App-Based Certified Diabetes Education Therapy (AB-CDE)
ConditionType 1 Diabetes (T1D)
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
DailyDose
DeviceOur 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 .
Treatment groups
99 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
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.
Time frame
Enrollment and 24 weeks after randomizationSecondary outcomes
1
Change in hemoglobin A1c (HbA1c) from baseline to 36 weeks
Hemoglobin A1c will be processed by a central lab.
Time frame
Enrollment and 36 weeks2
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.
Time frame
Week 24 after randomization compared with baseline3
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.
Time frame
Week 36 after randomization compared with baseline4
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.
Time frame
Week 24 after randomization compared with baselineOther outcomes
1
Change in mean number of low glucose events / week from baseline to 24 weeks after randomization
A single low glucose event is defined to start when the CGM drops below 70 mg/dL for at least three measurements and ends when the CGM rises above 69 mg/dL for at least three measurements. The two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Time frame
Week 24 after randomization compared with baseline2
Change in mean number of low glucose events / week from baseline to 36 weeks after randomization
A single low glucose event is defined to start when the CGM drops below 70 mg/dL for at least three measurements and ends when the CGM rises above 69 mg/dL for at least three measurements. The two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Time frame
Week 36 after randomization compared with baseline3
Change in total daily dose of insulin (units) from baseline to 24 weeks
Insulin use will be tracked using bluetooth-enabled insulin pens. The two weeks before a study time point will be treated as representing that study time point.
Time frame
Week 24 after randomization compared with baseline4
Change in total daily dose of insulin (units) from baseline to 36 weeks
Insulin use will be tracked using bluetooth-enabled insulin pens. The two weeks before a study time point will be treated as representing that study time point.
Time frame
Week 36 after randomization compared with baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oregon Health and Science University
Lead sponsor
Leona M. & Harry B. Helmsley Charitable Trust
Collaborator
Source ClinicalTrials.gov