Type 1 Diabetes study: DailyDose
Official title App-Based Certified Diabetes Education Therapy (AB-CDE)
ClinicalTrials.gov ID: NCT07282639
What this study is testing
- What it's testing
- This study is testing whether a phone app can help lower blood sugar levels. It checks if the app helps people manage their Type 1 Diabetes better.
- Who it's for
- You may be able to join if you have Type 1 Diabetes.
- What's involved
- You would use a phone app called DailyDose. It tracks your blood sugar, insulin, and exercise to give you tips.
- Time commitment
- The source text does not say how long the study lasts or what visits are needed.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Use of multiple daily insulin injections (MDI) for at least 30 days at the time of screening visit.
You likely can't join if
- Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding or is not using adequate contraceptive methods.
- 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.
- History of diabetes ketoacidosis during the 3 months prior to screening, as diagnosed on hospital admission or as judged by the investigator.
See the full eligibility criteria
- 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
- Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding or is not using adequate contraceptive methods.
- 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.
- History of diabetes ketoacidosis during the 3 months prior to screening, as diagnosed on hospital admission or as judged by the investigator.
- 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).
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Aurora, Colorado, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Aurora, Colorado, United States; Indianapolis, Indiana, United States; Boston, Massachusetts, United States; New York, New York, United States; Portland, Oregon, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.