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Type 1 Diabetes (T1D)AB-CDENCT07282639

App-Based Certified Diabetes Education Therapy (AB-CDE)

A study testing DailyDose in people with Type 1 Diabetes (T1D), run by Oregon Health and Science University at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to learn more about a smartphone application (app) called DailyDose, an investigational decision support tool that may help in managing your diabetes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes (T1D)
What is being tested?
DailyDose
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
6 sitesUnited States
Study dates
8 Jul 2026to 15 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Diagnosis of type 1 diabetes mellitus for at least 1 year.
  • Age 18 years and older.
  • Able to read, write and understand spoken English
  • HbA1c or GMI 7.5- 11.5% at screening. GMI (%) = 3.31 + 0.02392 × [mean glucose in mg/dL] based on prior 30 days of CGM data with at least 70% time CGM active[6]
  • Use of multiple daily insulin injections (MDI) for at least 30 days at the time of screening visit.
  • Willing to use the approved study insulin and devices while on study - Humalog and Basaglar Tempo pens, Dexcom G6 CGM, study iPhone, Apple watch
  • Willingness and ability to independently follow all study procedures, including attending all clinic and DSMES and behavioral health visits.
  • Total daily insulin requirements of less than 200 units

Who cannot join

  • Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide, and the man uses a condom), or abstinence.
  • History of stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty.
  • Renal insufficiency (GFR < 60 ml/min, using either MDRD** or CKD-EPI# equation as reported by the laboratory).
  • Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.
  • History of severe hypoglycemia during the 3 months prior to screening or hypoglycemia unawareness as judged by the investigator. Participants will complete a hypoglycemia awareness questionnaire. Participants will be excluded for four or more R responses.
  • History of diabetes ketoacidosis during the 3 months prior to screening, as diagnosed on hospital admission or as judged by the investigator.
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  • History of psychiatric admission during the 6 months prior to screening.
  • Adrenal insufficiency.
  • Any active infection.
  • Known or suspected abuse of alcohol, narcotics, or illicit drugs.
  • Uncontrolled seizure disorder.
  • Active foot ulceration.
  • Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
  • Major surgical operation within 30 days prior to screening.
  • Use of an investigational drug within 30 days prior to screening.
  • Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
  • Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
  • Allergy to Humalog or Basaglar insulin.
  • Current chronic administration of oral or parenteral corticosteroids.
  • Any life-threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the 5 years prior to screening (except basal and squamous cell skin cancer).
  • Initiation or titration of any medication used to lower glucose other than insulin in the 6 weeks prior to screening (e.g. metformin or semaglutide). Participants will not be excluded if they are non-insulin glucose lowering medication at a stable dose with no plans for discontinuation or dose modification during the course of the study). A positive response to any of the questions from the Physical Activity Readiness Questionnaire (see Appendix A) with one exception: participant will not be excluded if taking a single blood pressure medication and blood pressure is controlled on the medication (blood pressure is less than 140/90 mmHg).
  • Any chest discomfort with physical activity, including pain or pressure, or other types of discomfort.
  • Gastroparesis.
  • On a very low carbohydrate diet (less than 50g per day)
  • Taking part in another diabetes or obesity-related treatment study.
  • Any clinically significant disease or disorder which, in the opinion of the Investigator, may jeopardize the participant's safety or compliance with the protocol.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Linda Lester, MD contact

503-418-8478

lesterl@ohsu.edu

Samrita Thapa, MPH contact

503-494-8421

thapasa@ohsu.edu

6 sites in 1 country

United States6 sites, 6 recruiting

  • Barbara Davis Center

    Aurora, Colorado, 80045

    Halis Akturk, MD, 303-724-0467, halis.akturk@cuanschutz.edu

    Emma Mason, 303-724-5895, emma.mason@cuanschutz.edu

    Recruiting

  • Joslin Diabetes Center, Harvard School of Medicine

    Boston, Massachusetts, 02215

    Joslin Toschi, MD, 617-309-2440, Elena.Toschi@joslin.harvard.edu

    Christine Slyne, Christine.slyne@joslin.harvard.edu

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Viral Shah, MD, 317-274-7605, shahvi@iu.edu

