A Study of Technology to Improve Glucose Control in Participants With Type 1 Diabetes

Technology-supported, Meal-centric, Insulin Dosing for Optimized Post-prandial Glucose Control

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03758430

Enrollment

Registered

2018-11-29

Start date

2019-02-06

Completion date

2020-08-07

Last updated

2020-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Brief summary

The main purpose of this study is to determine whether combining meal, glucose, and insulin data in a web-based system will improve management of type 1 diabetes (T1D). No study drug will be given. The study will last about 18 weeks.

Interventions

OTHERMeal-Tagging App

Meal tagging app to capture frequently eaten meals and test meals for 16 weeks.

DEVICEFitness Tracker

Fitness tracker will be worn around the clock for 16 weeks.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* T1D by clinical diagnosis for \> 3 years * Insulin pump use \> 3 months: must use one of the following pump types: Animas Ping and Vibe, Insulet Omnipod, Medtronic 523/723 and 530G, Tandem t:slim and t:flex * Continuous Glucose Monitor (CGM) \> 3 months and current use of Dexcom G5 at least 6 out of 7 days per week * HbA1c 7.0-9.5% * Must have iPhone (meal-tagging app has been built on iOS) * Personal computer for uploading of pump and CGM devices * Willingness to follow study protocol including tagging food data * Comfort speaking, reading, and writing English

Exclusion criteria

* Individuals currently using a hybrid closed-loop system (e.g., Medtronic 670G) * Individuals planning to follow a specific diet plan for weight loss * Inability to consume common meals * Gastroparesis; * Eating disorder * Evidence of missed insulin meal-time insulin boluses on pump download * Use of medications that can affect blood glucose levels (such as SGLT inhibitors, steroid, beta agonists) * Use of medications that affect gastric emptying (such as GLP agonists, pramlinitide) * Alcohol abuse * Pre-conception, pregnancy, or lactation

Design outcomes

Primary

Measure	Time frame	Description
Change from Baseline to Week 16 in Hemoglobin A1c (HbA1c)	Baseline to Week 16	Change from Baseline to Week 16 in HbA1c

Secondary

Measure	Time frame	Description
Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals	Baseline to Week 16	Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026