Type 1 Diabetes MellitusNCT03804983
Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin
A study testing Hybrid Closed Loop (HCL) in people with Type 1 Diabetes Mellitus, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this proposed study is to assess the use of a new feature of the Control-IQ system, MyTDI. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Hybrid Closed Loop (HCL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 16 Feb 2019
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Criteria for documented hyperglycemia (at least 1 must be met):
- Clinical diagnosis of type 1 diabetes (C-peptide levels and antibody determinations are not required)
- Diagnosis of type 1 diabetes is based on the investigator's judgement
- Criteria for requiring insulin at diagnosis (both criteria must be met):
- Daily insulin therapy for ≥ 6 months
- Insulin pump therapy for ≥ 3 months
Show all 12Show fewer
- Age 12-18 years
- Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra). If using glulisine, subject must be willing to switch to lispro or aspart.
- Treatment with any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas, and naturaceuticals) is permitted if stable on current dose for at least 1 month.
- Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study.
- For females, not pregnant or breastfeeding. Female subjects who are sexually active should agree to use birth control during the study.
- Total daily insulin dose (TDD) at least 10 U/day.
Who cannot join
- Diabetic ketoacidosis in the past 6 months
- Hypoglycemic seizure or loss of consciousness in the past 6 months
- History of seizure disorder
- History of any heart disease including coronary artery disease, heart failure, or arrhythmias
- History of altitude sickness
- Chronic pulmonary conditions that could impair oxygenation
Show all 16Show fewer
- Cystic fibrosis
- Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgement of the investigator, would be a contraindication to participation in the study.
- History of ongoing renal disease (other than microalbuminuria).
- Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir, or Glargine).
- Pregnancy
- Presence of a febrile illness within 24 hours of the Ski Admission
- Medical or psychiatric conditions that in the judgement of the investigator might interfere with the completion of the protocol such as:
- Inpatient psychiatric treatment in the past 6 months
- Uncontrolled adrenal insufficiency
- Alcohol abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
About this study
The purpose of this proposed study is to assess the use of a new feature of the Control-IQ system, MyTDI.
Read the detailed description
This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) system t:slim X2 with Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1 diabetes.
Once deemed eligible, participants and their parent(s) will be trained on the use of the Tandem t:slim X2 insulin pump with Control-IQ technology and the study Dexcom G6 system. Participants will then use the this study equipment with their home insulin parameters at home for at home for 5 days. Participants will then come to the ski resort to participate in a 72-hour ski admission. Upon arrival, each participant will be randomized to either the using the Control-IQ system with their usual insulin parameters during the ski study and the at-home 5 days at home study or using the MyTDI insulin parameters during the ski study and the at-home 5 days at home study. Study duration for each participant will require 5 study visits over about 2 weeks.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Hybrid Closed Loop (HCL), Control-IQ with MyTDI
- Keywords
- Artificial Pancreas (AP), Insulin Pump, Continuous Glucose Monitor (CGM), MyTDI, Hybrid Closed Loop (HCL), Total Daily Insulin (TDI)
- 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.
Hybrid Closed Loop (HCL)Device
Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
Control-IQ with MyTDIDevice
Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Closed Loop (HCL) | Active comparator | Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home. Receives: Device: Hybrid Closed Loop (HCL) |
| Control-IQ with MyTDI | Experimental | Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used. Receives: Device: Control-IQ with MyTDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Time in Range at Home Pre/Post Intervention at Home
The primary outcome for this study is the percent of time spent between 70mg/dL and 180mg/dL as computed by the number of CGM values falling in this interval divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Measured: 5 days post camp (home) compared to 5 days before camp (baseline)
Secondary outcomes (24)
Average CGM at Home
Average of available CGM values within time frame
Measured: 5 days post camp (home) compared to 5 days before camp (baseline)
Average CGM at Camp
average of CGM values within time frame
Measured: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
Percentage of CGM Values Below 50mg/dL at Home
the percentage of CGM values falling below 50mg/dL, calculated as the number of CGM values <50mg/dL within the time frame divided by the total number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Measured: 5 days post camp (home) compared to 5 days before camp (baseline)
Percentage of CGM Values Below 50mg/dL at Camp
the percentage of CGM values falling below 50mg/dL, computed as the number of CGM values <50mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Measured: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)
Percentage of CGM Values Below 54mg/dL at Camp
the percentage of CGM values falling below 54mg/dL. computed as the number of CGM values <54mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Measured: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
Percentage of CGM Values Below 60mg/dL at Home
the percentage of CGM values falling below 60mg/dL. computed as the number of CGM values <60mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Measured: 5 days post camp (home) compared to 5 days before camp (baseline)