    Brittany Thorne, 317-278-0532, thorneb@iu.edu

    Recruiting

  • University of Southern California

    Los Angeles, California, 90022

    Anna Peters, MD, 323-362-1320, annepete@med.usc.edu

    Valerie Ruelas, vruelas@usc.edu

    Recruiting

  • Mount Sinai School of Medicine

    New York, New York, 10029

    Carol Levy, MD, 212-241-0068, carol.levy@mssm.edu

    Sarah Rancic, sarah.rancic@mssm.edu

    Recruiting

  • Oregon Health & Science University , Portland

    Portland, Oregon, 97239

    Linda Lester, MD, 503-418-8478, lesterl@ohsu.edu

    Peter Jacobs, PhD

    Recruiting

Other trials in United States

About this study

Official title: Development and Evaluation of App-Based Certified Diabetes Education (AB-CDE) Therapy for People Living With T1D Using MDI

The purpose of this study is to learn more about a smartphone application (app) called DailyDose, an investigational decision support tool that may help in managing your diabetes. DailyDose tracks your continuous glucose monitoring (CGM) data, insulin use, and exercise, and uses this information to provide personalized recommendations for insulin dosing and carbohydrate intake during exercise or low blood sugar events. We want to find out if DailyDose can help lower blood sugar levels as measured by the hemoglobin A1c (HbA1c) test.

Read the detailed description

Participants will be on study for 38 weeks (2-week run-in period and 36 weeks of intervention). Participants will begin the study with a training visit on the Dexcom G6 CGM system, the insulin dose capture system, and the Data-logging Mode of DailyDose. Participants will be provided with Novalog InPens for use with the insulin dose capture system. Participants will also receive an iPhone and Apple smart watch for acquiring sleep metrics and exercise data. Participants will use these devices during the next 14 days at home (2-week run-in). At the end of the run-in, participants will start the intervention. They will be trained at Visit 3 on using the DailyDose system. Participants will then use the DailyDose system for 12 weeks. Sensor glucose, exercise, insulin and meal data will be collected during the DailyDose portion of the study in order to produce recommendations for insulin dosing. Participants will wear the Dexcom G6 for the entire study. Insulin data will be collected using the insulin dose capture system (InPens). Participants will be instructed to use the bolus calculator within the DailyDose app. Participants will be asked to complete a 30-minute aerobic exercise video at home once per week starting with the first 12-week period. After 12 weeks, time in range (70-180 mg/dL, TIR) and time in hypoglycemia (<70 mg/dL) will be assessed from the prior 4 weeks based on the Dexcom G6. Participants that have TIR ≥ 60% and time in hypoglycemia <4% will continue with use of DailyDose. Those that have TIR < 60% and/or time in hypoglycemia ≥ 4% will receive DSMES and, if recommended, behavioral health based on the T1-Diabetes Distress Assessment System (T1-DDAS) for the next 12 weeks. Additionally, if the DSMES provider feels the participant would benefit from behavioral health intervention, they can refer the participant for this even if T1-DDAS scores do not meet the cut off. All participants will then be followed for a final 12-week period using DailyDose alone to assess sustainability of any improvements in glycemic outcomes.

Being tested
DailyDose
Keywords
AB-CDE, DailyDose
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.

  • DailyDoseDevice

    Our team has developed a smartphone-based application, DailyDose Decision Support Tool (DailyDose), that combines continuous glucose monitoring data and insulin data to provide decision support for people living with T1D taking MDI. DailyDose is an iPhone application that is designed to support this population by 1) allowing for bolus calculation based on inputs including carbohydrate intake, CGM value and trend, and exercise information, 2) providing recommendations for carbohydrate intake based on exercise type, intensity, and duration, and 3) providing weekly recommendations for adjustments in insulin doses at specific times of day, including basal insulin dose, carbohydrate ratios or fixed mealtime doses, and correction factors .

Study groups in NCT07282639
Study groupRoleWhat they receive
Intervention GroupExperimentalAB-CDE intervention using DailyDose, study CGM, and CDE and BH counselling if indicated
Receives: Device: DailyDose
Control GroupNo interventionUsual care including MDI insulin therapy with study CGM and DailyDose in Data-logging Mode.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in hemoglobin A1c (HbA1c) from baseline to 24 weeks

    Hemoglobin A1c will be processed by a central lab. Lower values generally indicate better glucose control.

    Measured: Enrollment and 24 weeks after randomization

Secondary outcomes (29)

  1. Change in hemoglobin A1c (HbA1c) from baseline to 36 weeks

    Hemoglobin A1c will be processed by a central lab.

    Measured: Enrollment and 36 weeks

  2. Change in percent of time in range (70-180 mg/dL) from baseline to 24 weeks after randomization

    Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.

