Fuzzy Logic Automated Insulin Regulation



Status:Not yet recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:14 - 30
Updated:3/13/2019
Start Date:May 13, 2019
End Date:June 29, 2020
Contact:Richard Bergenstal, MD
Email:richard.bergenstal@parknicollet.com
Phone:952-993-1913

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A Crossover Study Comparing Two Automated Insulin Delivery System Algorithms (PID vs. PID + Fuzzy Logic) in Adolescents and Young Adults With Type 1 Diabetes

Adolescents and young adults with type 1 diabetes often have a difficult time achieving good
glucose control which is so important in reducing the risk for diabetes complications.
Despite the use of multiple daily injections or insulin pumps and glucose sensors there is
still a need for many individuals to further improve glucose levels but do so without causing
low blood glucose levels (hypoglycemia) or adding to the daily burden of living with
diabetes. Today an insulin pump can receive glucose readings from a continuous glucose
monitor and adjust the insulin delivery up or down in an attempt to keep glucose levels in a
more optimal range. These systems are called hybrid closed loop meaning while much of the
insulin delivery is automated the patient still interacts regularly with the system
particularly to help determine the insulin dose to deliver to cover a meal. Results of early
studies using hybrid closed loop systems in adolescents and adults with type 1 diabetes are
very encouraging. This study will compare the FDA-approved hybrid closed loop system by
Medtronic (670G) to a next-generation Medtronic system programmed to further improve glucose
control, particularly around mealtime, which is currently one of the biggest challenges with
all hybrid closed loop systems. One hundred adolescents and young adults (ages 14-30) will
test each system for three months in a crossover fashion. The investigators will compare how
effective each hybrid closed loop system is at preventing high blood glucose readings during
day. The investigators will also evaluate the safety of each system and how participants
adjust to the daily use of the technology.

Seven clinical sites (4 in the US and 3 in Europe) will enroll patients with type 1 diabetes
(T1D), ages 14 to less than 30 years old, who have an HbA1c from 7-12% and are using multiple
daily injections of insulin (with or without continuous glucose monitoring -CGM) or are using
and insulin pump (with or without CGM). Participants may not be currently using the Medtronic
670G system. All patients will be assessed for their QOL and attitudes about the use diabetes
management technology.

- Patients glucose control on their current insulin treatment regimen will be assessed for
2 weeks using blinded CGM (CGM they cannot see the glucose reading on).

- Then all participants will be started on the same insulin pump (Medtronic 670G) and the
pump standard insulin delivery settings will be adjusted.

- Next all participants will start an Enlite 3 continuous glucose sensor and be instructed
on its use and further adjustments to the insulin pump settings will be made using this
CGM information. The pump remains in the usual manual mode or open loop mode of
operation at this time.

- All patients will then be randomized to start hybrid closed loop therapy using one of
two systems for 12 weeks. They will either use the 670G pump (which uses an algorithm
called PID to adjust insulin delivery based on the Enlite 3 CGM data) in open loop or
auto mode for 3 months or they will use a different Medtronic Pump very similar in
nature the 670G but this has a slightly different algorithm called PID + Fuzzy Logic) to
adjust insulin delivery based on the Enlite 3 CGM data in open loop or auto mode for 3
months. Glucose control, adjustment to the technology and the safety of the technology
will all be carefully evaluated over this 3 month period with the participants at home,
school or work undergoing their usual activities. They will have regular contact with
the study team and will intermittently share their ongoing CGM glucose data with the
study team at a clinic visit or by uploading their glucose and insulin data to the cloud
so it can viewed in a secure fashion by the study team.

- At the end of 3 months each participant will go back on the 670 G and the CGM system in
manual mode or open loop for one month. This is called the washout period.

- Then all participants will switch to or crossover to the hybrid closed system they were
not on originally and use this new hybrid closed loop system in closed loop or auto mode
for 3 months as above.

- At the end of each 3 month period on either the 670G system using the PID algorithm or
the new hybrid closed loop system using the PID + Fuzzy Logic algorithm participants
will rate their QOL and their adjustment to and attitude toward the hybrid closed loop
system they are using.

- A careful analysis of the all measures of glucose control based on the CGM data for each
3 month period for each hybrid closed loop system will be collected and compared. In
addition system safety data will be collected as will all medical events during the
study.

After each participant has completed 3 months on each hybrid closed loop system the
investigators will be able to compare the effectiveness, safety and patient preference
regarding each system.

Inclusion Criteria:

1. Type 1 diabetes mellitus with duration of at least one year.

2. Multiple daily injections of insulin or an insulin pump user

3. HbA1c 7.0%-12.0%

4. Willingness or ability to do carbohydrate counting

5. In the investigator's judgment, able to understand and likely to be adherent to the
protocol

6. For subjects <18 years old, living with one or more parent/legal guardian 7. Have
internet access and a computer system that meets requirements for uploading data

Exclusion Criteria:

1. Concomitant disease that influence metabolic control (e.g. anemia, significantly
impaired hepatic function, renal failure, history of adrenal insufficiency)

2. Other medical condition which, in the Investigator's opinion, may compromise patient
safety, affect outcome assessments, or affect the subject's ability to follow the
protocol.

3. Oral or parenteral glucocorticoids taken within 1 month prior to enrollment, or plans
to take oral or parenteral glucocorticoids within the planned study duration.

4. Use of antidiabetic agents other than insulin

5. Use of other medications, which in the judgment of the investigator would be a
contraindication to participation in the study

6. Known allergy to medical grade adhesives

7. Participation in another study of a medical device or drug that could affect glucose
measurements or glucose management or receipt of any investigational medical product
within 1 month prior to enrollment

8. Female subject of child-bearing potential who has a positive pregnancy test at
screening, is pregnant, breast-feeding, or planning to become pregnant within the
planned study duration (or is not using adequate contraceptive methods)

9. Current eating disorder such as anorexia or bulimia

10. One or more episodes of ketoacidosis requiring hospitalization within 6 months prior
to screening

11. Clinically significant nephropathy (eGFR <30 ml/min) or receiving dialysis

12. Untreated thyroid disease

13. Working a night shift
We found this trial at
5
sites
New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Desmond Schatz, MD
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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One Joslin Place
Boston, Massachusetts 02215
617-309-2400
Principal Investigator: Lori Laffel, MD
Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
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Boston, MA
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Hannover, 28403
Principal Investigator: Thomas Danne, MD
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Hannover,
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3800 Park Nicollet Boulevard
Saint Louis Park, Minnesota 55416
Principal Investigator: Amy Criego, MD
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Saint Louis Park, MN
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