Percentage of CGM Values Below 60mg/dL at Camp
the percentage of CGM values falling below 60mg/dL. computed as the number of CGM values <60mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Measured: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)
Percentage of CGM Values Below 70mg/dL at Home
the percentage of CGM values falling below 70mg/dL, computed as the number of CGM values <70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Measured: 5 days post camp (home) compared to 5 days before camp (baseline)
Percentage of CGM Values Below 70mg/dL at Camp
the percentage of CGM values falling below 70mg/dL, computed as the number of CGM values <70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Measured: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)
Percentage of CGM Values Between 70mg/dL and 180mg/dL at Camp
the percentage of CGM values falling between 70mg/dL and 180mg/dL, computed as the number of CGM values <=180mg/dL and >70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Measured: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
Percentage of CGM Values Above 180mg/dL at Home
the percentage of CGM values falling above 180mg/dL, computed as the number of CGM values >180mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Measured: 5 days post camp (home) compared to 5 days before camp (baseline)
Percentage of CGM Values Above 180mg/dL at Camp
the percentage of CGM values falling above 180mg/dL, computed as the number of CGM values >180mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Measured: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
Percentage of CGM Values Above 250mg/dL at Home
the percentage of CGM values falling above 250mg/dL, computed as the number of CGM values >250mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Measured: 5 days post camp (home) compared to 5 days before camp (baseline)
Percentage of CGM Values Above 250mg/dL at Camp
the percentage of CGM values falling above 250mg/dL, computed as the number of CGM values >250mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Measured: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
Percentage of CGM Values Above 300mg/dL at Home
the percentage of CGM values falling above 300mg/dL, computed as the number of CGM values >300mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Measured: 5 days post camp (home) compared to 5 days before camp (baseline)
Percentage of CGM Values Above 300mg/dL at Camp
the percentage of CGM values falling above 300mg/dL, computed as the number of CGM values >300mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Measured: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
Change in Total Daily Insulin at Home
sum of the recorded insulin injection over the time frame in units
Measured: 5 days post camp (home) compared to 5 days before camp (baseline)
Change in Total Daily Insulin at Camp
sum of the recorded insulin injection over the time frame in units
Measured: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
Change in Total Meal Carbohydrates at Home
sum of the meal sized recorded over the time frame
Measured: 5 days post camp (home) compared to 5 days before camp (baseline)
Change in Total Meal Carbohydrates at Camp
sum of the meal sized recorded over the time frame
Measured: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)
Change in Number of Hypoglycemic Events at Camp
Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL)
Measured: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)
Number of Hypoglycemia Treatment at Camp
Sum of the number of CHO treatments recorded over the time frame
Measured: 2 days during camp admission (Camp)
Total Amount of Carbohydrates Corresponding to Hypoglycemia Treatment at Camp
Sum of the amount of carbohydrates used for treatments recorded over the time frame
Measured: 2 days during camp admission (Camp)
Change in Hypoglycemia Events at Home
change in number of hypoglycemia between baseline and home
Measured: 5 days post camp (home) compared to 5 days before camp (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start15 Jan 2019
- Primary completion16 Feb 2019
- Study completion16 Feb 2019
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 (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) System t:slim X2 with Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1 diabetes.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Tandem Diabetes Care, Inc., DexCom, Inc.
- Responsible party
- Principal investigator, Marc Breton, University of Virginia
- Investigators
- Marc D. Breton, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804983
- Sponsor's protocol ID
- 180030
- Status last verified
- Jul 2024
- First submitted
- 11 Jan 2019
- Last updated
- 1 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
Publications
Schoelwer MJ, Robic JL, Gautier T, Fabris C, Carr K, Clancy-Oliveri M, Brown SA, Anderson SM, DeBoer MD, Chernavvsky DR, Breton MD. Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Based on Total Daily Insulin in Adolescents with Type 1 Diabetes. Diabetes Technol Ther. 2020 Aug;22(8):594-601. doi: 10.1089/dia.2019.0471. Epub 2020 Mar 2.
PubMed 32119790
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin
- ClinicalTrials.gov ID
- NCT03804983
- Acronym / sponsor ID
- 180030
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Artificial Pancreas (AP), Insulin Pump, Continuous Glucose Monitor (CGM), MyTDI, Hybrid Closed Loop (HCL), Total Daily Insulin (TDI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Tandem Diabetes Care, Inc., DexCom, Inc.
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 16 Feb 2019 (actual)
- Study completion
- 16 Feb 2019 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Posted 1 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this proposed study is to assess the use of a new feature of the Control-IQ system, MyTDI.
Detailed description
This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) system t:slim X2 with Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1 diabetes.
