CGM to Aid Transition From Inpatient to Outpatient

NCT03155594 | Unknown FDA Device

• 1 other identifier: 1023056-2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

A pilot study using the FreeStyle Libre to assess its potential benefits in patients with diabetes starting when they are inpatients and continuing during the transition of care to the outpatient setting to see if diabetes care can be improved after discharge. This study is designed to address the following questions:

1. 1.How do the glucose readings from FreeStyle Libre Pro compare to our inpatient glucometer system? Is the system is accurate enough to use for clinical decision making?
2. 2.How often does the additional continuous glucose data change inpatient care?
3. 3.Does this technology work with inpatient nursing workflow?
4. 4.Does leaving the patch on at discharge and reading in the office improve transition of care?
5. 5.Does reading the patch after discharge in the office improve follow-up care?

Conditions

Diabete Mellitus

Keywords

Diabetes; Diabetes Mellitus; Diabetes Type 1; Diabetes Type 2; CGM; Continuous Glucose Monitoring; Inpatient; Outpatient; Transition of care; DM-1; DM-2; Freestyle Libre

Outcome Measures

Primary Outcomes (1)

• Changes in care

  Each day a clinician from the Diabetes Service sees a patient in the hospital or office setting after discharge, they will download the information in the sensor patch. The clinician will note on the data collection sheet if the additional information changed the care compared to the information available from the hospital and patient glucose testing.

  2 weeks

Secondary Outcomes (1)

• Accuracy of device

  2 weeks

Study Arms (1)

Single arm

EXPERIMENTAL

Patients in this trial will receive a FreeStyle Libre patch that continuously measures glucose in addition to their standard glucose monitoring.

Device: Freestyle Libre

Interventions

Freestyle Libre DEVICE

Continuous glucose monitoring patch

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatients on insulin therapy 18 years and older on insulin with glucose testing 4-5 times per day
• Patient able to sign informed consent.

You may not qualify if:

• Patient unable to give informed consent
• Critically ill patients will not be started in the CGM patch, but he patch will not be removed if transferred to ICU.
• Patients currently on acetaminophen
• Currently on diathermy treatments
• Pregnancy
• Dialysis
• Currently on vitamin C
• Patient is sensitive to the adhesive or develops significant skin irritation.
• Treatment for dehydration

Sponsors & Collaborators

• Methodist Medical Center of Illinois: lead

Study Sites (1)

Methodist Medica Center of Illinois

Peoria, Illinois, 61602, United States

Location

Related Publications (9)

• Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.

  PMID: 28118453 BACKGROUND

• Bailey KJ, Little JP, Jung ME. Self-Monitoring Using Continuous Glucose Monitors with Real-Time Feedback Improves Exercise Adherence in Individuals with Impaired Blood Glucose: A Pilot Study. Diabetes Technol Ther. 2016 Mar;18(3):185-93. doi: 10.1089/dia.2015.0285. Epub 2016 Feb 17.

  PMID: 26885934 BACKGROUND

• Sato J, Kanazawa A, Ikeda F, Shigihara N, Kawaguchi M, Komiya K, Uchida T, Ogihara T, Mita T, Shimizu T, Fujitani Y, Watada H. Effect of treatment guidance using a retrospective continuous glucose monitoring system on glycaemic control in outpatients with type 2 diabetes mellitus: A randomized controlled trial. J Int Med Res. 2016 Feb;44(1):109-21. doi: 10.1177/0300060515600190. Epub 2015 Dec 7.

  PMID: 26647072 BACKGROUND

• De Block CE, Gios J, Verheyen N, Manuel-y-Keenoy B, Rogiers P, Jorens PG, Scuffi C, Van Gaal LF. Randomized Evaluation of Glycemic Control in the Medical Intensive Care Unit Using Real-Time Continuous Glucose Monitoring (REGIMEN Trial). Diabetes Technol Ther. 2015 Dec;17(12):889-98. doi: 10.1089/dia.2015.0151. Epub 2015 Aug 25.

  PMID: 26305390 BACKGROUND

• Schaupp L, Donsa K, Neubauer KM, Mader JK, Aberer F, Holl B, Spat S, Augustin T, Beck P, Pieber TR, Plank J. Taking a Closer Look--Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients with Type 2 Diabetes Mellitus Under Basal-Bolus Insulin Therapy. Diabetes Technol Ther. 2015 Sep;17(9):611-8. doi: 10.1089/dia.2014.0343. Epub 2015 Apr 30.

  PMID: 25927357 BACKGROUND

• Kusunoki Y, Katsuno T, Nakae R, Watanabe K, Akagami T, Ochi F, Tokuda M, Murai K, Miuchi M, Miyagawa J, Namba M. Evaluation of blood glucose fluctuation in Japanese patients with type 1 diabetes mellitus by self-monitoring of blood glucose and continuous glucose monitoring. Diabetes Res Clin Pract. 2015 May;108(2):342-9. doi: 10.1016/j.diabres.2015.01.040. Epub 2015 Mar 4.

  PMID: 25779865 BACKGROUND

• Joubert M, Fourmy C, Henri P, Ficheux M, Lobbedez T, Reznik Y. Effectiveness of continuous glucose monitoring in dialysis patients with diabetes: the DIALYDIAB pilot study. Diabetes Res Clin Pract. 2015 Mar;107(3):348-54. doi: 10.1016/j.diabres.2015.01.026. Epub 2015 Jan 21.

  PMID: 25638452 BACKGROUND

• Kepenekian L, Smagala A, Meyer L, Imhoff O, Alenabi F, Serb L, Fleury D, Dorey F, Krummel T, Le Floch JP, Chantrel F, Kessler L. Continuous glucose monitoring in hemodialyzed patients with type 2 diabetes: a multicenter pilot study. Clin Nephrol. 2014 Oct;82(4):240-6. doi: 10.5414/CN108280.

  PMID: 25161114 BACKGROUND

• Boom DT, Sechterberger MK, Rijkenberg S, Kreder S, Bosman RJ, Wester JP, van Stijn I, DeVries JH, van der Voort PH. Insulin treatment guided by subcutaneous continuous glucose monitoring compared to frequent point-of-care measurement in critically ill patients: a randomized controlled trial. Crit Care. 2014 Aug 20;18(4):453. doi: 10.1186/s13054-014-0453-9.

  PMID: 25139609 BACKGROUND

Related Links

• Device website

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• David E. Trachtenbarg, MD

  Methodist Medical Center of Illinois

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: APN

Model Details: Adult patients in the hospital receiving 4-5 glucometer checks per day

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 16, 2017
• Study Start: May 9, 2017
• Primary Completion: July 15, 2017
• Study Completion: August 1, 2017
• Last Updated: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)