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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.
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:
Parents will be requested to complete the parent reports.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Participants will not have access to view the data from the CGM sensor during the screening period, nor during the main part of the study. | |
| Intervention | Experimental | Participants will wear the CGM sensor and have access to the data during the main part of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeStyle Libre Continuous Glucose Monitor System | Device | Continuous Glucose Monitor System for people with Type 2 Diabetes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ability to use CGM | Use of CGM measured by number of hours participants in the intervention arm wear the CGM device and view data on the mobile application. | Measured at 6 months |
| Acceptability of CGM use measured with Acceptability of Intervention Measure (AIM) | The perception that CGM use is agreeable or satisfactory measured with the 4-item Acceptability of Intervention Measure (AIM). Greater the score, higher the acceptability | Measured at 6 months |
| Appropriateness of CGM use measured with Intervention Appropriateness Measure | The perceived fit of the CGM to improve diabetes related metrics measured with the 4-item Intervention Appropriateness Measure (IAM). Greater the score, higher the appropriateness of CGM use | Measured at 6 months |
| Feasibility of CGM use measured with Feasibility of Intervention Measure. | The extent to which a CGM study can be successfully carried out measured with 4-item Feasibility of Intervention Measure (FIM). The higher the score, the greater the feasibility of CGM use | Measured at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic change | Change in HbA1C at 6 months adjusted for the baseline value youth with T2D. | Baseline (0) to 6 months |
| Time in target glucose range | Time spent in target glucose range of 70 to 180 mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shylaja Srinivasan, MD, MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco (UCSF) | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36868256 | Result | Wagenknecht LE, Lawrence JM, Isom S, Jensen ET, Dabelea D, Liese AD, Dolan LM, Shah AS, Bellatorre A, Sauder K, Marcovina S, Reynolds K, Pihoker C, Imperatore G, Divers J; SEARCH for Diabetes in Youth study. Trends in incidence of youth-onset type 1 and type 2 diabetes in the USA, 2002-18: results from the population-based SEARCH for Diabetes in Youth study. Lancet Diabetes Endocrinol. 2023 Apr;11(4):242-250. doi: 10.1016/S2213-8587(23)00025-6. Epub 2023 Feb 28. | |
| 34320286 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Feasibility study of the FreeStyle Libre Continuous Glucose Monitoring System in Youth with Type 2 Diabetes
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N/A both study team and participants will know the randomization assignment as to which group they are in.
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| Baseline (0) to 6 months |
| Time above high glucose range | percent of readings and time >250 mg/dL | Baseline (0) to 6 months |
| Time above glucose range | percent of readings and time 181-250 mg/dL | Baseline (0) to 6 months |
| Time below glucose range | percent of readings and time 54-69 mg/dL | Baseline (0) to 6 months |
| Time below low glucose range | percent of readings and time <54 mg/dl | Baseline (0) to 6 months |
| Glucose management indicator | CGM metric that indicates average blood glucose | Baseline (0) to 6 months |
| Co-efficient of variation of glucose | CGM metric that measures variability in CGM values | Baseline (0) to 6 months |
| Change in BMI | Change in BMI SDS over the course of the study | Baseline (0) to 6 months |
| Frequency of taking diabetes medications | Self-reported medication adherence in the past week before visit | Baseline (0) to 6 months |
| Starting or stopping medications | Percentage of subjects with addition or removal of diabetes medications | Baseline (0) to 6 months |
| Titration of insulin dosing by provider | Percentage of subjects who receive insulin dose titration | Baseline (0) to 6 months |
| Dietary measures | Change in score on SEARCH for Diabetes in Youth food frequency questionnaire. This is a 85 question survey ( Mayer-Davis EJ, Nichols M, Liese AD et al. (2006) Dietary intake among youth with diabetes: the SEARCH for Diabetes in Youth Study. J Am Diet Assoc.2006) | Baseline (0) to 6 months |
| Physical activity measures | Number of minutes of physical activity in the past week before visit. The greater the value the better the score. | Baseline (0) to 6 months |
| Quality of Life score on survey | Pediatric Quality of Life Inventory Diabetes Module score. 33 item score. The greater the value the better the score. | Baseline (0) to 6 months |
| Problem Areas in Diabetes | Problem Areas In Diabetes (PAID) Scale. 20 question survey. Higher the score, the worse the outcome | Baseline (0) to 6 months |
| Result |
| 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. |
| 22540912 | Result | 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. |
| 7589820 | Result | 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. |
| D004700 | Endocrine System Diseases |