N/A
N=25
Assessment of a Decision Support Tool in Participants With Type 1 Diabetes
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04428645 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Mean Change in the Percent of Time With Sensed Glucose Between 70 - 180 mg/dl — -3.8 percentage of time
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DailyDose Decision Support (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in the Percent of Time With Sensed Glucose Between 70 - 180 mg/dl |
-3.8 | — |
| SECONDARY Mean Change in Sensed Glucose |
11 | — |
| SECONDARY Mean Change in the Percent of Time With Sensed Glucose <70 mg/dl |
-0.3 | — |
| SECONDARY Mean Change in the Percent of Time With Sensed Glucose <54 mg/dl |
0.0006 | — |
| SECONDARY Mean Change in the Percent of Time With Sensed Glucose >180 mg/dl |
4.1 | — |
| SECONDARY Mean Change in the Percent of Time With Sensed Glucose >250 mg/dl |
5.4 | — |
| SECONDARY Change in Coefficient of Variation of Sensor Glucose Based on the Dexcom G6 CGM Data. |
-0.3 | — |
Summary
Type 1 diabetes (T1D) is a complex disease with a high risk of both hyper- and hypoglycemia which can lead to severe acute and chronic complications. The burden and complexity of managing T1D results in the majority of people not reaching adequate glycemic control. Our team has developed a smartphone based application, DailyDose, that combines continuous glucose monitoring data and insulin data to provide decision support for subjects with type 1 diabetes taking multiple daily injections (MDI). DailyDose provides on-demand, real-time dosing recommendations for insulin doses prior to meals and to correct hyperglycemia. DailyDose analyzes glucose patterns and provides weekly recommendations to the patient on insulin settings including carbohydrate ratios and correction factors. As needed, DailyDose will make weekly recommendations to change basal insulin. For subject safety, study investigators will set constraints on settings for short and long acting insulin during the onboarding process. DailyDose will not be able to recommend insulin dose changes above or below the set safety thresholds. DailyDose also provides recommendations on carbohydrate intake for exercise and includes hypoglycemia and hyperglycemia alarms.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of type 1 diabetes mellitus for at least 1 year.
- Male or female subjects 18 to 60 years of age.
- Physically willing and able to perform 30 min of exercise (as determined by the investigator after reviewing the subject's activity level).
- Use of multiple daily insulin injections (MDI) for at least 4 weeks at time of screening visit.
- A1C 7.0-10.0% at the time of screening.
- Willingness to follow all study procedures, including attending all clinic visits.
- Willingness to sign informed consent and HIPAA documents.
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.
- Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.
- Renal insufficiency (GFR < 60 ml/min, using the MDRD equation as reported by the OHSU laboratory).
- Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.
- History of severe hypoglycemia during the past 6 months prior to screening visit or hypoglycemia unawareness as judged by the investigator. Subjects will complete a hypoglycemia awareness questionnaire. Subjects will be excluded for four or more R responses.
- Any active infection.
- Known or suspected abuse of alcohol, narcotics, or illicit drugs.
- Seizure disorder.
- Active foot ulceration.
- Peripheral arterial disease.
- 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).
- Allergy to aspart insulin.
- Current administration of oral or parenteral corticosteroids.
- Any life threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer).
- Current use of any medication intended to lower glucose other than insulin (ex. use of liraglutide).
- Vision impairment which in the opinion of the investigator would preclude the use of the smart phone application.
- A positive response to any of the questions from the Physical Activity Readiness Questionnaire with one exception: subject will not be excluded if he/she takes a single blood pressure medication that doesn't impact heart rate and blood pressure is controlled on the medication (blood pressure is less than 140/90 mmHg).
Data sourced from ClinicalTrials.gov (NCT04428645). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.