App-Based Certified Diabetes Education Therapy (AB-CDE)
ConditionType 1 Diabetes (T1D)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOregon Health and Science University
About this trial
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.
Eligibility criteria
Qualifiers
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]
Disqualifiers
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.
Trial design
Treatments tested in this trial
- DailyDose
Treatment groups
99 Participants
are divided into 2 treatment groupsSponsors and collaborators
Oregon Health and Science University
Lead sponsor
Leona M. & Harry B. Helmsley Charitable Trust
Collaborator
Source ClinicalTrials.gov