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| ID | Type | Description | Link |
|---|---|---|---|
| G-2203-05822 | Other Grant/Funding Number | The Leona M. and Harry B. Helmsley Charitable Trust |
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| Name | Class |
|---|---|
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
| University of Utah | OTHER |
| University of California, Merced | OTHER |
| Children's Hospital Los Angeles |
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The goal of this clinical trial is to evaluate the efficacy of an adapted FAMS (Family/friend Activation to Motivate Self-care) intervention on CGM use among study participants who are CGM users. We will leverage the infrastructure of an NIDDK-funded RCT evaluating FAMS-T1D among N=280 emerging adults with T1D who have elevated hemoglobin A1c or elevated diabetes distress (NCT05820477). We anticipate at least 50% using CGM to be included in these analyses.
FAMS (Family/friend Activation to Motivate Self-care) is a mobile phone-delivered intervention, based on Family Systems Theory, which helps adults with diabetes set behavioral goals and improve support received from friends and family for goal success. FAMS includes monthly phone coaching and text message support by FAMS coaches for the person with diabetes (PWD) and the option to enroll a support person (SP) to receive automated texts tailored to the self-care goals the person with T1D sets in coaching sessions. Adaptations specific to CGM include the option to set CGM use goals in coaching (and receive associated text support) and skill-building exercises during coaching to support data sharing relationships (e.g., establishing, setting and adjusting ground rules about communication).
Within the FAMS-T1D RCT (NCT05820477), we will test effects of FAMS-T1D on CGM use use relative to enhanced treatment as usual. We will evaluate effects on CGM use from baseline to post-intervention (6 months) as the primary endpoint. Study start date for the nested trial (NCT05854069) is the enrollment date of the first participant using a CGM. Since the goal of this trial is to assess effects of the adapted FAMS intervention on CGM use, the date participant CGM usage was confirmed is considered the enrollment date.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAMS-T1D | Experimental | Participants will receive FAMS-T1D components (monthly phone coaching and text message support for goals) for 6 months. Support persons will receive text messages that are tailored to the goal set by the person with type 1 diabetes. All persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to their diabetes. All support persons will also receive materials about type 1 diabetes and how to provide helpful support to the person with diabetes. |
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| Digital resources for diabetes | Placebo Comparator | All persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to their diabetes. All support persons will also receive materials about type 1 diabetes and how to provide helpful support to the person with diabetes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAMS-T1D | Behavioral | FAMS-T1D involves monthly phone coaching that assists individuals in setting specific and time bound diabetes goals with automated text message support to the patient participant and less frequent automated text messages to their support person, if one is enrolled. Behavioral: Diabetes Resources High quality digital materials about diabetes management will be provided upon enrollment and send to participants quarterly. |
| Measure | Description | Time Frame |
|---|---|---|
| CGM frequency of use during the intervention period | Change in CGM frequency of use assessed by self-report on questionnaire; more frequent use/higher is better | Baseline and 6 months post-baseline |
| CGM frequency of use during the intervention period | Change in CGM frequency of use assessed by objective CGM data (% of time; higher is better) | Baseline and 6 months post-baseline |
| Gaps in CGM use | Length of gaps in CGM use as assessed by objective CGM data (measured in number of consecutive days without CGM data; higher is worse) | 6 months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| CGM behavioral responses during the intervention period | Change in frequency of making behavioral changes in response to CGM data assessed by self-report; higher scores indicate more frequent response (better) | Baseline and 6 months post-baseline |
| Barriers to CGM use during the intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Data sharing during the intervention period | Number of data sharing relationships, between groups; more is better | 6 months post-baseline |
| Satisfaction with data-sharing relationships | Satisfaction with data-sharing relationships assessed by CGM-Satisfaction Scale; higher scores are better |
Inclusion Criteria:
PERSONS WITH DIABETES
SUPPORT PERSONS
Exclusion Criteria:
PERSONS WITH DIABETES
SUPPORT PERSONS
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | United States | ||
| University of Utah |
After study results are posted on clinical trials and published, de-identified data will be available upon requests made to the principal investigator.
After study results are posted on clinical trials and outcomes published in a peer-reviewed journal, until 5 years later.
Contact the principal investigator
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
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| Digital resources for diabetes | Behavioral | Quality digital resources about diabetes management provided upon enrollment and during the study. |
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Change in perceived influence of CGM on glycemic control scale assessed by Glucose Monitoring Survey; higher scores indicate more perceived problems with CGM use (worse) |
| Baseline and 6 months post-baseline |
| Barriers to CGM use during the intervention period | Change in perceived influence of CGM on social complications assessed by Glucose Monitoring Survey; higher scores indicate more perceived problems with CGM use (worse) | Baseline and 6 months post-baseline |
| CGM satisfaction during the intervention period | Change in CGM satisfaction assessed by Benefits of CGM scale; higher scores indicate more perceived benefits of CGM use (better) | Baseline and 6 months post-baseline |
| 6 months post-baseline |
| Salt Lake City |
| Utah |
| 84112 |
| United States |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |