Type 1 Diabetes MellitusNCT04476472
Omnipod Horizon™ Automated Glucose Control System Preschool Cohort
A study of Type 1 Diabetes Mellitus, run by Insulet Corporation at 10 sites in United States.
Trial summary
Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 94-day (13-week) hybrid closed-loop phase conducted in an outpatient setting, and an optional 12-month extension phase. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 10 sitesUnited States
- Study dates
- 8 Sep 2020to 12 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age at time of consent 2.0-5.9 years
- Living with parent/legal guardian
- Diagnosed with type 1 diabetes. Diagnosis is based on investigator's clinical judgment
- Deemed appropriate for pump therapy per investigator's assessment taking into account previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
- Investigator has confidence that the subject and/or parent/guardian/caregiver can successfully operate all study devices and is capable of adhering to the protocol
- Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog or Apidra during the study
Show all 12Show fewer
- Willing to wear the system continuously throughout the study
- Willing to participate in challenges for 2 consecutive days, consisting of a minimum of 3 hours of activity per day and dietary challenge by reducing the number of carbohydrates entered for a given meal by 50%
- A1C <10% at screening visit
- Subject and/or parent/guardian must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as the sole source of Dexcom data (with the exception of the Dexcom Follow App) during the hybrid closed-loop phase
- Subject and/or parent/guardian is able to read and speak English fluently
- Has a parent/legal guardian willing and able to sign the ICF.
Who cannot join
- A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
- History of severe hypoglycemia in the past 6 months
- History of DKA in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis
- Diagnosed with sickle cell disease
- Diagnosed with hemophilia or any other bleeding disorders
- Plans to receive blood transfusion over the course of the study
Show all 15Show fewer
- Clinical evidence of acute or chronic kidney disease (e.g. estimated GFR < 45) or currently on hemodialysis
- History of adrenal insufficiency
- Has taken oral or injectable steroids within the past 8-weeks or plans to take oral or injectable steroids during the course of the study
- Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
- Plans to use insulin other than U-100 insulin intended for use in the study device during the course of the study
- Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide)
- Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism
- Currently participating or plans to participate in another clinical study using an investigational drug or device other than the Omnipod Horizon™ Automated Glucose Control System during this study period
- Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Atlanta Diabetes
Atlanta, Georgia, 30318
Joslin Diabetes Center
Boston, Massachusetts, 02215
University of Virginia
Charlottesville, Virginia, 22904
University Hospitals Cleveland
Cleveland, Ohio, 44106
University of Colorado Denver
Denver, Colorado, 80045
Baylor College of Medicine
Houston, Texas, 77030
Yale University School of Medicine
New Haven, Connecticut, 06511
Stanford University
Palo Alto, California, 94305
International Diabetes Center
Saint Louis Park, Minnesota, 55416
SUNY Syracuse
Syracuse, New York, 13244
About this study
Official title: Evaluating the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Children With Type 1 Diabetes Aged 2.0-5.9 Years: Preschool Cohort
Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 94-day (13-week) hybrid closed-loop phase conducted in an outpatient setting, and an optional 12-month extension phase.
Read the detailed description
The study schedule will consist of a standard therapy data collection phase followed by a hybrid closed-loop phase.
Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects, or their caregivers, will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system (CGM) and remain on current multiple daily injections (MDI) or pump therapy. This will be followed by a 94-day (13-week) hybrid closed-loop phase, conducted in an outpatient setting where subjects, or their caregivers, will manage their diabetes at home using the Omnipod Horizon™ Automated Glucose Control System. After completing the 94-day hybrid closed-loop phase, subjects will have the option to continue using the system for an additional 12 months.
During the hybrid closed-loop phase, a subset of subjects will participate in 2-days of supervised meal and exercise challenges.
The hybrid closed-loop phase will begin on Study Day 1.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Omnipod Horizon™ Automated Glucose Control System
- Keywords
- T1D, Omnipod
- 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.
Omnipod Horizon™ Automated Glucose Control SystemDevice
The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Receives: Device: Omnipod Horizon™ Automated Glucose Control System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate of Severe Hypoglycemia (Events Per Person Months)
Number of severe hypoglycemia events reported in "events per person months" units.
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)
Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months)
Number of DKA events reported in "events per person months" units.
