Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Evaluation of Minimed 670G Hybrid Closed Loop System On-Boarding Protocol, for Patients With Type 1 Diabetes on Multiple Daily Insulin Injection Therapy
NCT number | NCT03755479 |
Other study ID # | 1810033883 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2019 |
Est. completion date | August 11, 2019 |
Verified date | September 2019 |
Source | Sidra Medical and Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | August 11, 2019 |
Est. primary completion date | August 8, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 17 Years |
Eligibility |
Inclusion Criteria: 1. 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. 2. HbA1c < 12.5% 3. Age 6-17 years at the initiation of the 670G system 4. Multiple Daily Injections (Basal Bolus therapy) with Total Daily Insulin use of great than 8.0 units per day over a 1 week period 5. Willing and able (access to internet from home) to download information into the Medtronic CareLink software 6. Clinically planning to and be able to start the Medtronic 670G HCL system 7. History of 3 clinic visits in the last year Exclusion Criteria: 1. DKA in the 6 months prior to screening visit |
Country | Name | City | State |
---|---|---|---|
Qatar | Sidra Medicine | Doha | Qa |
Lead Sponsor | Collaborator |
---|---|
Sidra Medical and Research Center |
Qatar,
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. — View Citation
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. — View Citation
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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. — View Citation
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. — View Citation
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. — View Citation
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. Epub 2016 Sep 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in HbA1c | Change in HbA1c levels from previous treatment (multiple daily injections) compared to Minimed 670G treatment | 3 months | |
Secondary | Glucose values above Range (>180 mg/dl) | Percentage of glucose values more than 180 mg/dl on Minimed 670G | 3 months | |
Secondary | Time spend in Auto Mode | Percentage of time in Auto Mode, where Minimed 670G automatic adjusts the basal insulin dose according glucose levels | 3 months |
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