose > 250 mg/dL
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Serious Adverse Events (SAE)
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Serious Adverse Device Events (SADE)
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Adverse Device Effects (ADE)
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Unanticipated Adverse Device Effects (UADE)
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Mean CGM Glucose Level
Time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37196353Levy CJ, Kudva YC, Ozaslan B, Castorino K, O'Malley G, Kaur RJ, Levister CM, Church MM, Desjardins D, McCrady-Spitzer S, Ogyaadu S, Trinidad MC, Reid C, Rizvi S, Deshpande S, Zaniletti I, Kremers WK, Pinsker JE, Doyle FJ, Dassau E; LOIS-P Diabetes and Pregnancy Consortium. At-Home Use of a Pregnancy-Specific Zone-MPC Closed-Loop System for Pregnancies Complicated by Type 1 Diabetes: A Single-Arm, Observational Multicenter Study. Diabetes Care. 2023 Jul 1;46(7):1425-1431. doi: 10.2337/dc23-0173.
- Results publication: PubMed 35230138Ozaslan B, Levy CJ, Kudva YC, Pinsker JE, O'Malley G, Kaur RJ, Castorino K, Levister C, Trinidad MC, Desjardins D, Church MM, Plesser M, McCrady-Spitzer S, Ogyaadu S, Nelson K, Reid C, Deshpande S, Kremers WK, Doyle FJ , III, Rosenn B, Dassau E. Feasibility of Closed-Loop Insulin Delivery with a Pregnancy-Specific Zone Model Predictive Control Algorithm. Diabetes Technol Ther. 2022 Jul;24(7):471-480. doi: 10.1089/dia.2021.0521. Epub 2022 Apr 26.
- 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.
Eyal Dassau, PhD principal investigator
Harvard University John A Paulson School of Engineering and Applied Sciences
Yogish Kudva, MD principal investigator
Mayo Clinic
Carol Levy, MD principal investigator
Icahn School of Medicine at Mount Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated Insulin Delivery in people with Type 1 Diabetes and Pregnancy, run by Sansum Diabetes Research Institute at 3 sites in United States.
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 12 inclusion and 20 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 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 4 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time in Target Glucose Range (time frame: Duration of iAPS Use During Pregnancy up to 40 weeks of Use). 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 NCT04492566, which also lists 2 linked publications.
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 4 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.