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)
Glycated Hemoglobin (A1C)
Measures device effectiveness
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (180 days, 270 days, 360 days, and 450 days) compared to baseline
Time in Range 70-180 mg/dL
Measures device effectiveness
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days)
Secondary outcomes (19)
Glycated Hemoglobin (A1C)
Measures device effectiveness
Measured: Hybrid closed-loop (94 days, 180 days, 270 days, and 450 days) compared to baseline
Percent of Time in Range 70-140 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Percent of Time > 180 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Percent of Time ≥ 250 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Percent of Time ≥ 300 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Percent of Time < 70 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Percent of Time < 54 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Mean Glucose
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Standard Deviation
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Coefficient of Variation
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time
Measure of system usage in Automated and Manual modes. Percentage of time in Automated and Manual mode do not add up to 100% due to missing data from participants not using the Omnipod 5 system (e.g., not wearing a Pod).
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 (450 days)
Glucose Management Indicator (GMI)
Glucose Management Indicator (%) approximates the laboratory hemoglobin A1c (%) expected based on average glucose readings from continuous glucose monitors from the last 14 days or more.
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Insulin (TDI) (Units)
Measure of insulin requirements
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Insulin (TDI) (Units/kg)
Measure of insulin requirements
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Basal Insulin (Units)
Measure of insulin requirements
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Basal Insulin (Units/kg)
Measure of insulin requirements
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Bolus Insulin (Units)
Measure of insulin requirements
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Bolus Insulin (Units/kg)
Measure of insulin requirements
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Body Mass Index (BMI) (kg/m^2)
Measure of change in weight
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start8 Sep 2020
- Primary completion17 Jan 2022
- Study completion12 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 Diabetes MellitusStudies 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
- Model description
- single-arm, multi-center, prospective clinical study
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insulet Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Buckingham, MD, Study chair, Stanford School of MedicineSue Brown, MD, Study chair, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476472
- Sponsor's protocol ID
- Horizon™ Preschool Cohort
- Status last verified
- Jan 2024
- First submitted
- 15 Jul 2020
- Last updated
- 14 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
DeSalvo DJ, Bode BW, Forlenza GP, Laffel LM, Buckingham BA, Criego AB, Schoelwer M, MacLeish SA, Sherr JL, Hansen DW, Ly TT. Glycemic Outcomes Persist for up to 2 Years in Very Young Children with the Omnipod(R) 5 Automated Insulin Delivery System. Diabetes Technol Ther. 2024 Jun;26(6):383-393. doi: 10.1089/dia.2023.0506. Epub 2024 Feb 21.
PubMed 38277156Sherr JL, Bode BW, Forlenza GP, Laffel LM, Schoelwer MJ, Buckingham BA, Criego AB, DeSalvo DJ, MacLeish SA, Hansen DW, Ly TT; Omnipod 5 in Preschoolers Study Group:; Sherr JL, Weyman K, Tichy E, VanName M, Brei M, Zgorski M, Steffen A, Carria L, Bode BW, Busby A, Forlenza GP, Wadwa RP, Slover R, Cobry E, Messer L, Laffel LM, Isganaitis E, Ambler-Osborn L, Freiner E, Turcotte C, Volkening L, Schoelwer M, Brown SA, Krauthause K, Emory E, Oliveri M, Buckingham BA, Ekhlaspour L, Kingman R, Criego AB, Schwartz BL, Gandrud LM, Grieme A, Hyatt J, DeSalvo DJ, McKay S, DeLaO K, Villegas C, MacLeish SA, Wood JR, Kaminski BA, Casey T, Campbell W, Behm K, Adams R, Hansen DW, Stone SL, Bzdick S, Bulger J, Agostini L, Doolittle S, Kivilaid K, Kleve K, Ly TT, Dumais B, Vienneau T, Huyett LM, Lee JB, O'Connor J, Benjamin E. Safety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial. Diabetes Care. 2022 Aug 1;45(8):1907-1910. doi: 10.2337/dc21-2359.
PubMed 35678724
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Children With Type 1 Diabetes Aged 2.0-5.9 Years: Preschool Cohort
- ClinicalTrials.gov ID
- NCT04476472
- Acronym / sponsor ID
- Horizon™ Preschool Cohort
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- T1D, Omnipod
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Insulet CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Posted 14 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 94-day (13-week) hybrid closed-loop phase conducted in an outpatient setting, and an optional 12-month extension phase.
Detailed description
The study schedule will consist of a standard therapy data collection phase followed by a hybrid closed-loop phase.
Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects, or their caregivers, will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system (CGM) and remain on current multiple daily injections (MDI) or pump therapy. This will be followed by a 94-day (13-week) hybrid closed-loop phase, conducted in an outpatient setting where subjects, or their caregivers, will manage their diabetes at home using the Omnipod Horizon™ Automated Glucose Control System. After completing the 94-day hybrid closed-loop phase, subjects will have the option to continue using the system for an additional 12 months.
During the hybrid closed-loop phase, a subset of subjects will participate in 2-days of supervised meal and exercise challenges.
