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Behavioural Intervention

AI-Based Snack Intervention for Type 1 Diabetes

N/A

Recruiting

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Using multiple daily injections

Diagnosis of type 1 diabetes mellitus for at least 1 year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks (4-week control period vs. 4-week intervention period)

Awards & highlights

Study Summary

This trial studies if an AI-based snack intervention can reduce nocturnal low glucose levels in people with type 1 diabetes.

Who is the study for?

Adults with Type 1 Diabetes using multiple daily insulin injections, not pregnant or breastfeeding, and practicing effective contraception can join. They must have had diabetes for at least a year, an HbA1c level below 10%, and recent overnight low blood sugar episodes. Those with severe hypoglycemia history need a trained companion nearby.Check my eligibility

What is being tested?

The study tests an AI-based smart snack app against standard continuous glucose monitoring (CGM) therapy to prevent nighttime low blood sugar in Type 1 Diabetics on multiple daily injections. It's a crossover trial where participants will try both methods.See study design

What are the potential side effects?

Since the interventions involve technology use rather than medication, typical drug side effects are not expected. However, there may be risks associated with incorrect glucose level readings or technical issues with the app or CGM device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I use multiple daily injections for my condition.

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I have been diagnosed with type 1 diabetes for over a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks (4-week control period vs. 4-week intervention period)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks (4-week control period vs. 4-week intervention period)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks (4-week control period vs. 4-week intervention period) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Probability of overnight hypoglycemia

Secondary outcome measures

Accuracy of overnight low glucose prediction by sensitivity

Accuracy of overnight low glucose prediction by specificity

Change in weight

+13 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Participants will use the DailyDose Smart Snack smart phone application which contains an AI-based model that predicts the likelihood of overnight low glucose at bedtime every night and will recommend a personalized snack to help avoid nocturnal hypoglycemia. The nutritional content of the snack (carbohydrate, protein, fat, etc.) will be dependent on the predicted overnight minimum glucose and the predicted time of the minimum overnight glucose level. During this arm, participants will also be asked to wear a smart watch overnight, weigh themselves weekly, and answer a one-item sleep quality scale survey weekly.

Group II: ControlActive Control1 Intervention

Participants will wear Dexcom G6 CGM and will manage their glucose as usual. Participants will be asked to wear a smart watch overnight to collect sleep metrics, weigh themselves weekly in the morning before eating, and answer a one-item sleep quality scale survey weekly.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

974 Previous Clinical Trials

7,385,892 Total Patients Enrolled

14 Trials studying Diabetes Mellitus

1,954,565 Patients Enrolled for Diabetes Mellitus

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does my profile meet the criteria to enroll in this experiment?

"This clinical study requires that applicants must suffer from diabetes mellitus, are between 18 and 100 years old, and is currently looking for approximately 20 participants."

Answered by AI

How many individuals can participate in this clinical investigation?

"Affirmative. Data sourced from clinicaltrials.gov reveals that this scientific research, first posted on September 1st 2023 is actively seeking participants. Approximately 20 people need to be enrolled at a single site."

Answered by AI

Is this clinical research currently engaging participants?

"Affirmative. Clinicaltrials.gov details an ongoing recruitment effort which was initially published on September 1st 2023 and has since been updated in some capacity. The study is seeking to enroll a total of 20 participants at one medical centre."

Answered by AI

Does the research team consider applicants aged 20 and above?

"The age range for inclusion in this trial is 18 to 100. Meanwhile, there are 159 separate trials catered towards minors and 209 specifically aimed at seniors."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DailyDose Smart Snack Study for T1D on MDI

2023. "DailyDose Smart Snack Study for T1D on MDI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05967260.

All > Hypoglycemia