AHCL System Initiation in T1D Patients naïve to Technology

November 4, 2020 updated by: Tomasz Klupa, Jagiellonian University

Transition of Patients With T1D From Multiple Daily Injection (MDI) and Self-Monitoring of Blood Glucose (SMBG) Directly to MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) System :Impact on Glucose Control and Quality of Life Measures

The primary objective of this study is to evaluate whether the MiniMed 780G AHCL system improves glycemic control and Quality of Life (QoL) perception in adult individuals with T1D and naïve to CSII and CGM technologies.

The trial is a two-centers, randomized controlled, parallel group study. Patients will be followed up during approximatively 3 months.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Recent advances in insulin pumps, continuous glucose monitoring (CGM) devices, and control algorithms have resulted in an acceleration of progress in the development of the automated systems of insulin delivery including hybrid closed loop (HCL) systems.

Initial studies on the MiniMed 670G system, the first HCL system approved, have reported increased glycemic control in both adults and pediatrics, having experience with insulin pump therapy with or without experience of CGM technology. More recently it was shown shown even further improvement in glycemic control with the 670G system, in children and adolescents naïve to both pump and CGM technologies. This may be, at least partially, due to lack of willingness of patients to "let the algorithm work" based on their previous experience with CSII and CGM.

The investigators aim to evaluate the impact of an Advanced Hybrid Closed Loop (AHCL) system in adults naïve to pump and CGM technology. For this purpose the investigators target the population of T1DM individuals who are older than 26 years. The study will be conducted in Poland, where only individuals under the age of 26 are entitled to CSII/CGM reimbursement.

If the study succeeds in terms of improved glycemic patterns, quality of life and patients' acceptance, it may provide evidence for consideration in CSII/CGM reimbursement for this population.

Devices usage in the study:

Envision Pro device (CE-marked) will be used to collect CGM data in a retrospective manner. Envision Pro records up to 6 days of data. Patients will wear 2 consecutive Envision Pro devices both during the run-in phase and the at the end of the study phase, i.e. up to 12 days of data. The first Envision Pro device will be placed in the hospital and the second Envision Pro device will be placed by the patient at home, assisted by the study staff on the phone.

In addition, patients from the AHCL group will use the MiniMed 780G AHCL system (CE-marked). The AHCL system will be initiated first in Manual Mode (i.e. without AHCL control) with suspend before low feature. In short, the protocol inputs the current insulin program (MDI) and calculates a 10-20% reduction in total daily dose, with a 40/60 basal/bolus distribution in four or five basal rates. Insulin-to-carbohydrate ratio (ICR) settings utilize the formula of 300-450/total daily dose (TDD) and the formula of 90-110/TDD (mmol/L) with two CF settings; the nighttime CF factor is set 10-20% higher than the daytime CF. Active insulin is set time (3 h); suspend before low feature is turned on with a threshold of 3.0-3.8 mmol/L (55-70 mg/dL), and glucose target ranges from 5.0 to 7.2 mmol/L (90-130 mg/dL.

The AHCL system will be initiated in Auto Mode (i.e. with AHCL control) at Visit 2.At each visit, the AHCL system data will be downloaded and reviewed by the physician. The patient interaction with the system will be evaluated, included sensor calibration, bolus management (before the meals and for corrections as needed), alarms and Auto Mode exits.

At each visit, the glycemic control will be reviewed, and system settings re-assessed and adjusted as needed, including ICR, AIT and basal rates in Manual Mode.

The trial is a two-centers, randomized controlled, parallel group study. Patients will be followed up during approximatively 3 months.

Study phase

Both groups will have a similar number of visits in order to minimize bias. However, the AHCL group will have 2 additional visits to allow for patients to be trained on the AHCL system.

MDI group:

The patient continues MDI treatment as per routine procedures

  • Visit 1 (day 0, can be combined with the randomization visit): BG meter data download, data review and optimization of MDI management.
  • Visit 2 (Visit 1 + 14 days, window +/- 3 days): BG meter data download, data review and optimization of MDI management
  • Visit 3 (Visit 2 + 14 days, window +/- 3 days): BG meter data download, data review and optimization of MDI management
  • Visit 4 (Visit 3 + 28 days, window +/- 7 days): BG meter data download, data review and optimization of MDI management
  • Visit 5 Visit 4 + 22 days, window +/- 7 days): BG meter data download, data review and optimization of MDI management, first professional CGM evaluation start.
  • Visit 6 (Visit 5 + 6 days, window +3 days) - phone call: second professional CGM evaluation start.
  • Visit 7 (Visit 9 + 6 days, window + 3 days): QoL questionnaire, blood sample for HbA1c lab test.

Professional CGM evaluation will be repeated for 6 days in cased less than 10 days data is available.

Study conclusion.

AHCL group:

  • Visit 1 (day 0, can be combined with the randomization visit): the patient will get the pre-reading materials on the 780G system, to be read before Visit 2. CGM training and initiation.
  • Visit 2 (Visit 1 + 1 day, window +7 days): 780G system training and initiation in Manual Mode.
  • Visit 3 (Visit 2 +3 days, window +3 days): 780G system data download. Auto Mode readiness assessment. 780G system initiation in Auto Mode with AHCL control
  • Visit 4 (Visit 3 + 3 days, window +1 day) - phone call: Auto Mode initiation follow-up.
  • Visit 5 (Visit 4 + 7 days, window +/- 3 days): 780G system data download, therapy assessment and optimization
  • Visit 6 (Visit 5 + 14 days, window +/- 3 days): 780G system data download, therapy assessment and optimization
  • Visit 7 (Visit 6 + 28 days, window +/- 7 days): 780G system data download, therapy assessment and optimization
  • Visit 8 (Visit 7 + 22 days, window +/- 7 days): 780G system data download, therapy assessment and optimization, first professional CGM evaluation start.
  • Visit 9 (Visit 8 + 6 days, window +3 days) - phone call: second professional CGM evaluation start.
  • Visit 10 (Visit 9 + 6 days, window + 3 days): 780G system data download, QoL questionnaire, blood sample for HbA1c lab test.

