Type 1 DiabetesNCT02835183
Evaluation of iDECIDE: A Smartphone App for Insulin Dosing Accounting for Alcohol and Exercise
A study testing iDECIDE and Insulin pump in people with Type 1 Diabetes, run by Arizona State University.
Trial summary
The investigators propose a randomized cross-over study Phase 1 Clinical trial. 30 type 1 diabetes adult outpatients using insulin pumps and continuous glucose monitoring system will be recruited from the Endocrinology Clinic at the Mayo Clinic Arizona. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- iDECIDE and Insulin pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Oct 2017
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mayo Clinic Arizona type 1 diabetes outpatients,
- Older than 18 years and younger than 60,
- Non-pregnant,
- English speakers,
- Who use Medtronic insulin pumps and continuous glucose monitoring sensors,
- Own a smartphone,
- Have kept in consistent contact with the Mayo Clinic Division of Endocrinology health care team during the last year, and have use the same insulin pump and continuous glucose sensor for at least one year.
Who cannot join
- Subjects who do not satisfy the inclusion criteria.
About this study
Official title: Prospective Evaluation of iDECIDE: A Smartphone App for Insulin Bolus Dosing
The investigators propose a randomized cross-over study Phase 1 Clinical trial. 30 type 1 diabetes adult outpatients using insulin pumps and continuous glucose monitoring system will be recruited from the Endocrinology Clinic at the Mayo Clinic Arizona. Participants will be randomly assigned to 4 weeks of using their pump bolus wizards to decide insulin boluses and then 4 wks of using iDECIDE to receive recommendations for insulin dosing, or vice versa. The primary outcomes to compare iDECIDE's insulin dosing algorithm against the pump calculators will be: mean postprandial glucose level and number of events with excessive blood glucose highs and lows.
Read the detailed description
The investigators will seek approval from Mayo Clinic and Arizona State University Institutional Review Board to recruit 30 type 1 diabetes adult outpatients using insulin pumps and continuous glucose monitoring system from the Endocrinology Clinic at Mayo Clinic Arizona. First, participants will complete a questionnaire to self-assess their confidence to count carbs from food/drinks, personal perceptions on how exercise/alcohol affect their blood glucose, and how they learned about it (e.g., trial and error, education from providers), and compensation techniques used to adjust for exercise performed/alcohol consumed (for instance, adjust for basal rate or adjust insulin boluses). Stored glucose data will be analyzed for the previous 8 weeks prior to entry to establish patient-specific upper and lower bounds for determining excessive blood glucose highs and lows. Second, participants will be randomly assigned to 4 weeks of using their pump bolus wizards to decide insulin boluses and then 4 weeks of using iDECIDE to receive recommendations for insulin dosing, or vice versa. Throughout the 8 weeks, study participants will be asked to wear a wristband heart rate accelerometer that will provide data on time and duration of exercise performed. Also, during the 8 weeks, study participants will use their glucose sensor and pump to measure blood glucose and to deliver basal insulin. During the 4 weeks when participants receive recommendations from iDECIDE, the pump's bolus calculator will be turned off so participants will receive no insulin bolus recommendations from pump. While receiving recommendations from iDECIDE, participants will use the pump to manually deliver insulin boluses and can either use the advice from iDECIDE or override it.
The primary outcomes to compare iDECIDE's insulin dosing algorithm against the pump calculators will be: mean postprandial glucose level and number of events with excessive blood glucose highs and lows. Potential secondary outcomes: mean percentage of time with low glucose level and time spent in the target glucose range.
- Conditions
- Type 1 Diabetes
- Being tested
- iDECIDE, Insulin pump
- 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.
iDECIDEDevice
The iDECIDE app will be installed in study participant's smartphone. The app requests from study participants input on food consumed (included food's carbohydrate content), alcohol consumed (included alcohol's carbohydrate content) and exercise plans (including duration and intensity). Based on that input the app suggests insulin bolus dosing.
Insulin pumpDevice
Study participants will use during the study their own insulin pump and continuous glucose sensor. As inclusion criteria, investigators expect study participants to have been using their insulin pump and continuous glucose sensor for at least one year.