Once deemed eligible, participants and their parent(s) will be trained on the use of the Tandem t:slim X2 insulin pump with Control-IQ technology and the study Dexcom G6 system. Participants will then use the this study equipment with their home insulin parameters at home for at home for 5 days. Participants will then come to the ski resort to participate in a 72-hour ski admission. Upon arrival, each participant will be randomized to either the using the Control-IQ system with their usual insulin parameters during the ski study and the at-home 5 days at home study or using the MyTDI insulin parameters during the ski study and the at-home 5 days at home study. Study duration for each participant will require 5 study visits over about 2 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) System t:slim X2 with Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1 diabetes.
| Arm | Type | Receives |
|---|---|---|
| Hybrid Closed Loop (HCL) | Active comparator | Device: Hybrid Closed Loop (HCL)Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home. |
| Control-IQ with MyTDI | Experimental | Device: Control-IQ with MyTDIEligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home: * A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day * A single correction factor (CF) of 1650/TDI will be implemented across the whole day * Carbohydrate ratios (CR) will be set at: * 00:00-04:00 CR=450/TDI * 04:00-11:00 CR=360/TDI * 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Criteria for documented hyperglycemia (at least 1 must be met):
- Criteria for requiring insulin at diagnosis (both criteria must be met):
- Age 12-18 years
- Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra). If using glulisine, subject must be willing to switch to lispro or aspart.
- Treatment with any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas, and naturaceuticals) is permitted if stable on current dose for at least 1 month.
Key exclusion criteria (16 listed)
- Diabetic ketoacidosis in the past 6 months
- Hypoglycemic seizure or loss of consciousness in the past 6 months
- History of seizure disorder
- History of any heart disease including coronary artery disease, heart failure, or arrhythmias
- History of altitude sickness
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 |
|---|---|---|
| Hybrid Closed Loop (HCL)Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity. | Device | Hybrid Closed Loop (HCL) |
| Control-IQ with MyTDIParticipants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity. | Device | Control-IQ with MyTDI |
Primary outcome
Percent Time in Range at Home Pre/Post Intervention at Home
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
The primary outcome for this study is the percent of time spent between 70mg/dL and 180mg/dL as computed by the number of CGM values falling in this interval divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
24 secondary outcomes
Average CGM at Home
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
Average CGM at Camp
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
Percentage of CGM Values Below 50mg/dL at Home
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
Percentage of CGM Values Below 50mg/dL at Camp
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)
Percentage of CGM Values Below 54mg/dL at Camp
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
Percentage of CGM Values Below 60mg/dL at Home
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
Percentage of CGM Values Below 60mg/dL at Camp
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)
Percentage of CGM Values Below 70mg/dL at Home
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
Percentage of CGM Values Below 70mg/dL at Camp
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)
Percentage of CGM Values Between 70mg/dL and 180mg/dL at Camp
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
Percentage of CGM Values Above 180mg/dL at Home
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
Percentage of CGM Values Above 180mg/dL at Camp
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
Percentage of CGM Values Above 250mg/dL at Home
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
Percentage of CGM Values Above 250mg/dL at Camp
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
Percentage of CGM Values Above 300mg/dL at Home
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
Percentage of CGM Values Above 300mg/dL at Camp
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
Change in Total Daily Insulin at Home
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
Change in Total Daily Insulin at Camp
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
Change in Total Meal Carbohydrates at Home
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
Change in Total Meal Carbohydrates at Camp
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)
Change in Number of Hypoglycemic Events at Camp
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)
Number of Hypoglycemia Treatment at Camp
Time frame: 2 days during camp admission (Camp)
Total Amount of Carbohydrates Corresponding to Hypoglycemia Treatment at Camp
Time frame: 2 days during camp admission (Camp)
Change in Hypoglycemia Events at Home
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32119790Schoelwer MJ, Robic JL, Gautier T, Fabris C, Carr K, Clancy-Oliveri M, Brown SA, Anderson SM, DeBoer MD, Chernavvsky DR, Breton MD. Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Based on Total Daily Insulin in Adolescents with Type 1 Diabetes. Diabetes Technol Ther. 2020 Aug;22(8):594-601. doi: 10.1089/dia.2019.0471. Epub 2020 Mar 2.
- Individual participant dataSharing planned: Yes. Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
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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.
Marc D. Breton, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Closed Loop (HCL) in people with Type 1 Diabetes Mellitus, run by University of Virginia 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 12 inclusion and 16 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 1 Aug 2024. 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. 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 1 Aug 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?
Percent Time in Range at Home Pre/Post Intervention at Home (time frame: 5 days post camp (home) compared to 5 days before camp (baseline)). 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 NCT03804983, 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 1 Aug 2024.