The hybrid closed-loop phase will begin on Study Day 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-arm, multi-center, prospective clinical study
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Omnipod Horizon™ Automated Glucose Control SystemAll subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Age at time of consent 2.0-5.9 years
- Living with parent/legal guardian
- Diagnosed with type 1 diabetes. Diagnosis is based on investigator's clinical judgment
- Deemed appropriate for pump therapy per investigator's assessment taking into account previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
- Investigator has confidence that the subject and/or parent/guardian/caregiver can successfully operate all study devices and is capable of adhering to the protocol
Key exclusion criteria (15 listed)
- A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
- History of severe hypoglycemia in the past 6 months
- History of DKA in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis
- Diagnosed with sickle cell disease
- Diagnosed with hemophilia or any other bleeding disorders
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 |
|---|---|---|
| Omnipod Horizon™ Automated Glucose Control SystemThe Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. | Device | Treatment |
Primary outcome
Incidence Rate of Severe Hypoglycemia (Events Per Person Months)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)
Number of severe hypoglycemia events reported in "events per person months" units.
Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)
Number of DKA events reported in "events per person months" units.
Glycated Hemoglobin (A1C)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (180 days, 270 days, 360 days, and 450 days) compared to baseline
Measures device effectiveness
Time in Range 70-180 mg/dL
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days)
Measures device effectiveness
19 secondary outcomes
Glycated Hemoglobin (A1C)
Time frame: Hybrid closed-loop (94 days, 180 days, 270 days, and 450 days) compared to baseline
Percent of Time in Range 70-140 mg/dL
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Percent of Time > 180 mg/dL
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Percent of Time ≥ 250 mg/dL
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Percent of Time ≥ 300 mg/dL
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Percent of Time < 70 mg/dL
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Percent of Time < 54 mg/dL
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Mean Glucose
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Standard Deviation
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Coefficient of Variation
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 (450 days)
Glucose Management Indicator (GMI)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Insulin (TDI) (Units)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Insulin (TDI) (Units/kg)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Basal Insulin (Units)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Basal Insulin (Units/kg)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Bolus Insulin (Units)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Bolus Insulin (Units/kg)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Body Mass Index (BMI) (kg/m^2)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38277156DeSalvo DJ, Bode BW, Forlenza GP, Laffel LM, Buckingham BA, Criego AB, Schoelwer M, MacLeish SA, Sherr JL, Hansen DW, Ly TT. Glycemic Outcomes Persist for up to 2 Years in Very Young Children with the Omnipod(R) 5 Automated Insulin Delivery System. Diabetes Technol Ther. 2024 Jun;26(6):383-393. doi: 10.1089/dia.2023.0506. Epub 2024 Feb 21.
- Derived from this study: PubMed 35678724Sherr JL, Bode BW, Forlenza GP, Laffel LM, Schoelwer MJ, Buckingham BA, Criego AB, DeSalvo DJ, MacLeish SA, Hansen DW, Ly TT; Omnipod 5 in Preschoolers Study Group:; Sherr JL, Weyman K, Tichy E, VanName M, Brei M, Zgorski M, Steffen A, Carria L, Bode BW, Busby A, Forlenza GP, Wadwa RP, Slover R, Cobry E, Messer L, Laffel LM, Isganaitis E, Ambler-Osborn L, Freiner E, Turcotte C, Volkening L, Schoelwer M, Brown SA, Krauthause K, Emory E, Oliveri M, Buckingham BA, Ekhlaspour L, Kingman R, Criego AB, Schwartz BL, Gandrud LM, Grieme A, Hyatt J, DeSalvo DJ, McKay S, DeLaO K, Villegas C, MacLeish SA, Wood JR, Kaminski BA, Casey T, Campbell W, Behm K, Adams R, Hansen DW, Stone SL, Bzdick S, Bulger J, Agostini L, Doolittle S, Kivilaid K, Kleve K, Ly TT, Dumais B, Vienneau T, Huyett LM, Lee JB, O'Connor J, Benjamin E. Safety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial. Diabetes Care. 2022 Aug 1;45(8):1907-1910. doi: 10.2337/dc21-2359.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes Mellitus
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Bruce Buckingham, MD study chair
Stanford School of Medicine
Sue Brown, MD study chair
University of Virginia
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Type 1 Diabetes Mellitus, run by Insulet Corporation at 10 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 15 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 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 14 Feb 2024). 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?
Incidence Rate of Severe Hypoglycemia (Events Per Person Months) (time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)). The study lists 4 primary outcomes in all. 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 NCT04476472, 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 14 Feb 2024.