Insulin Dosing Practices in Persons With Diabetes on Mult... | NCT02914730

Studies
Insulin Dosing Practices in Persons With Diabetes on Multiple Daily Injections

NCT02914730

Sponsor

Joslin Diabetes Center

Status

Completed

Last Update Posted

Aug 14, 2018Actual

Enrollment

75Actual

Phase

Not provided

Conditions

Diabetes
Medication Adherence
Technology
Insulin

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Jul 2018Actual

Completion Date

Jul 2018Actual

First Submitted Date

Sep 22, 2016

First Submission Date that Met QC Criteria

Sep 22, 2016

First Posted Date

Sep 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2018

Last Update Posted Date

Aug 14, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Medha Munshi, Director of Joslin Geriatric Diabetes Programs Beth Israel Deaconess Medical Center Associate Professor of Medicine, Harvard Medical School, Joslin Diabetes CenterPrincipal Investigator

Lead Sponsor

Joslin Diabetes CenterOTHER

Collaborators

Not provided

Description Module

Brief Summary

In this cross-sectional study the investigators will examine two populations: young adults with (ages 18-35) and older adults (ages 65 and over) with diabetes who are on > 2 insulin injections per day. The sample size for this observational study will be up to 125 patients. The investigators will issue a Common Sensing GoCap bluetooth-enabled pen cap that fits on the end of Solostar Lantus and Apidra insulin pens; this pen cap registers the position of the insulin pen plunger and automatically sends confirmation of dose delivery to a smartphone app.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Missed Insulin Doses		4 week use of blue tooth pen cap

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 1 diabetes or insulin-requiring Type 2 diabetes
> 2 insulin injections
Age 18-35 or older than 65 years
Use of glargine insulin as basal insulin
Stable insulin doses for past 3 months

Exclusion Criteria:

Previous tape/adhesive allergies with CGM sensors
Visual or cognitive impairment with inability to self-administer insulin

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Joslin DIabetes Center		Boston	Massachusetts	02215	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30862650	Derived	Munshi MN, Slyne C, Greenberg JM, Greaves T, Lee A, Carl S, Atakov-Castillo A, Toschi E. Nonadherence to Insulin Therapy Detected by Bluetooth-Enabled Pen Cap Is Associated With Poor Glycemic Control. Diabetes Care. 2019 Jun;42(6):1129-1131. doi: 10.2337/dc18-1631. Epub 2019 Mar 12.

ID	Term
D003920	Diabetes Mellitus
D055118	Medication Adherence
D007333	Insulin Resistance

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases