Diabetes Mellitus, Type 1NCT03758430
A Study of Technology to Improve Glucose Control in Participants With Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The main purpose of this study is to determine whether combining meal, glucose, and insulin data in a web-based system will improve management of type 1 diabetes (T1D). No study drug will be given. The study will last about 18 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Meal-Tagging App and Fitness Tracker
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2019to 7 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with T1D
Who may be able to join
- T1D by clinical diagnosis for > 3 years
- Insulin pump use > 3 months: must use one of the following pump types: Animas Ping and Vibe, Insulet Omnipod, Medtronic 523/723 and 530G, Tandem t:slim and t:flex
- Continuous Glucose Monitor (CGM) > 3 months and current use of Dexcom G5 at least 6 out of 7 days per week
- HbA1c 7.0-9.5%
- Must have iPhone (meal-tagging app has been built on iOS)
- Personal computer for uploading of pump and CGM devices
- Willingness to follow study protocol including tagging food data
- Comfort speaking, reading, and writing English
Who cannot join
- Individuals currently using a hybrid closed-loop system (e.g., Medtronic 670G)
- Individuals planning to follow a specific diet plan for weight loss
- Inability to consume "common meals"
- Gastroparesis;
- Eating disorder
- Evidence of missed insulin meal-time insulin boluses on pump download
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- Use of medications that can affect blood glucose levels (such as SGLT inhibitors, steroid, beta agonists)
- Use of medications that affect gastric emptying (such as GLP agonists, pramlinitide)
- Alcohol abuse
- Pre-conception, pregnancy, or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technology-supported, Meal-centric, Insulin Dosing for Optimized Post-prandial Glucose Control
The main purpose of this study is to determine whether combining meal, glucose, and insulin data in a web-based system will improve management of type 1 diabetes (T1D). No study drug will be given. The study will last about 18 weeks.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Meal-Tagging App, Fitness Tracker
- 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.
Meal-Tagging AppOther
Meal tagging app to capture frequently eaten meals and test meals for 16 weeks.
Fitness TrackerDevice
Fitness tracker will be worn around the clock for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Combined Diabetes Management Data | Participants with type 1 diabetes will use a meal tagging application (app) and fitness tracker. They will upload these data to a web portal where they will be matched with data from their continuous glucose monitor and insulin pump. Combined data will be used for diabetes management. Receives: Other: Meal-Tagging App; Device: Fitness Tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 16 in Hemoglobin A1c (HbA1c)
Change from Baseline to Week 16 in HbA1c
Measured: Baseline to Week 16
Secondary outcomes (1)
Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals
Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start6 Feb 2019
- Primary completion7 Aug 2020
- Study completion7 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Joslin Diabetes Center
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758430
- Sponsor's protocol ID
- 17111
- Other IDs
- F3Z-MC-IORA
- Status last verified
- Aug 2020
- First submitted
- 27 Nov 2018
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-supported, Meal-centric, Insulin Dosing for Optimized Post-prandial Glucose Control
- ClinicalTrials.gov ID
- NCT03758430
- Acronym / sponsor ID
- 17111
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Joslin Diabetes Center
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 7 Aug 2020 (actual)
- Study completion
- 7 Aug 2020 (actual)
- First posted
- 29 Nov 2018 (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.
The main purpose of this study is to determine whether combining meal, glucose, and insulin data in a web-based system will improve management of type 1 diabetes (T1D). No study drug will be given. The study will last about 18 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined Diabetes Management Data | – | Other: Meal-Tagging App, Device: Fitness TrackerParticipants with type 1 diabetes will use a meal tagging application (app) and fitness tracker. They will upload these data to a web portal where they will be matched with data from their continuous glucose monitor and insulin pump. Combined data will be used for diabetes management. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with T1D
Key inclusion criteria (8 listed)
- T1D by clinical diagnosis for > 3 years
- Insulin pump use > 3 months: must use one of the following pump types: Animas Ping and Vibe, Insulet Omnipod, Medtronic 523/723 and 530G, Tandem t:slim and t:flex
- Continuous Glucose Monitor (CGM) > 3 months and current use of Dexcom G5 at least 6 out of 7 days per week
- HbA1c 7.0-9.5%
- Must have iPhone (meal-tagging app has been built on iOS)
Key exclusion criteria (10 listed)
- Individuals currently using a hybrid closed-loop system (e.g., Medtronic 670G)
- Individuals planning to follow a specific diet plan for weight loss
- Inability to consume "common meals"
- Gastroparesis;
- Eating 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 |
|---|---|---|
| Meal-Tagging AppMeal tagging app to capture frequently eaten meals and test meals for 16 weeks. | Other | Combined Diabetes Management Data |
| Fitness TrackerFitness tracker will be worn around the clock for 16 weeks. | Device | Combined Diabetes Management Data |
Primary outcome
Change from Baseline to Week 16 in Hemoglobin A1c (HbA1c)
Time frame: Baseline to Week 16
Change from Baseline to Week 16 in HbA1c
1 secondary outcome
Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals
Time frame: Baseline to Week 16
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 21 Aug 2020.
- 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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by Eli Lilly and Company 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 8 inclusion and 10 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 21 Aug 2020. 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?
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?
Change from Baseline to Week 16 in Hemoglobin A1c (HbA1c) (time frame: Baseline to Week 16). 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 21 Aug 2020.