    Measured: Week 24 after randomization compared with baseline

  3. Change in percent of time in range (70-180 mg/dL) from baseline to 36 weeks after randomization

    Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.

    Measured: Week 36 after randomization compared with baseline

  4. Change in percent of time in tight range (70-140 mg/dL) from baseline to 24 weeks after randomization

    Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.

    Measured: Week 24 after randomization compared with baseline

  5. Change in percent of time in tight range (70-140 mg/dL) from baseline to 36 weeks after randomization

    Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.

    Measured: Week 36 after randomization compared with baseline

  6. Change in percent of time in low glucose range (<70 mg/dL) from baseline to 24 weeks after randomization

    Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.

    Measured: Week 24 after randomization compared with baseline

  7. Change in percent of time in low glucose range (<70 mg/dL) from baseline to 36 weeks after randomization

    Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.

    Measured: Week 36 after randomization compared with baseline

  8. Change in percent of time in very low glucose range (<54 mg/dL) from baseline to 24 weeks after randomization

    Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.

    Measured: Week 24 after randomization compared with baseline

  9. Change in percent of time in very low glucose range (<54 mg/dL) from baseline to 36 weeks after randomization

    Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.

    Measured: Week 36 after randomization compared with baseline

  10. Change in percent of time in high glucose range (>180 mg/dL) from baseline to 24 weeks after randomization

    Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.

    Measured: Week 24 after randomization compared with baseline

  11. Change in percent of time in high glucose range (>180 mg/dL) from baseline to 36 weeks after randomization

    Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.

    Measured: Week 36 after randomization compared with baseline

  12. Change in percent of time in extreme high glucose range (>250 mg/dL) from baseline to 24 weeks after randomization

    Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.

    Measured: Week 24 after randomization compared with baseline

  13. Change in percent of time in extreme high glucose range (>250 mg/dL) from baseline to 36 weeks after randomization

    Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.

    Measured: Week 36 after randomization compared with baseline

  14. Change in mean blood glucose from baseline to 24 weeks after randomization

    Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. The average of values collected during the two weeks before a study time point will be treated as representing mean glucose at that study time point.

    Measured: Week 24 after randomization compared with baseline

  15. Change in mean blood glucose from baseline to 36 weeks after randomization

    Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. The average of values collected during the two weeks before a study time point will be treated as representing mean glucose at that study time point.

    Measured: Week 36 after randomization compared with baseline

  16. Change in coefficient of variation of blood glucose from baseline to 24 weeks after randomization

    Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. The coefficient of variation (CV) of CGM values is calculated as SD / mean * 100, where SD = standard deviation. The two weeks before a study time point will be used to represent that study time point.

    Measured: Week 24 after randomization compared with baseline

  17. Change in coefficient of variation of blood glucose from baseline to 36 weeks after randomization

    Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. The coefficient of variation (CV) of CGM values is calculated as SD / mean * 100, where SD = standard deviation. The two weeks before a study time point will be used to represent that study time point.

    Measured: Week 36 after randomization compared with baseline

  18. Change in Low Blood Glucose Index (LBGI) from baseline to 24 weeks after randomization

    The Low Blood Glucose Index (LBGI) is designed to reflect the risk of hypoglycemia and increases with the extent and frequency of hypoglycemic excursions. It is calculated by first taking f(BG) = (ln(BG)^1.084 - 5.381) for each blood glucose (BG) reading, then calculating rl(BG) = 22.7 * f(BG)^2 if f(BG) ≤ 0 and rl(BG) = 0 otherwise, and finally, by taking the average of the calculated rl(BG) values over all of the glucose readings measured in mg/dL.

    Measured: Week 24 after randomization compared with baseline

  19. Change in Low Blood Glucose Index (LBGI) from baseline to 36 weeks after randomization

    The Low Blood Glucose Index (LBGI) is designed to reflect the risk of hypoglycemia and increases with the extent and frequency of hypoglycemic excursions. It is calculated by first taking f(BG) = (ln(BG)^1.084 - 5.381) for each blood glucose (BG) reading, then calculating rl(BG) = 22.7 * f(BG)^2 if f(BG) ≤ 0 and rl(BG) = 0 otherwise, and finally, by taking the average of the calculated rl(BG) values over all of the glucose readings measured in mg/dL.

