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Insulin Dosing Practices in Persons With Diabetes on Multiple Daily Injections

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ClinicalTrials.gov Identifier: NCT02914730
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Medha Munshi, Joslin Diabetes Center

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.

Condition or disease
Diabetes Medication Adherence Technology Insulin

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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Study Start Date : September 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018



Primary Outcome Measures :
  1. Number of Missed Insulin Doses [ Time Frame: 4 week use of blue tooth pen cap ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914730


Locations
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United States, Massachusetts
Joslin DIabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medha Munshi, Director of Joslin Geriatric Diabetes Programs Beth Israel Deaconess Medical Center Associate Professor of Medicine, Harvard Medical School, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT02914730    
Other Study ID Numbers: CHS #2015-47
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Keywords provided by Medha Munshi, Joslin Diabetes Center:
diabetes
insulin
medication adherence
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases