NCT03755479

Brief Summary

Introduction. Sensor Augmented Pump has demonstrated superiority over insulin pump and Multiple Daily Injection (MDI) in achieving optimal glucose control and can improve quality of life in Type 1 Diabetes (T1D) patients. Hybrid closed loop (HCL) insulin pump Minimed 670G is a FDA approved device and European Conformity (CE) mark with SmartGuard technology and closed loop algorithm, which will allow the patients to improve their diabetes management. Hybrid closed loop insulin pump Minimed 670G monitors glucose in the subcutaneous tissues and automatically adjusts the delivery of rapid acting insulin as basal rate based on the user's glucose reading. SmartGuard technology in insulin pump, based on user's sensor glucose values can predict when glucose is approaching low levels, 30 minutes in advance and automatically stop insulin delivery. When user's glucose levels recover, SmartGuard will automatically resume insulin delivery. CareLink is personal software, which downloads the data from insulin pump, glucose sensor and glucometer to visualize diabetes information with charts, statistics and events that help patient and health provider to identify and understand patterns and trends The objective of this study is to assess structured group education on boarding protocol of the HCL Minimed 670 G in achieving glucose control of patients on MDI. Methods. This study is a single-arm, single-center, clinical investigation in subjects with type 1 diabetes on HCL insulin pump (Minimed 670G) in a period of 3 months. A total of 30 subjects (age 6 - 17) will be enrolled in order to reach 26 subjects who will complete the HCL study. The investigators will start the clinical process for initiating an insulin pump, which is typically done with pre-pump classes. HbA1c, derived from CGM will be performed at baseline and 3 months during the study. The following parameters will be analyzed: % patients achieving Time in Range (TIR) \> 67% from 70 mg/dl to 180 mg/dl; % patients achieving TIR \<3%, below time in range (\<70 mg/dl) and % patients achieving both TIR \> 67% and \<3% time below Range. Collection of demographics and medical history, data for diabetes devices (eg meters, sensors, pumps) and brief clinical physical exam including vital signs and skin assessment will be obtained via Hospital Electronic Medical File (Cerner Millennium, North Kansas City, US) and will be kept as electronic data on a separate research server.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 25, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

November 25, 2018

Last Update Submit

September 4, 2019

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus Type 1Insulin PumpHybrid closed Loop SystemMinimed 670G

Outcome Measures

Primary Outcomes (1)

  • Achieving glucose values more than 67% in Time in Range (70-180 mg/dl)

    Primary outcome is to achieve glucose levels more than 67% in range between 70mg and 180 mg/dl using Minimed 670G

    3 months

Secondary Outcomes (3)

  • Change in HbA1c

    3 months

  • Glucose values above Range (>180 mg/dl)

    3 months

  • Time spend in Auto Mode

    3 months

Study Arms (1)

Single Arm Group

Patient on multiple daily injections will start Hybrid Closed Loop System Insulin Pump Minimed 670G

Device: Hybrid Closed Loop Insulin Pump Minimed 670G

Interventions

Hybrid Closed Loop Insulin Pump Minimed 670GDEVICE

Five Day Group Education on Minimed 670G

Single Arm Group

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients with Type 1 Diabetes on Multiple Daily Injections, motivated and willing to switch Hybrid Closed Loop Minimed 670G.

You may qualify if:

  • Clinical diagnosis of Type 1 Diabetes. Diagnosis of Type 1 Diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
  • HbA1c \< 12.5%
  • Age 6-17 years at the initiation of the 670G system
  • Multiple Daily Injections (Basal Bolus therapy) with Total Daily Insulin use of great than 8.0 units per day over a 1 week period
  • Willing and able (access to internet from home) to download information into the Medtronic CareLink software
  • Clinically planning to and be able to start the Medtronic 670G HCL system
  • History of 3 clinic visits in the last year

You may not qualify if:

  • \. DKA in the 6 months prior to screening visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sidra Medicine

Doha, Qa, 26999, Qatar

Location

Related Publications (8)

  • Ly TT, Roy A, Grosman B, Shin J, Campbell A, Monirabbasi S, Liang B, von Eyben R, Shanmugham S, Clinton P, Buckingham BA. Day and Night Closed-Loop Control Using the Integrated Medtronic Hybrid Closed-Loop System in Type 1 Diabetes at Diabetes Camp. Diabetes Care. 2015 Jul;38(7):1205-11. doi: 10.2337/dc14-3073. Epub 2015 Jun 6.

    PMID: 26049550BACKGROUND

  • Ly TT, Weinzimer SA, Maahs DM, Sherr JL, Roy A, Grosman B, Cantwell M, Kurtz N, Carria L, Messer L, von Eyben R, Buckingham BA. Automated hybrid closed-loop control with a proportional-integral-derivative based system in adolescents and adults with type 1 diabetes: individualizing settings for optimal performance. Pediatr Diabetes. 2017 Aug;18(5):348-355. doi: 10.1111/pedi.12399. Epub 2016 May 18.

    PMID: 27191182BACKGROUND

  • de Bock MI, Roy A, Cooper MN, Dart JA, Berthold CL, Retterath AJ, Freeman KE, Grosman B, Kurtz N, Kaufman F, Jones TW, Davis EA. Feasibility of Outpatient 24-Hour Closed-Loop Insulin Delivery. Diabetes Care. 2015 Nov;38(11):e186-7. doi: 10.2337/dc15-1047. Epub 2015 Aug 27. No abstract available.

    PMID: 26316630BACKGROUND

  • Bergenstal RM, Garg S, Weinzimer SA, Buckingham BA, Bode BW, Tamborlane WV, Kaufman FR. Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes. JAMA. 2016 Oct 4;316(13):1407-1408. doi: 10.1001/jama.2016.11708. No abstract available.

    PMID: 27629148BACKGROUND

  • Ruiz JL, Sherr JL, Cengiz E, Carria L, Roy A, Voskanyan G, Tamborlane WV, Weinzimer SA. Effect of insulin feedback on closed-loop glucose control: a crossover study. J Diabetes Sci Technol. 2012 Sep 1;6(5):1123-30. doi: 10.1177/193229681200600517.

    PMID: 23063039BACKGROUND

  • de Bock M, Dart J, Roy A, Davey R, Soon W, Berthold C, Retterath A, Grosman B, Kurtz N, Davis E, Jones T. Exploration of the Performance of a Hybrid Closed Loop Insulin Delivery Algorithm That Includes Insulin Delivery Limits Designed to Protect Against Hypoglycemia. J Diabetes Sci Technol. 2017 Jan;11(1):68-73. doi: 10.1177/1932296816668876. Epub 2016 Sep 25.

    PMID: 27621143BACKGROUND

  • Bailey TS, Ahmann A, Brazg R, Christiansen M, Garg S, Watkins E, Welsh JB, Lee SW. Accuracy and acceptability of the 6-day Enlite continuous subcutaneous glucose sensor. Diabetes Technol Ther. 2014 May;16(5):277-83. doi: 10.1089/dia.2013.0222. Epub 2014 Apr 7.

    PMID: 24758729BACKGROUND

  • Tauschmann M, Allen JM, Wilinska ME, Thabit H, Acerini CL, Dunger DB, Hovorka R. Home Use of Day-and-Night Hybrid Closed-Loop Insulin Delivery in Suboptimally Controlled Adolescents With Type 1 Diabetes: A 3-Week, Free-Living, Randomized Crossover Trial. Diabetes Care. 2016 Nov;39(11):2019-2025. doi: 10.2337/dc16-1094. Epub 2016 Sep 9.

    PMID: 27612500BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

  • Goran Petrovski, MD, PhD

    Sidra Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Goran Petrovski, MD PhD

Study Record Dates

First Submitted

November 25, 2018

First Posted

November 28, 2018

Study Start

February 1, 2019

Primary Completion

August 8, 2019

Study Completion

August 11, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

QA(1)