    Measured: Week 36 after randomization compared with baseline

  20. Change in High Blood Glucose Index (HBGI) from baseline to 24 weeks after randomization

    The High Blood Glucose Index (HBGI) is designed to reflect the risk of hyperglycemia and increases with the extent and frequency of hyperglycemic excursions. It is calculated by first taking f(BG) = (ln(BG)^1.084 - 5.381) for each blood glucose (BG) reading, then calculating rh(BG) = 22.7 * f(BG)^2 if f(BG) > 0 and rh(BG) = 0 otherwise, and finally, by taking the average of the calculated rh(BG) values over all of the glucose readings measured in mg/dL.

    Measured: Week 24 after randomization compared with baseline

  21. Change in High Blood Glucose Index (HBGI) from baseline to 36 weeks after randomization

    The High Blood Glucose Index (HBGI) is designed to reflect the risk of hyperglycemia and increases with the extent and frequency of hyperglycemic excursions. It is calculated by first taking f(BG) = (ln(BG)^1.084 - 5.381) for each blood glucose (BG) reading, then calculating rh(BG) = 22.7 * f(BG)^2 if f(BG) > 0 and rh(BG) = 0 otherwise, and finally, by taking the average of the calculated rh(BG) values over all of the glucose readings measured in mg/dL.

    Measured: Week 36 after randomization compared with baseline

  22. Change in T1-DDAS Core Score from baseline to 24 weeks after randomization

    The Type 1 Diabetes Distress Assessment System (T1-DDAS) Core Score is the average of 8 items on a scale from 1 to 5, where 1 is low distress and 5 is high distress associated with having type 1 diabetes.

    Measured: Week 24 after randomization compared with baseline

  23. Change in T1-DDAS Core Score from baseline to 36 weeks after randomization

    The Type 1 Diabetes Distress Assessment System (T1-DDAS) Core Score is the average of 8 items on a scale from 1 to 5, where 1 is low distress and 5 is high distress associated with having type 1 diabetes.

    Measured: Week 36 after randomization compared with baseline

  24. Change in T1-DDAS Management Difficulties Source Score from baseline to 24 weeks after randomization

    The Type 1 Diabetes Distress Assessment System (T1-DDAS) Management Difficulties Source Score is the average of 3 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to management of type 1 diabetes.

    Measured: Week 24 after randomization compared with baseline

  25. Change in T1-DDAS Management Difficulties Source Score from baseline to 36 weeks after randomization

    The Type 1 Diabetes Distress Assessment System (T1-DDAS) Management Difficulties Source Score is the average of 3 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to management of type 1 diabetes.

    Measured: Week 36 after randomization compared with baseline

  26. Change in T1-DDAS Hypoglycemia Concerns Source Score from baseline to 24 weeks after randomization

    The Type 1 Diabetes Distress Assessment System (T1-DDAS) Hypoglycemia Concerns Source Score is the average of 2 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to hypoglycemia.

    Measured: Week 24 after randomization compared with baseline

  27. Change in T1-DDAS Hypoglycemia Concerns Source Score from baseline to 36 weeks after randomization

    The Type 1 Diabetes Distress Assessment System (T1-DDAS) Hypoglycemia Concerns Source Score is the average of 2 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to hypoglycemia.

    Measured: Week 36 after randomization compared with baseline

  28. Change in T1-DDAS Technology Challenges Source Score from baseline to 24 weeks after randomization

    The Type 1 Diabetes Distress Assessment System (T1-DDAS) Technology Challenges Source Score is the average of 3 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to using devices to manage type 1 diabetes.

    Measured: Week 24 after randomization compared with baseline

  29. Change in T1-DDAS Technology Challenges Source Score from baseline to 36 weeks after randomization

    The Type 1 Diabetes Distress Assessment System (T1-DDAS) Technology Challenges Source Score is the average of 3 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to using devices to manage type 1 diabetes.

    Measured: Week 36 after randomization compared with baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2025
  2. Study start8 Jul 2026
  3. Primary completion15 Jul 2027 (estimated)
  4. Study completion15 Dec 2027 (estimated)

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
99 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07282639
Sponsor's protocol ID
25791
Other IDs
2207
Acronym
AB-CDE
Status last verified
Sep 2026
First submitted
5 Dec 2025
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: IPD cannot be shared due to concerns about participant privacy and confidentiality.

Questions about this trial

What is this clinical trial studying?

A study testing DailyDose in people with Type 1 Diabetes (T1D), run by Oregon Health and Science University at 6 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 8 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Linda Lester, MD (503-418-8478, lesterl@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in hemoglobin A1c (HbA1c) from baseline to 24 weeks (time frame: Enrollment and 24 weeks after randomization). 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 NCT07282639.

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 23 Sep 2026.

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