NCT02835183

Brief Summary

The investigators propose a randomized cross-over study Phase 1 Clinical trial. 30 type 1 diabetes adult outpatients using insulin pumps and continuous glucose monitoring system will be recruited from the Endocrinology Clinic at the Mayo Clinic Arizona. Participants will be randomly assigned to 4 weeks of using their pump bolus wizards to decide insulin boluses and then 4 wks of using iDECIDE to receive recommendations for insulin dosing, or vice versa. The primary outcomes to compare iDECIDE's insulin dosing algorithm against the pump calculators will be: mean postprandial glucose level and number of events with excessive blood glucose highs and lows.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

9 months

First QC Date

June 6, 2016

Last Update Submit

December 27, 2019

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Compare mean postprandial glucose level

    Compare iDECIDE's insulin dosing algorithm against the pump calculators in terms of mean postprandial glucose level

    2 months

Secondary Outcomes (2)

  • Hypoglycemia events

    2 months

  • Hyperglycemia events

    2 months

Study Arms (2)

Insulin pump followed by iDECIDE

EXPERIMENTAL

Participants will be randomly assigned to 4 weeks of using their insulin pump to decide insulin boluses and then 4 weeks of using iDECIDE to receive recommendations for insulin dosing.

Device: iDECIDEDevice: Insulin pump

iDECIDE followed by insulin pump

EXPERIMENTAL

Participants will be randomly assigned to 4 weeks of using iDECIDE to receive recommendations for insulin dosing and then 4 weeks of using their insulin pump to decide insulin boluses.

Device: iDECIDEDevice: Insulin pump

Interventions

iDECIDEDEVICE

The iDECIDE app will be installed in study participant's smartphone. The app requests from study participants input on food consumed (included food's carbohydrate content), alcohol consumed (included alcohol's carbohydrate content) and exercise plans (including duration and intensity). Based on that input the app suggests insulin bolus dosing.

Insulin pump followed by iDECIDEiDECIDE followed by insulin pump
Insulin pumpDEVICE

Study participants will use during the study their own insulin pump and continuous glucose sensor. As inclusion criteria, investigators expect study participants to have been using their insulin pump and continuous glucose sensor for at least one year.

Insulin pump followed by iDECIDEiDECIDE followed by insulin pump

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Mayo Clinic Arizona type 1 diabetes outpatients,
  • Older than 18 years and younger than 60,
  • Non-pregnant,
  • English speakers,
  • Who use Medtronic insulin pumps and continuous glucose monitoring sensors,
  • Own a smartphone,
  • Have kept in consistent contact with the Mayo Clinic Division of Endocrinology health care team during the last year, and have use the same insulin pump and continuous glucose sensor for at least one year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Infusion Systems

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Drug Delivery SystemsDrug TherapyTherapeuticsInfusion PumpsEquipment and SuppliesArtificial OrgansSurgical Equipment
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 6, 2016

First Posted

July 15, 2016

Study Start

January 1, 2017

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

January 2, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share