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REMIT-DM is a feasibility pilot study where participants will be recruited soon after their diagnosis of type 2 diabetes to be placed immediately on insulin therapy for maximum of four weeks with titrations of insulin guided by glucose levels and trends provided by a continuous glucose monitor (CGM), with the purpose of achieving diabetes remission.
REMIT-DM is a feasibility pilot study that aims to show that previously published diabetes remission through early use and titration of short-term insulin therapy is possible and safe in the ambulatory diverse American population of patients with T2D, with continuous glucose level and trend information provided by CGM. We developed the algorithm based on published diabetes remission studies and include within the algorithm the CGM trend arrows to further refine insulin doses for both safety and efficacy purposes. Data captured by the CGM transmits automatically to the cloud and is accessible at any time of day by the multidisciplinary diabetes team, which includes the certified diabetes educator (CDE) and Endocrinologist. The CGM-guided insulin titration algorithm is designed to achieve euglycemia (defined as fasting CBG < 100 mg/dL, and 2 hour post-prandial CBG < 120 mg/dL) within 2 weeks of initiating insulin therapy, then to help maintain euglycemia for 2 weeks before discontinuing insulin entirely. Ten participants will undergo a maximum of 4 weeks of insulin therapy and will be assessed for remission afterwards to confirm enough recovery of beta cell function. (Complete remission is defined as fasting glycemia <100 mg/dL without use of pharmacological therapy.) Afterwards, we will implement American Diabetes Association (ADA) guidelines for standard glycemic management, as necessary. We will use the data collected during this feasibility study to sharpen the CGM-guided insulin titration algorithm for creation of a T2DM remission mobile application that could then be tested and studied in a larger sample size.
The feasibility study will also take into account clinically meaningful data points e.g. the number of phone calls between the patient and the diabetes team, the patient experience, and patient satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin and CGM Intervention | Experimental | 10 individuals with newly diagnosed type 2 diabetes will be started on basal (glargine) bolus (lispro) insulin therapy for up to 4 weeks with titrations guided by continuous glucose monitor (Dexcom G6) to achieve euglycemia and then insulin stopped after 4 weeks with hopes of diabetes remission. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glargine | Drug | Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Baseline A1C and A1C Measured at 3 Month Intervals up to 12 Months | Blood test drawn at baseline and after insulin and CGM-guided titration intervention at 3 month intervals to see if improvement in aggregate A1C value is achieved. | Every 3 months up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With A1C of <6.5% After CGM-guided Insulin Therapy Intervention | See if A1C achieves threshold <6.5% with intensive daily titration of basal bolus insulin therapy, guided by the individual's continuous glucose monitoring value and trend arrow - all guided by our algorithm. | A1C measures every 3 months up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra I Sobel, MD | University of Pittsburgh | Principal Investigator |
| David A Rometo, MD | University of Pittsburgh | Principal Investigator |
| Linda Siminerio, RN PhD | University of Pittsburgh | Principal Investigator |
| Shari Reynolds | University of Pittsburgh | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Falk Diabetes Clinic | Pittsburgh | Pennsylvania | 15213 | United States |
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Participants were identified using Pitt+Me, an online community which notifies patients about research studies they may be interested.
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin and CGM Intervention | 10 individuals with newly diagnosed type 2 diabetes will be started on basal (glargine) bolus (lispro) insulin therapy for up to 4 weeks with titrations guided by continuous glucose monitor (Dexcom G6) to achieve euglycemia and then insulin stopped after 4 weeks with hopes of diabetes remission. Glargine: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved. Lispro: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved. Dexcom G6: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin and CGM Intervention | 10 individuals with newly diagnosed type 2 diabetes will be started on basal (glargine) bolus (lispro) insulin therapy for up to 4 weeks with titrations guided by continuous glucose monitor (Dexcom G6) to achieve euglycemia and then insulin stopped after 4 weeks with hopes of diabetes remission. Glargine: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved. Lispro: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved. Dexcom G6: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Baseline A1C and A1C Measured at 3 Month Intervals up to 12 Months | Blood test drawn at baseline and after insulin and CGM-guided titration intervention at 3 month intervals to see if improvement in aggregate A1C value is achieved. | Individuals recruited had newly diagnosed type 2 diabetes, never on insulin therapy. They may have been on other anti-hyperglycemic agents. The reason why the number analyzed in one or more rows differs from the overall number analyzed is because two of the patients unfortunately did not get baseline A1C measurements. and starting at month 6, 3 participants were lost to follow up | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Every 3 months up to 1 year |
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1 year post enrollment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insulin and CGM Intervention | 10 individuals with newly diagnosed type 2 diabetes will be started on basal (glargine) bolus (lispro) insulin therapy for up to 4 weeks with titrations guided by continuous glucose monitor (Dexcom G6) to achieve euglycemia and then insulin stopped after 4 weeks with hopes of diabetes remission. Glargine: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved. Lispro: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved. Dexcom G6: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Endocrine disorders | Non-systematic Assessment | This is defined as events of continuous glucose monitor or self-monitored blood glucose measure <70mg/dL that did not result in neuroglycopenia or require the assistance of others to resolve and was transient. |
