NCT04428645

Assessment of a Decision Support Tool in Participants With Type 1 Diabetes

Completed NA Results posted Last updated 19 July 2022

What this trial tests

NA trial testing DailyDose Decision Support in Type 1 Diabetes in 25 participants. Completed in 15 November 2021.

Timeline

21 July 2020

Primary endpoint
15 November 2021

15 November 2021

Quick facts

Lead sponsor	Oregon Health and Science University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	21 July 2020
Primary completion	15 November 2021
Estimated completion	15 November 2021
Sites	1 location across United States

Drugs / interventions tested

• DailyDose Decision Support

Conditions studied

• Type 1 Diabetes — all drugs for Type 1 Diabetes →

Sponsor

Oregon Health and Science University

Who can join

Adults 18 to 60, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change in the Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Primary · Weeks 1-2 and 9-10

Mean change in the percent of time with sensed glucose between 70 - 180 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.

Group	Value	95% CI
DailyDose Decision Support	-3.8	± 15.8

Mean Change in Sensed Glucose Secondary · Weeks 1-2 and 9-10

Mean change in sensed glucose based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.

Group	Value	95% CI
DailyDose Decision Support	11	± 28

Mean Change in the Percent of Time With Sensed Glucose <70 mg/dl Secondary · Weeks 1-2 and 9-10

Mean change in the percent of time with sensed glucose \< 70 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.

Group	Value	95% CI
DailyDose Decision Support	-0.3	± 1.0

Mean Change in the Percent of Time With Sensed Glucose <54 mg/dl Secondary · Weeks 1-2 and 9-10

Mean change in the percent of time with sensed glucose \< 54 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.

Group	Value	95% CI
DailyDose Decision Support	0.0006	± 0.472

Mean Change in the Percent of Time With Sensed Glucose >180 mg/dl Secondary · Weeks 1-2 and 9-10

Mean change in the percent of time with sensed glucose \>180 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.

Group	Value	95% CI
DailyDose Decision Support	4.1	± 15.9

Mean Change in the Percent of Time With Sensed Glucose >250 mg/dl Secondary · Weeks 1-2 and 9-10

Mean change in the percent of time with sensed glucose \>250 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.

Group	Value	95% CI
DailyDose Decision Support	5.4	± 12.5

Change in Coefficient of Variation of Sensor Glucose Based on the Dexcom G6 CGM Data. Secondary · Weeks 1-2 and 9-10

Change in coefficient of variation of sensor glucose based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.

Group	Value	95% CI
DailyDose Decision Support	-0.3

Adverse events — posted to ClinicalTrials.gov

Time frame: 10 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

DailyDose Decision Support

Serious: 0/25 (0%)

Deaths: 0/25

Other adverse events (4 terms — click to expand)

Reaction	System	DailyDose Decision Support
upper respiratory infection	Infections and infestations	—
urinary tract infection	Infections and infestations	—
vaginal infection	Infections and infestations	—
strep throat	Infections and infestations	—

Data from ClinicalTrials.gov NCT04428645 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Assessment of a Decision Support System for Adults with Type 1 Diabetes on Multiple Daily Insulin Injections.
   Castle JR, Wilson LM, Tyler NS, Espinoza AZ, et al · · 2022 · cited 18× · PMID 35920839 · DOI 10.1089/dia.2022.0252