| Study group | Role | What they receive |
|---|---|---|
| Insulin pump followed by iDECIDE | Experimental | Participants will be randomly assigned to 4 weeks of using their insulin pump to decide insulin boluses and then 4 weeks of using iDECIDE to receive recommendations for insulin dosing. Receives: Device: iDECIDE; Device: Insulin pump |
| iDECIDE followed by insulin pump | Experimental | Participants will be randomly assigned to 4 weeks of using iDECIDE to receive recommendations for insulin dosing and then 4 weeks of using their insulin pump to decide insulin boluses. Receives: Device: iDECIDE; Device: Insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare mean postprandial glucose level
Compare iDECIDE's insulin dosing algorithm against the pump calculators in terms of mean postprandial glucose level
Measured: 2 months
Secondary outcomes (2)
Hypoglycemia events
% time with blood glucose < 3.9 mmol/L
Measured: 2 months
Hyperglycemia events
% time with blood glucose > 8.0 mmol/L
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startJan 2017
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
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 Arizona State UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Principal investigator, Adela Grando, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835183
- Sponsor's protocol ID
- iDECIDEEvaluation
- Status last verified
- Dec 2019
- First submitted
- 6 Jun 2016
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of iDECIDE: A Smartphone App for Insulin Bolus Dosing
- ClinicalTrials.gov ID
- NCT02835183
- Acronym / sponsor ID
- iDECIDEEvaluation
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- Jan 2017
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 15 Jul 2016 (estimated)
- 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 investigators propose a randomized cross-over study Phase 1 Clinical trial. 30 type 1 diabetes adult outpatients using insulin pumps and continuous glucose monitoring system will be recruited from the Endocrinology Clinic at the Mayo Clinic Arizona. Participants will be randomly assigned to 4 weeks of using their pump bolus wizards to decide insulin boluses and then 4 wks of using iDECIDE to receive recommendations for insulin dosing, or vice versa. The primary outcomes to compare iDECIDE's insulin dosing algorithm against the pump calculators will be: mean postprandial glucose level and number of events with excessive blood glucose highs and lows.
Detailed description
The investigators will seek approval from Mayo Clinic and Arizona State University Institutional Review Board to recruit 30 type 1 diabetes adult outpatients using insulin pumps and continuous glucose monitoring system from the Endocrinology Clinic at Mayo Clinic Arizona. First, participants will complete a questionnaire to self-assess their confidence to count carbs from food/drinks, personal perceptions on how exercise/alcohol affect their blood glucose, and how they learned about it (e.g., trial and error, education from providers), and compensation techniques used to adjust for exercise performed/alcohol consumed (for instance, adjust for basal rate or adjust insulin boluses). Stored glucose data will be analyzed for the previous 8 weeks prior to entry to establish patient-specific upper and lower bounds for determining excessive blood glucose highs and lows. Second, participants will be randomly assigned to 4 weeks of using their pump bolus wizards to decide insulin boluses and then 4 weeks of using iDECIDE to receive recommendations for insulin dosing, or vice versa. Throughout the 8 weeks, study participants will be asked to wear a wristband heart rate accelerometer that will provide data on time and duration of exercise performed. Also, during the 8 weeks, study participants will use their glucose sensor and pump to measure blood glucose and to deliver basal insulin. During the 4 weeks when participants receive recommendations from iDECIDE, the pump's bolus calculator will be turned off so participants will receive no insulin bolus recommendations from pump. While receiving recommendations from iDECIDE, participants will use the pump to manually deliver insulin boluses and can either use the advice from iDECIDE or override it.
The primary outcomes to compare iDECIDE's insulin dosing algorithm against the pump calculators will be: mean postprandial glucose level and number of events with excessive blood glucose highs and lows. Potential secondary outcomes: mean percentage of time with low glucose level and time spent in the target glucose range.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin pump followed by iDECIDE | Experimental | Device: iDECIDE, Device: Insulin pumpParticipants will be randomly assigned to 4 weeks of using their insulin pump to decide insulin boluses and then 4 weeks of using iDECIDE to receive recommendations for insulin dosing. |
| iDECIDE followed by insulin pump | Experimental | Device: iDECIDE, Device: Insulin pumpParticipants will be randomly assigned to 4 weeks of using iDECIDE to receive recommendations for insulin dosing and then 4 weeks of using their insulin pump to decide insulin boluses. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Mayo Clinic Arizona type 1 diabetes outpatients,
- Older than 18 years and younger than 60,
- Non-pregnant,
- English speakers,
- Who use Medtronic insulin pumps and continuous glucose monitoring sensors,
Key exclusion criteria (1 listed)
- Subjects who do not satisfy the inclusion criteria.
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 |
|---|---|---|
| iDECIDEThe iDECIDE app will be installed in study participant's smartphone. The app requests from study participants input on food consumed (included food's carbohydrate content), alcohol consumed (included alcohol's carbohydrate content) and exercise plans (including duration and intensity). Based on that input the app suggests insulin bolus dosing. | Device | Insulin pump followed by iDECIDE, iDECIDE followed by insulin pump |
| Insulin pumpStudy participants will use during the study their own insulin pump and continuous glucose sensor. As inclusion criteria, investigators expect study participants to have been using their insulin pump and continuous glucose sensor for at least one year. | Device | Insulin pump followed by iDECIDE, iDECIDE followed by insulin pump |
Primary outcome
Compare mean postprandial glucose level
Time frame: 2 months
Compare iDECIDE's insulin dosing algorithm against the pump calculators in terms of mean postprandial glucose level
2 secondary outcomes
Hypoglycemia events
Time frame: 2 months
Hyperglycemia events
Time frame: 2 months
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 2 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing iDECIDE and Insulin pump in people with Type 1 Diabetes, run by Arizona State University.
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 7 inclusion and 1 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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Compare mean postprandial glucose level (time frame: 2 months). 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 2 Jan 2020.