App-Based Certified Diabetes Education Therapy (AB-CDE)
Development and Evaluation of App-Based Certified Diabetes Education (AB-CDE) Therapy for People Living With T1D Using MDI
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 38 weeks, 12 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will be on study for 38 weeks (2-week run-in period and 36 weeks of intervention)."
- "Participants will then use the DailyDose system for 12 weeks."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether DailyDose, a smartphone app, can lower average blood sugar measured by an A1c test. The app uses blood sugar, insulin, and exercise data to suggest insulin doses and carb intake during exercise or low blood sugar. It is for adults with type 1 diabetes who take several insulin shots each day.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have had type 1 diabetes for at least 1 year and be age 18 or older.
- Be able to read, write, and understand spoken English.
- Have an A1c or GMI of 7.5%–11.5%. These measure or estimate average blood sugar.
- For GMI, have 30 days of blood sugar sensor data, with the sensor active at least 70% of the time.
- Have used several daily insulin shots for at least 30 days and need less than 200 units a day.
- Be willing to use Humalog and Basaglar Tempo insulin pens and a Dexcom G6 blood sugar sensor.
- Be willing to use the study iPhone and Apple Watch.
- Be able to follow study steps on your own and attend all clinic, diabetes education, and behavioral health visits.
Who can't join
- Be pregnant, planning pregnancy, or breastfeeding; or be able to become pregnant without using an accepted birth control method.
- Have a history of stroke, certain heart problems or heart procedures; poor kidney or liver function; or adrenal glands that make too little hormone.
- Have had severe low blood sugar or diabetic ketoacidosis (dangerous acid buildup) in the past 3 months, or have trouble noticing low blood sugar.
- Have had a mental health hospital stay in the past 6 months; suspected alcohol or drug abuse; uncontrolled seizures; an active infection; a foot sore; or severe poor blood flow in the legs.
- Have a bleeding disorder, take warfarin, have very low platelets (blood cells that help stop bleeding), or have an allergy to Humalog or Basaglar. Long-term immune-suppressing drugs or steroid pills or shots also rule you out.
- Have had major surgery or used an experimental drug in the past 30 days; started or changed a non-insulin diabetes drug in the past 6 weeks; or be in another diabetes or obesity treatment study.
- Have a life-threatening illness, cancer within the past 5 years except certain skin cancers, slow stomach emptying, or another condition the study doctor thinks makes joining unsafe. Eating less than 50 grams of carbs daily also rules you out.
- Have chest discomfort with activity or certain answers on the exercise safety survey. Taking just one blood pressure drug does not rule you out if blood pressure is below 140/90.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Diagnosis of type 1 diabetes mellitus for at least 1 year. 2. Age 18 years and older. 3. Able to read, write and understand spoken English 4. 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\[6\] 5. Use of multiple daily insulin injections (MDI) for at least 30 days at the time of screening visit. 6. Willing to use the approved study insulin and devices while on study - Humalog and Basaglar Tempo pens, Dexcom G6 CGM, study iPhone, Apple watch 7. Willingness and ability to independently follow all study procedures, including attending all clinic and DSMES and behavioral health visits. 8. Total daily insulin requirements of less than 200 units Exclusion Criteria: 1. 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. 2. History of stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. 3. Renal insufficiency (GFR \< 60 ml/min, using either MDRD\*\* or CKD-EPI# equation as reported by the laboratory). 4. Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator. 5. 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. 6. History of diabetes ketoacidosis during the 3 months prior to screening, as diagnosed on hospital admission or as judged by the investigator. 7. History of psychiatric admission during the 6 months prior to screening. 8. Adrenal insufficiency. 9. Any active infection. 10. Known or suspected abuse of alcohol, narcotics, or illicit drugs. 11. Uncontrolled seizure disorder. 12. Active foot ulceration. 13. Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication. 14. Major surgical operation within 30 days prior to screening. 15. Use of an investigational drug within 30 days prior to screening. 16. Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus). 17. Bleeding disorder, treatment with warfarin, or platelet count below 50,000. 18. Allergy to Humalog or Basaglar insulin. 19. Current chronic administration of oral or parenteral corticosteroids. 20. 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). 21. 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). 22. Any chest discomfort with physical activity, including pain or pressure, or other types of discomfort. 23. Gastroparesis. 24. On a very low carbohydrate diet (less than 50g per day) 25. Taking part in another diabetes or obesity-related treatment study. 26. Any clinically significant disease or disorder which, in the opinion of the Investigator, may jeopardize the participant's safety or compliance with the protocol.
Study sites (6)
CA
- University of Southern California · Los Angeles, CA 90022Anna Peters, MD · Study contact · 323-362-1320 · annepete@med.usc.eduValerie Ruelas · Study contact · vruelas@usc.eduMore trials in Los Angeles
CO
- Barbara Davis Center · Aurora, CO 80045Halis Akturk, MD · Study contact · 303-724-0467 · halis.akturk@cuanschutz.eduEmma Mason · Study contact · 303-724-5895 · emma.mason@cuanschutz.eduMore trials in Aurora
IN
- Indiana University · Indianapolis, IN 46202Viral Shah, MD · Study contact · 317-274-7605 · shahvi@iu.eduBrittany Thorne · Study contact · 317-278-0532 · thorneb@iu.eduMore trials in Indianapolis
MA
- Joslin Diabetes Center, Harvard School of Medicine · Boston, MA 02215Joslin Toschi, MD · Study contact · 617-309-2440 · Elena.Toschi@joslin.harvard.eduChristine Slyne · Study contact · Christine.slyne@joslin.harvard.eduMore trials in Boston
NY
- Mount Sinai School of Medicine · New York, NY 10029Carol Levy, MD · Study contact · 212-241-0068 · carol.levy@mssm.eduSarah Rancic · Study contact · sarah.rancic@mssm.eduCamilla Levister · Sub-investigatorMore trials in New York
OR
- Oregon Health & Science University , Portland · Portland, OR 97239Linda Lester, MD · Study contact · 503-418-8478 · lesterl@ohsu.eduPeter Jacobs, PhD · Principal investigatorMore trials in Portland