Type 1 DiabetesNCT04667182
A Study of Glucose Control in Participants With Type 1 and Type 2 Diabetes
An observational study of Type 1 Diabetes and Type 2 Diabetes, run by Eli Lilly and Company at 2 sites 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 (T1D) and type 2 diabetes (T2D). No study drug will be given. The study will last about 18 weeks. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- Meal-Tagging App and Web-based Portal: and Fitness Tracker
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jan 2021to 6 Dec 2021
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with T1D and T2D
Who may be able to join
- Individuals with type 1 or type 2 diabetes for >3 years by clinical diagnosis who use basal insulin, in addition to at least one injection of meal time insulin per day
- Insulin pen use for at least 3 months
- Current use of or willingness to use Dexcom G6 at least 6 out of 7 days per week
- A1c 6.5-9.5%
Who cannot join
- Currently using any form of insulin pump, including hybrid closed-loop system (e.g., Medtronic 670G)
- Individuals requiring single insulin boluses of >40 units
- Individuals planning to follow a specific diet plan for weight loss
- Inability to consume regular, consistent meals
- Individuals who have had severe hypoglycemia with seizure or coma within the past 6 months
- Individuals who have been hospitalized for diabetic ketoacidosis (DKA) within the past 6 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Medical Center
Boston, Massachusetts, 02118
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Meal-centric Insulin Dosing for Optimized Post-Prandial Glucose Control in People Using Multiple Daily Injections
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 (T1D) and type 2 diabetes (T2D). No study drug will be given. The study will last about 18 weeks.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- Meal-Tagging App and Web-based Portal:, Fitness Tracker
- Keywords
- T1D, T2D
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal-Tagging App and Web-based Portal:Other
Meal tagging app to capture frequently eaten meals and test meals for 18 weeks.
Fitness TrackerDevice
Fitness tracker will be worn around the clock for 18 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Combined Diabetes Management Data | Participants with type 1 and type 2 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 insulin pen and continuous glucose monitor (CGM). Combined data will be used as a complement to standard of care for diabetes management. Receives: Other: Meal-Tagging App and Web-based Portal:; Device: Fitness Tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Area Under the Curve (AUC) of CGM
Change from Baseline in AUC of CGM
Measured: Baseline, Week 17
Secondary outcomes (5)
Qualitative data from study investigators and participants
Qualitative data describing experience from study investigators and participants
Measured: Baseline through Week 17
Percent Time-in-Range (TIR)
Percent Time-in-Range defined as glucose >70 and ≤180 milligrams per deciliter [mg/dL])
Measured: Baseline through Week 17
Postprandial TIR
Postprandial TIR is defined as TIR glucose: glucose >=70 and ≤180 mg/dL
Measured: Baseline through Week 17
Time Above Range (TAR)
TAR is defined as glucose > 180 mg/dL
Measured: Baseline through Week 17
Time Below Range (TBR) <70 mg/dL
TBR is defined as glucose < 70 mg/dL
Measured: Baseline through Week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start25 Jan 2021 (estimated)
- Primary completion6 Dec 2021 (estimated)
- Study completion6 Dec 2021 (estimated)
Why it stopped: Study was withdrawn prior to enrolment due to business decision.
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.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- NCT04667182
- Sponsor's protocol ID
- 17420
- Other IDs
- F3Z-MC-IORN
- Status last verified
- Sep 2021
- First submitted
- 11 Dec 2020
- Last updated
- 17 Sep 2021
- 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 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meal-centric Insulin Dosing for Optimized Post-Prandial Glucose Control in People Using Multiple Daily Injections
- ClinicalTrials.gov ID
- NCT04667182
- Acronym / sponsor ID
- 17420
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Keywords
- T1D, T2D
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn prior to enrolment due to business decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2021 (estimated)
- Primary completion
- 6 Dec 2021 (estimated)
- Study completion
- 6 Dec 2021 (estimated)
- First posted
- 14 Dec 2020 (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 (T1D) and type 2 diabetes (T2D). 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 and Web-based Portal:, Device: Fitness TrackerParticipants with type 1 and type 2 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 insulin pen and continuous glucose monitor (CGM). Combined data will be used as a complement to standard of care for diabetes management. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with T1D and T2D
Key inclusion criteria (4 listed)
- Individuals with type 1 or type 2 diabetes for >3 years by clinical diagnosis who use basal insulin, in addition to at least one injection of meal time insulin per day
- Insulin pen use for at least 3 months
- Current use of or willingness to use Dexcom G6 at least 6 out of 7 days per week
- A1c 6.5-9.5%
Key exclusion criteria (6 listed)
- Currently using any form of insulin pump, including hybrid closed-loop system (e.g., Medtronic 670G)
- Individuals requiring single insulin boluses of >40 units
- Individuals planning to follow a specific diet plan for weight loss
- Inability to consume regular, consistent meals
- Individuals who have had severe hypoglycemia with seizure or coma within the past 6 months
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 App and Web-based Portal:Meal tagging app to capture frequently eaten meals and test meals for 18 weeks. | Other | Combined Diabetes Management Data |
| Fitness TrackerFitness tracker will be worn around the clock for 18 weeks. | Device | Combined Diabetes Management Data |
Primary outcome
Change from Baseline in Area Under the Curve (AUC) of CGM
Time frame: Baseline, Week 17
Change from Baseline in AUC of CGM
5 secondary outcomes
Qualitative data from study investigators and participants
Time frame: Baseline through Week 17
Percent Time-in-Range (TIR)
Time frame: Baseline through Week 17
Postprandial TIR
Time frame: Baseline through Week 17
Time Above Range (TAR)
Time frame: Baseline through Week 17
Time Below Range (TBR) <70 mg/dL
Time frame: Baseline through Week 17
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Type 2 Diabetes, run by Eli Lilly and Company at 2 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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study was withdrawn before enrolling participants, so there are no results.
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 in Area Under the Curve (AUC) of CGM (time frame: Baseline, Week 17). 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 17 Sep 2021.