LOAN2DOSE and COIN2DOSE for Type 1 Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Type 1 Diabetes Mellitus+1 More
LOAN2DOSE and COIN2DOSE - Behavioral
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether these programs can improve blood sugar control for adolescents with T1D.

Eligible Conditions
  • Type 1 Diabetes Mellitus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Type 1 Diabetes Mellitus

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: baseline, 90 and 180 days

baseline and 180 days
Change in A1C (ΔA1C180-day) from baseline visit (visit 1) to 180-day visit (visit 3).
baseline and 90 days
Change in A1C (ΔA1C90-day) from baseline visit (visit 1) to 90-day visit (visit 2)
Day 180
Change in health-related empowerment from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).
Change in mealtime insulin BOLUS score (BOLUS) from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).
Change in perceived involvement in care from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).
Change in percent Time hypoglycemic (<70 mg/dL; %Hypo<70) from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).
Change in percent Time severely hypoglycemic (<54 mg/dL) (%Hypo<54) from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).
Change in percent time hyperglycemic (>180 mg/dL; %Hyper>180) from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).
Change in percent time in range 70-180 mg/dL (%TIR70-180) from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).
Change in trust in provider from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).
For COIN2DOSE treatment group, >75% of participants will have a score of at least 14 out of a total possible 18 points on Diabetes Treatment Satisfaction Questionnaire (teen version).
Interventional procedure
For LOAN2DOSE treatment group, proportion of participants wearing the apple watch throughout the 90-day intervention period >75% of days.
For LOAN2DOSE treatment group, proportion of participants who complete >90% of study procedures throughout the intervention and post-intervention study procedures.
For LOAN2DOSE treatment group, proportion of participants who deliver insulin bolus doses within 10 minutes of >75% of mealtime bolus reminders.

Trial Safety

Safety Progress

1 of 3

Other trials for Type 1 Diabetes Mellitus

Trial Design

3 Treatment Groups

Control
1 of 3
COIN2DOSE
1 of 3
LOAN2DOSE
1 of 3
Active Control
Experimental Treatment

36 Total Participants · 3 Treatment Groups

Primary Treatment: LOAN2DOSE and COIN2DOSE · No Placebo Group · N/A

COIN2DOSE
Behavioral
Experimental Group · 1 Intervention: LOAN2DOSE and COIN2DOSE · Intervention Types: Behavioral
LOAN2DOSE
Behavioral
Experimental Group · 1 Intervention: LOAN2DOSE and COIN2DOSE · Intervention Types: Behavioral
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 90 and 180 days

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor
226 Previous Clinical Trials
1,269,975 Total Patients Enrolled
8 Trials studying Type 1 Diabetes Mellitus
1,140 Patients Enrolled for Type 1 Diabetes Mellitus

Eligibility Criteria

Age < 65 · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The youth must be predicted to have a rise in A1C in of 0.3% or higher the next 90 days.
I am not pregnant and I am not planning to become pregnant.
The participant has an iPhone or iPad that is compatible with Klue.
The youth must be using an insulin delivery device that can record, store, and download insulin bolus behaviors (insulin pump or smart Bluetooth insulin pen that can be uploaded to standard clinic upload software).
You have attended at least 2 T1D standard of care visits in the past 12 months.
Children aged 12-17.
The youth must have had diabetes for at least six months.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: October 31st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Missouri100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Children's Mercy Kansas City100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%