Type 1 DiabetesInsuLearn-SMANCT07212179
Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 Diabetes Using Automated Insulin Delivery
A study testing AID + InsuLearn-SMA and AID + CC in people with Type 1 Diabetes, run by Melissa J. Schoelwer at 1 site in United States.
Trial summary
To evaluate the safety and feasibility of a novel self-learning bolus calculator along with simplified meal announcement (AID+InsuLearn-SMA) in adolescents and young adults with T1D using Automated Insulin Delivery. Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- AID + InsuLearn-SMA and AID + CC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2026to 15 Apr 2026
- 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 14 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≥14.0 and ≤21 years old at time of consent
- HbA1c ≤ 10%.
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
- Having used an insulin pump within the last three months.
- Currently using insulin for at least six months
- Willingness to use insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
Show all 15Show fewer
- Willingness to switch to a commercially approved insulin (e.g. lispro or aspart or biosimilar approved products) within the study pump as directed by the study team.
- Has one or more supportive caregivers or companions living with the participant who are knowledgeable about emergency procedures for treatment of severe hypoglycemia and able to contact emergency services and study staff.
- Acceptable forms of contraception for participants of child-bearing potential include hormonal treatments including IUD, abstinence from heterosexual intercourse, vasectomy in partner, barrier methods (e.g. condom or diaphragm).
- For females, not currently known to be pregnant or breastfeeding. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- Willingness to use the study InsuLearn system (CGM, pump, and phone) during the study period.
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
- Access to internet at home and ability to upload data during the study as needed.
- Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol.
- Participant is proficient in reading and writing English.
Who cannot join
- History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- Pregnancy or intent to become pregnant during the trial
- Currently breastfeeding or planning to breastfeed
- Currently being treated for a seizure disorder
- Planned surgery during study duration
Show all 13Show fewer
- History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
- Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals)
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
- Participation in another interventional trial at the time of enrollment.
- Visual impairment/blindness that prevents proper interaction with study equipment
- Participant who may have a falsely eligible HbA1c due to medical conditions or blood donations.
- Participants in whom the G6 CGM may be inaccurate due to interference.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903-2981
About this study
To evaluate the safety and feasibility of a novel self-learning bolus calculator along with simplified meal announcement (AID+InsuLearn-SMA) in adolescents and young adults with T1D using Automated Insulin Delivery.
Read the detailed description
Following recruitment and screening, participants will be randomized to one of two sequences during the Hotel Admission: AID+InsuLearn-SMA→AID+CC or AID+CC→AID+InsuLearn-SMA. All participants will be trained on the study equipment, which includes (i) the DiAs smartphone running the Control-IQ algorithm with either the InsuLearn-SMA bolus calculator or the standard carbohydrate counting bolus calculator, and (ii) the Dexcom CGM. All participants will complete 7 days/6 nights run-in At-Home Period using the AID+CC system (Control-IQ with the standard carbohydrate counting bolus calculator). Participants will then undergo a 2-night supervised hotel admission (approximately 48 hours). During this admission, each participant will consume two standardized meals (dinner and breakfast), during which either the InsuLearn-SMA bolus calculator or the standard CC bolus calculator will be used in a randomized order. Two lunches will be offered during the Hotel Admission but not included in the analysis. Following discharge, all participants will complete 7 days/6 nights At-Home Period using the AID+InsuLearn-SMA system before returning the study equipment. The INSPIRE Questionnaire will be administered before and after the Hotel Admission. Additionally, participants will be asked to provide a 2-week CGM data download of their usual care for statistical analysis before randomization and after returning the equipment.
- Conditions
- Type 1 Diabetes
- Being tested
- AID + InsuLearn-SMA, AID + CC
- Keywords
- Type 1 Diabetes (T1D), Automated Insulin Delivery (AID), Continuous Glucose Monitor (CGM), Diabetes Assistant (DiAs), Carbohydrate Counting (CC), Simplified Meal Announcement (SMA)
- 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.
AID + InsuLearn-SMADevice
Automated insulin delivery (AID) system with InsuLearn simplified meal announcement bolus calculator
AID + CCDevice
Automated insulin delivery (AID) system using usual carbohydrate counting bolus calculator
| Study group | Role | What they receive |
|---|---|---|
| AID + InsuLearn-SMA | Experimental | Participant will use their Automated insulin delivery (AID) system [insulin pump] along with InsuLearn simplified meal announcement bolus calculator Receives: Device: AID + InsuLearn-SMA |
| Carbohydrate Counting | Placebo comparator | Participant will use their Automated insulin delivery (AID) system [insulin pump] and their usual carbohydrate counting bolus calculator Receives: Device: AID + CC |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIR (70-180 mg/dL)
The primary outcome will be the CGM-measured time in range (TIR, 70-180 mg/dL) during the hotel portion.
