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

NCT04428645 | Completed Results FDA Device

• 1 other identifier: 19950
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Mean Change in the Percent of Time With Sensed Glucose Between 70 - 180 mg/dl

  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.

  Weeks 1-2 and 9-10

Secondary Outcomes (6)

• Mean Change in Sensed Glucose

  Weeks 1-2 and 9-10

• Mean Change in the Percent of Time With Sensed Glucose <70 mg/dl

  Weeks 1-2 and 9-10

• Mean Change in the Percent of Time With Sensed Glucose <54 mg/dl

  Weeks 1-2 and 9-10

• Mean Change in the Percent of Time With Sensed Glucose >180 mg/dl

  Weeks 1-2 and 9-10

• Mean Change in the Percent of Time With Sensed Glucose >250 mg/dl

  Weeks 1-2 and 9-10

Study Arms (1)

DailyDose Decision Support

EXPERIMENTAL

Subjects will use DailyDose decision support for 8 weeks at home.

Device: DailyDose Decision Support

Interventions

DailyDose Decision Support DEVICE

DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.

DailyDose Decision Support

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Castle JR, Wilson LM, Tyler NS, Espinoza AZ, Mosquera-Lopez CM, Kushner T, Young GM, Pinsonault J, Dodier RH, Hilts WW, Oganessian SM, Branigan DL, Gabo VB, Eom JH, Ramsey K, Youssef JE, Cafazzo JA, Winters-Stone K, Jacobs PG. Assessment of a Decision Support System for Adults with Type 1 Diabetes on Multiple Daily Insulin Injections. Diabetes Technol Ther. 2022 Dec;24(12):892-897. doi: 10.1089/dia.2022.0252. Epub 2022 Sep 5.

  PMID: 35920839 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Jessica Castle
• Organization: Oregon Health and Science University

castleje@ohsu.edu

503-494-7072

Study Officials

• Peter Jacobs, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Jessica Castle, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: July 21, 2020
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: July 19, 2022
• Results First Posted: May 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)