Type 2 Diabetes Treated With InsulinLISA PilotNCT03980236
Feasibility of Using the Livongo-Insulia Study App for Patients With Type 2 Diabetes [Pilot Study]
A study testing Livongo-Insulia Study App in people with Type 2 Diabetes Treated With Insulin, run by Livongo Health at 1 site in United States.
Trial summary
The Livongo-Insulia Study App Pilot Study (LISA Pilot) is a 3-month, prospective, interventional study. The purpose of this pilot study is to evaluate the feasibility of using the Livongo-Insulia Study App for individuals with type 2 diabetes using basal insulin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Treated With Insulin
- What is being tested?
- Livongo-Insulia Study App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2019to 31 May 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Lives in the U.S.
- Able to speak, read and write in English
- Diagnosed with type 2 diabetes
- Currently treated with long-acting basal insulin analog (Lantus, Levemir, Toujeo, Basaglar, Tresiba U-100) and taking 1 injection per day
- Takes a daily dose ≤ 0.75 units/kg
Show all 12Show fewer
- Estimated A1c ≥ 8% (based on existing Livongo data)
- Has been enrolled in Livongo for at least 12 weeks
- Uses an iPhone compatible with Insulia's compatibility matrix (iPhone 5 or higher; iOS 8 or newer)
- Willing to complete study questionnaires
- Willing to complete at-home A1c kits
- Willing to check before breakfast blood glucose at least once per day
Who cannot join
- Diagnosis of type 1 diabetes
- Currently using a long-acting basal insulin analog that is not supported by Insulia
- Currently using rapid-acting, short-acting, or intermediate-acting or premixed insulins
- Currently pregnant or planning pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Using the Insulia App in an Integrated Platform With Livongo for Patients With Type 2 Diabetes Treated With Basal Insulin [Pilot Study]
The Livongo-Insulia Study App Pilot Study (LISA Pilot) is a 3-month, prospective, interventional study. The purpose of this pilot study is to evaluate the feasibility of using the Livongo-Insulia Study App for individuals with type 2 diabetes using basal insulin. This will be assessed by measuring the impact of the Livongo-Insulia Study App on glycemic control for these individuals.
- Conditions
- Type 2 Diabetes Treated With Insulin
- Being tested
- Livongo-Insulia Study App
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Livongo-Insulia Study AppDevice
Throughout the study, participants will be asked to use the LIvongo-Insulia Study App daily to receive their basal insulin dose recommendation. Participants will need to check their before breakfast blood glucose using their Livongo meter. Then, they will need to open the Livongo-Insulia Study App and accept the uploaded blood glucose(s) from the Livongo meter. Once the appropriate information is received, participants will receive an insulin dose recommendation and should confirm once the dose has been taken. Depending on their blood glucose, participants may also receive coaching messages and coaching support from the Livongo program.
| Study group | Role | What they receive |
|---|---|---|
| Livongo-Insulia Study App Arm | Experimental | Participants will be asked to use the Livong-Insulia Study App for the 3 month study duration Receives: Device: Livongo-Insulia Study App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in A1c
Change in A1c from baseline to 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start6 May 2019
- Primary completion27 Feb 2020
- Study completion31 May 2020
Why it stopped: Did not achieve enrollment goal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Treated With InsulinStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Livongo Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Voluntis, Evidation Health
- Responsible party
- Principal investigator, Bimal Shah, MD, Livongo Health
- Investigators
- Bimal Shah, MD, MBA, Principal investigator, Livongo Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980236
- Sponsor's protocol ID
- CP04573.A
- Acronym
- LISA Pilot
- Status last verified
- Feb 2021
- First submitted
- 4 Jun 2019
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Using the Insulia App in an Integrated Platform With Livongo for Patients With Type 2 Diabetes Treated With Basal Insulin [Pilot Study]
- ClinicalTrials.gov ID
- NCT03980236
- Acronym / sponsor ID
- LISA Pilot / CP04573.A
- Conditions
- Type 2 Diabetes Treated With Insulin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Did not achieve enrollment goal
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Livongo HealthIndustry (pharma, biotech, devices)
- Collaborators
- Voluntis, Evidation Health
- Study start
- 6 May 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 10 Jun 2019 (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 Livongo-Insulia Study App Pilot Study (LISA Pilot) is a 3-month, prospective, interventional study. The purpose of this pilot study is to evaluate the feasibility of using the Livongo-Insulia Study App for individuals with type 2 diabetes using basal insulin. This will be assessed by measuring the impact of the Livongo-Insulia Study App on glycemic control for these individuals.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Livongo-Insulia Study App Arm | Experimental | Device: Livongo-Insulia Study AppParticipants will be asked to use the Livong-Insulia Study App for the 3 month study duration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years
- Lives in the U.S.
- Able to speak, read and write in English
- Diagnosed with type 2 diabetes
- Currently treated with long-acting basal insulin analog (Lantus, Levemir, Toujeo, Basaglar, Tresiba U-100) and taking 1 injection per day
Key exclusion criteria (4 listed)
- Diagnosis of type 1 diabetes
- Currently using a long-acting basal insulin analog that is not supported by Insulia
- Currently using rapid-acting, short-acting, or intermediate-acting or premixed insulins
- Currently pregnant or planning pregnancy
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 |
|---|---|---|
| Livongo-Insulia Study AppThroughout the study, participants will be asked to use the LIvongo-Insulia Study App daily to receive their basal insulin dose recommendation. Participants will need to check their before breakfast blood glucose using their Livongo meter. Then, they will need to open the Livongo-Insulia Study App and accept the uploaded blood glucose(s) from the Livongo meter. Once the appropriate information is received, participants will receive an insulin dose recommendation and should confirm once the dose has been taken. Depending on their blood glucose, participants may also receive coaching messages and coaching support from the Livongo program. | Device | Livongo-Insulia Study App Arm |
Primary outcome
Change in A1c
Time frame: 12 weeks
Change in A1c from baseline to 12 weeks
Results and safety
The study was stopped early (reason given: Did not achieve enrollment goal). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 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.
Bimal Shah, MD, MBA principal investigator
Livongo Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Livongo-Insulia Study App in people with Type 2 Diabetes Treated With Insulin, run by Livongo Health 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 4 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: stopped early, as of the sponsor's last update on 18 Feb 2021. 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 was stopped early (reason given: Did not achieve enrollment goal). Results are not available in the source record.
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 in A1c (time frame: 12 weeks). 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 18 Feb 2021.