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

Oregon Health & Science University (OHSU)

Status

Not yet enrolling

Conditions

Type 1 Diabetes (T1D)

Treatments

Device: DailyDose

Study type

Interventional

Funder types

Other

Identifiers

NCT07282639

2207

25791

Details and patient eligibility

About

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.

Full description

Participants will be on study for 38 weeks (2-week run-in period and 36 weeks of intervention/control). 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 Humalog and Basaglar Tempo pens 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 be randomized to the intervention or control group. The intervention group 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 (Tempo pens and Tempo button). 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. Participants in the control group will use the Dexcom G6 CGM, the insulin dose capture system (Tempo pens and Tempo button), and the Data-logging Mode of DailyDose for the entire study. They will also be asked to complete a 30-minute aerobic exercise video at home once per week starting with the first 12-week period.

Enrollment

99 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion 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

Exclusion criteria

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.
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.