Clinical trial NCT06089070: Continuous Glucose Monitoring System Feasibility in Youth With T2D
Official title: Feasibility of the FreeStyle Libre Continuous Glucose Monitoring System in Youth With Type 2 Diabetes (FREE CGM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: freestyle libre
continuous glucose monitor
type 2 diabetes
T2D
pediatric
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility study of the FreeStyle Libre Continuous Glucose Monitoring System in Youth with Type 2 Diabetes
Primary purpose: TREATMENT

Brief summary: The primary scientific question of this proposal is to investigate whether youth with T2D will wear and interact with a continuous glucose monitor (CGM) system and whether this will influence behavior and management decisions. There will be 30 participants enrolled in the study. 20 in the treatment arm and 10 in the control. The length of study participation will be 6 months for each participant.

Detailed description: At the beginning of the study, participants will be asked to complete surveys where demographic, clinical and behavioral data will be collected. We will ask participants to wear a glucose sensor that is "blinded" for 14-days so that we can gather baseline data about blood sugar levels.

Participants must wear the CGM sensor for at least 10 days out of the 14 days of the blinding period to move on to the next part of the study. After wearing the blinded sensor, the study team will place participants in one of two groups:

One group (intervention group) will be shown how to use the sensors along with the FreeStyle Libre App, and the other group (control group) will continue with their standard diabetes care without using the CGM system. Participants will be "randomized" into one of the study groups described below. Participants will have a 2 in 3 chance of being placed in the group who receives the glucose sensor and will have access to the data.

Group 1 participants will receive the FreeStyle Libre 3 sensor and have access to the data on their smartphone during the study.

Group 2 participants will be asked to continue standard blood glucose monitoring with a glucometer. Participants will be asked to perform 2 checks a day, fasting and 2 hours post dinner as is standard practice.

If randomized to group 1, participants will receive the FreeStyle Libre 3 system with education from the study coordinator on how to insert sensors and view data on the connected mobile app.

Standardized study education materials with suggestions on how to react to the data such as avoidance of sugary beverages or increased physical activity will also be provided.

Participants will be asked to wear the sensor for the rest of the 6-month participation in the study.

If randomized to group 2, participants will be asked to continue standard blood glucose monitoring with a glucometer. Participants will also receive standardized study education materials about reacting to glucose values. Participants will be asked to perform 2 glucose checks a day, fasting and 2 hours after a meal as is standard practice.

As a part of usual care, participants will come to clinic 3 months after starting the study to meet with their usual diabetes provider and a diabetes educator. We will also have a phone check-in visit with participants at 1 month, 2 months, 4 months, and 5 months after starting the study.

For month 3 and month 6 of the study, participants will already be in clinic to see their regular diabetes provider and we can combine their clinic and research visit. At the end of the study, participants will be invited to come to an optional online focus group to talk about the technology that you used with the study researchers.

Participants will be able to share the things that they liked or did not like about the technology. The researchers will speak with approximately 5-7 participants at a time in a group. The conversation will be recorded via a secure videoconference so that the researchers can remember everything that was said. The audio files will be stored in secure locations and participants' full names will not be used in the sessions.

Additional notes:

* If participants do not have the appropriate device to download the app, a reader will be provided by the study team.
* Diagnoses, medication history, medical history, and lab results will be collected from the medical record for research purposes.
* A Random number generator will be used for randomization.
* The study coordinators and/or the investigators will distribute the participant surveys.
* The study coordinators and the investigators will conduct the focus groups.
* There are no in patient procedures.
* For younger participants who may not be able to complete surveys by themselves, parents or guardians may assist younger participants to complete the surveys.

Parents will be requested to complete the parent reports.

Eligibility criteria: Inclusion Criteria:

1. Age 8- 20 years at the time of consent.
2. Clinical diagnosis of type 2 diabetes.
3. Duration of type 2 diabetes at least 4 weeks.
4. HbA1C ≥ 6.5% .
5. Stable medication regimen (No medication changes and no change in basal insulin dose by more than 20% in the 2 weeks prior to enrollment).
6. No use of CGM 90 days before screening visit.
7. English or Spanish speakers.
8. Willing to abide by recommendations and study procedures.
9. Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF.
10. Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

1. Pancreatic autoantibody positivity (GAD-65, insulin, IA-2, ICA 512, Zn-T8).
2. Plan for undergoing bariatric surgery during the study period.
3. Known history of significant mental illness or developmental delay impacting the ability to complete study activities independently.
4. Known history of adrenal insufficiency, or ongoing renal or hepatic disease.
5. Pregnancy or lactation.
6. Currently undergoing cancer treatment or systemic treatment with steroids.
7. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Primary outcomes:
measure: Ability to use CGM
timeFrame: Measured at 6 months
measure: Acceptability of CGM use measured with Acceptability of Intervention Measure (AIM)
timeFrame: Measured at 6 months
measure: Appropriateness of CGM use measured with Intervention Appropriateness Measure
timeFrame: Measured at 6 months
measure: Feasibility of CGM use measured with Feasibility of Intervention Measure.
timeFrame: Measured at 6 months
Secondary outcomes:
measure: Glycemic change
timeFrame: Baseline (0) to 6 months
measure: Time in target glucose range
timeFrame: Baseline (0) to 6 months
measure: Time above high glucose range
timeFrame: Baseline (0) to 6 months
measure: Time above glucose range
timeFrame: Baseline (0) to 6 months
measure: Time below glucose range
timeFrame: Baseline (0) to 6 months
measure: Time below low glucose range
timeFrame: Baseline (0) to 6 months
measure: Glucose management indicator
timeFrame: Baseline (0) to 6 months
measure: Co-efficient of variation of glucose
timeFrame: Baseline (0) to 6 months
measure: Change in BMI
timeFrame: Baseline (0) to 6 months
measure: Frequency of taking diabetes medications
timeFrame: Baseline (0) to 6 months
measure: Starting or stopping medications
timeFrame: Baseline (0) to 6 months
measure: Titration of insulin dosing by provider
timeFrame: Baseline (0) to 6 months
measure: Dietary measures
timeFrame: Baseline (0) to 6 months
measure: Physical activity measures
timeFrame: Baseline (0) to 6 months
measure: Quality of Life score on survey
timeFrame: Baseline (0) to 6 months
measure: Problem Areas in Diabetes
timeFrame: Baseline (0) to 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco (UCSF)
state: California
Study officials:
affiliation: University of California, San Francisco
name: Shylaja Srinivasan, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: TODAY Study Group; Bjornstad P, Drews KL, Caprio S, Gubitosi-Klug R, Nathan DM, Tesfaldet B, Tryggestad J, White NH, Zeitler P. Long-Term Complications in Youth-Onset Type 2 Diabetes. N Engl J Med. 2021 Jul 29;385(5):416-426. doi: 10.1056/NEJMoa2100165.
citation: TODAY Study Group; Zeitler P, Hirst K, Pyle L, Linder B, Copeland K, Arslanian S, Cuttler L, Nathan DM, Tollefsen S, Wilfley D, Kaufman F. A clinical trial to maintain glycemic control in youth with type 2 diabetes. N Engl J Med. 2012 Jun 14;366(24):2247-56. doi: 10.1056/NEJMoa1109333. Epub 2012 Apr 29.
citation: U.K. prospective diabetes study 16. Overview of 6 years' therapy of type II diabetes: a progressive disease. U.K. Prospective Diabetes Study Group. Diabetes. 1995 Nov;44(11):1249-58.