Measured: 18 hours
Secondary outcomes (1)
TIR (70-180 mg/dL)
The primary outcome will be the CGM-measured time in range (TIR, 70-180 mg/dL) during the at-home period.
Measured: 1-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start3 Mar 2026
- Primary completion14 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melissa J. Schoelwer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melissa J. Schoelwer, University of Virginia
- Investigators
- Melissa Schoelwer, MD, Principal investigator, University of Virginia School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212179
- Sponsor's protocol ID
- 302850
- Acronym
- InsuLearn-SMA
- Status last verified
- May 2026
- First submitted
- 29 Sep 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 Diabetes Using Automated Insulin Delivery
- ClinicalTrials.gov ID
- NCT07212179
- Acronym / sponsor ID
- InsuLearn-SMA / 302850
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes (T1D), Automated Insulin Delivery (AID), Continuous Glucose Monitor (CGM), Diabetes Assistant (DiAs), Carbohydrate Counting (CC), Simplified Meal Announcement (SMA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Melissa J. SchoelwerUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 8 Oct 2025 (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.
To evaluate the safety and feasibility of a novel self-learning bolus calculator along with simplified meal announcement (AID+InsuLearn-SMA) in adolescents and young adults with T1D using Automated Insulin Delivery.
Detailed description
Following recruitment and screening, participants will be randomized to one of two sequences during the Hotel Admission: AID+InsuLearn-SMA→AID+CC or AID+CC→AID+InsuLearn-SMA. All participants will be trained on the study equipment, which includes (i) the DiAs smartphone running the Control-IQ algorithm with either the InsuLearn-SMA bolus calculator or the standard carbohydrate counting bolus calculator, and (ii) the Dexcom CGM. All participants will complete 7 days/6 nights run-in At-Home Period using the AID+CC system (Control-IQ with the standard carbohydrate counting bolus calculator). Participants will then undergo a 2-night supervised hotel admission (approximately 48 hours). During this admission, each participant will consume two standardized meals (dinner and breakfast), during which either the InsuLearn-SMA bolus calculator or the standard CC bolus calculator will be used in a randomized order. Two lunches will be offered during the Hotel Admission but not included in the analysis. Following discharge, all participants will complete 7 days/6 nights At-Home Period using the AID+InsuLearn-SMA system before returning the study equipment. The INSPIRE Questionnaire will be administered before and after the Hotel Admission. Additionally, participants will be asked to provide a 2-week CGM data download of their usual care for statistical analysis before randomization and after returning the equipment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AID + InsuLearn-SMA | Experimental | Device: AID + InsuLearn-SMAParticipant will use their Automated insulin delivery (AID) system [insulin pump] along with InsuLearn simplified meal announcement bolus calculator |
| Carbohydrate Counting | Placebo comparator | Device: AID + CCParticipant will use their Automated insulin delivery (AID) system [insulin pump] and their usual carbohydrate counting bolus calculator |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- Age ≥14.0 and ≤21 years old at time of consent
- HbA1c ≤ 10%.
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
- Having used an insulin pump within the last three months.
- Currently using insulin for at least six months
Key exclusion criteria (13 listed)
- History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- Pregnancy or intent to become pregnant during the trial
- Currently breastfeeding or planning to breastfeed
- Currently being treated for a seizure disorder
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 |
|---|---|---|
| AID + InsuLearn-SMAAutomated insulin delivery (AID) system with InsuLearn simplified meal announcement bolus calculator | Device | AID + InsuLearn-SMA |
| AID + CCAutomated insulin delivery (AID) system using usual carbohydrate counting bolus calculator | Device | Carbohydrate Counting |
Primary outcome
TIR (70-180 mg/dL)
Time frame: 18 hours
The primary outcome will be the CGM-measured time in range (TIR, 70-180 mg/dL) during the hotel portion.
1 secondary outcome
TIR (70-180 mg/dL)
Time frame: 1-week
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 11 May 2026.
Related trials for Type 1 Diabetes
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.
Melissa Schoelwer, MD principal investigator
University of Virginia School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AID + InsuLearn-SMA and AID + CC in people with Type 1 Diabetes, run by Melissa J. Schoelwer at 1 site 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 15 inclusion and 13 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 11 May 2026. 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 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. Some participants in this study may receive a placebo. 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?
TIR (70-180 mg/dL) (time frame: 18 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2026.