Professional CGM evaluation will be repeated for 6 days in cased less than 10 days data is available.

Study Conclusion

Study endpoints

  • Between group comparison of data measured by CGM technology will be performed based on data collected by professional CGM in both groups.
  • Between group comparison of Quality of Life.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 26 - 60 years at time of screening a clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
  2. Willing to participate in a study for the specified duration
  3. Willing to perform ≥ 4 finger stick blood glucose measurements daily
  4. Willing to perform required sensor calibrations
  5. Willing to wear the system continuously throughout the study
  6. Glycosylated hemoglobin (A1C) value less than 10.0% at time of screening visit
  7. Treated with MDI
  8. Willing to perform at least 4 BGM/day, when on MDI
  9. At least communicative level of English to be able to understand the pump interface.

Exclusion Criteria:

  1. Previous treatment with CSII/CGM
  2. Usage of ultra-rapid insulins, e.g. FIASP
  3. concurrent illness
  4. laboratory abnormalities, or medications that might affect study participation,
  5. current pregnancy
  6. renal impairment
  7. hemoglobin A1c value above 10%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: MDI group:
The patient continues MDI treatment as per routine procedures
Experimental: AHCL group
The patient will use MiniMed 780G AHCL system
Device: insulin pump Medtronic 780G

Patients from the AHCL group will use the MiniMed 780G AHCL system. This system is already CE-marked.

The AHCL system will be initiated first in Manual Mode (i.e. without AHCL control) with suspend before low feature (Visit 1).

The AHCL system will be initiated in Auto Mode (i.e. with AHCL control) at Visit 2 with the settings in the below table. The Insulin to Carb ratio (ICR) and the Active Insulin Time (AIT) may be adjusted by the physician during the study. The glucose target may not be adjusted, unless in case of safety concerns. The patients may not adjust system settings without consulting with the physician.

At each visit, the AHCL system data will be downloaded and reviewed by the physician. The patient interaction with the system will be evaluated, included sensor calibration, bolus management (before the meals and for corrections as needed), alarms and Auto Mode exits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Between group TIR difference
Time Frame: Day 78-90
Between group difference in the percentage of time spent within range with sensor glucose (SG) between 70-180 mg/dL (TIR) (3.9-10.0 mmol/L).
Day 78-90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Between group TIR difference >70%
Time Frame: Day 78-90
Between groups difference in the percentage of participants achieving TIR >70%
Day 78-90
Between group difference in the percentage of time spent:
Time Frame: Day 78-90

• Between group difference in the percentage of time spent:

  • in hyperglycemic range with SG > 250 mg/dL (13.9 mmol/L)
  • in hyperglycemic range with SG > 180 mg/dL (10.0 mmol/L)
  • in hypoglycemic range with SG < 54 mg/dL (3.0 mmol/L)
  • in hypoglycemic range with SG < 70 mg/dL (3.9 mmol/L)
Day 78-90
Between group difference in the mean glucose level
Time Frame: Day 78-90
Between group difference in the mean glucose level
Day 78-90
Between group difference in the glycemic variability measure by SD and CV
Time Frame: Day 78-90
Between group difference in the glycemic variability measure by SD and CV
Day 78-90
Between group difference in the HbA1c levels
Time Frame: Day 78-90
Between group difference in the HbA1c levels
Day 78-90
Between group difference in the Diabetes Quality of Life (QoL) questionnaire score
Time Frame: Day 90
Between group difference in the Diabetes Quality of Life (QoL) questionnaire score
Day 90

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of severe hypoglycemic episodes
Time Frame: Day 90
"Severe Hypoglycemia" is an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. (American Diabetes Association Workgroup on Hypoglycemia, Diabetes Care 28:1245-1249, 2005)
Day 90
Number of Diabetic Ketoacidosis events
Time Frame: Day 90
"Diabetic Ketoacidosis/DKA" is defined as: Hyperglycemia (blood glucose >250 mg/dL or >13.9 mmol/L) with either low serum bicarbonate (<15 mEq/L) and/or low pH (<7.24) Anion gap (> 12) and either ketonemia or ketonuria and requiring treatment within a health-care facility. (American Diabetes Association-Diabetes Care, Volume 27, Supplement 1, January 2004).
Day 90
Number of Severe Hyperglycemia episodes
Time Frame: Day 90
"Severe Hyperglycemia" is defined as Hyperglycemia (blood glucose >270 mg/dL) with blood glucose ketones >0.6mmol/L or accompanied by symptoms of nausea, vomiting or abdominal pain.
Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Collaborators

Medtronic Poland Spółka z ograniczoną odpowiedzialnością
University of Rzeszow

Investigators

  • Principal Investigator: Tomasz Klupa, Prof, Hospital University; Jagiellonian University Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 2, 2020

Primary Completion (Anticipated)

March 31, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (Actual)

November 5, 2020

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1072.61201.8.2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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