Statistical analyses beyond those reported here were not conducted due to low number of participants enrolled
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Rometo, MD | University of Pittsburgh Medical Center (UPMC) | 412-586-9700 | rometoda@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2021 | Jul 9, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 6, 2021 | Jul 9, 2021 | ICF_001.pdf |
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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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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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10 participants will be recruited soon after diagnosis of type 2 diabetes and started on short term insulin therapy to achieve euglycemia with insulin doses guided by continuous glucose monitor algorithm
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| Lispro | Drug | Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved. |
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| Dexcom G6 | Device | Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved. |
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| Number of Patients With Glucose Values <55 mg/dL During 4 Week of Insulin and CGM Intervention |
We wanted to ensure that during the course of the intensive CGM-guided insulin therapy, our algorithm would be able to avoid severe hypoglycemia, defined as a glucose reading of <55mg/dL in the study participants |
| 4 weeks |
| See if Diabetes Distress is Affected With Intervention Via Problem Areas In Diabetes (PAID) - 5 Questionnaire Scale | Administer the PAID-5 scale, which is a measure of diabetes distress. The scale ranges from a minimum of 0 (not a problem) to a maximum score of 4 (serious problem). The sum of the five questions provides the participant's score with a score range of minimum score of 0 to a maximum score of 20. A total score of greater than or equal to 8 indicates possible diabetes related emotional distress, with a higher score indicating more significant distress. This will be given to participants to see if/how distress levels change via the intervention | 1 year |
| Percent Time Glucose Values Remain in Range While Wearing CGM During Insulin Intervention | Use CGM-captured glucose values to determine how often a participant's glucose levels were in range (percent time in range) | 4 weeks |
| Number of Participants Achieving Euglycemic Glucose Targets Within a 4 Week Period | The design of the algorithm was to attempt to achieve glucose values in the normal glycemic range, as defined as fasting BG target 80-95 mg/dL, and 2 hour post prandial BG target 100-120 mg/dL, within 2 weeks of starting insulin and maintaining values until end of 4 week intervention. We wanted to see if our CGM-guided insulin algorithm could help participants achieve pre-defined euglycemic glucose targets in four week period | 4 weeks |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Number of Participants With A1C of <6.5% After CGM-guided Insulin Therapy Intervention | See if A1C achieves threshold <6.5% with intensive daily titration of basal bolus insulin therapy, guided by the individual's continuous glucose monitoring value and trend arrow - all guided by our algorithm. | These were the same 10 participants that were recruited at the beginning of the study, individuals with type 2 diabetes never on insulin therapy. We had one lost to follow up at 3 months and then 3 lost to follow-up at the remaining 3 month marks until completion of the study 1 year later | Posted | Count of Participants | Participants | A1C measures every 3 months up to 1 year |
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| Secondary | Number of Patients With Glucose Values <55 mg/dL During 4 Week of Insulin and CGM Intervention | We wanted to ensure that during the course of the intensive CGM-guided insulin therapy, our algorithm would be able to avoid severe hypoglycemia, defined as a glucose reading of <55mg/dL in the study participants | All participants with newly diagnosed type 2 diabetes were placed on CGM monitoring and had individualized insulin therapy for 4 weeks, with the goal of achieving predetermined glycemic targets. We wanted to see if any of the participants experienced severe hypoglycemia during this insulin intervention phase. | Posted | Count of Participants | Participants | 4 weeks |
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| Secondary | See if Diabetes Distress is Affected With Intervention Via Problem Areas In Diabetes (PAID) - 5 Questionnaire Scale | Administer the PAID-5 scale, which is a measure of diabetes distress. The scale ranges from a minimum of 0 (not a problem) to a maximum score of 4 (serious problem). The sum of the five questions provides the participant's score with a score range of minimum score of 0 to a maximum score of 20. A total score of greater than or equal to 8 indicates possible diabetes related emotional distress, with a higher score indicating more significant distress. This will be given to participants to see if/how distress levels change via the intervention | Posted | Mean | Standard Deviation | units on a scale | 1 year |
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| Secondary | Percent Time Glucose Values Remain in Range While Wearing CGM During Insulin Intervention | Use CGM-captured glucose values to determine how often a participant's glucose levels were in range (percent time in range) | Posted | Mean | Standard Deviation | percentage of time in range | 4 weeks |
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| Secondary | Number of Participants Achieving Euglycemic Glucose Targets Within a 4 Week Period | The design of the algorithm was to attempt to achieve glucose values in the normal glycemic range, as defined as fasting BG target 80-95 mg/dL, and 2 hour post prandial BG target 100-120 mg/dL, within 2 weeks of starting insulin and maintaining values until end of 4 week intervention. We wanted to see if our CGM-guided insulin algorithm could help participants achieve pre-defined euglycemic glucose targets in four week period | The 10 participants analyzed were the same 10 participants recruited at the beginning of the study with newly diagnosed diabetes, never before on insulin therapy, using our CGM-guided insulin algorithm to try to achieve euglycemia within 4 weeks of therapy | Posted | Count of Participants | Participants | 4 weeks |
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| 0 |
| 10 |
| 0 |
| 10 |
| 7 |
| 10 |
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| Signal Loss with Continuous Glucose Monitor (CGM) | Endocrine disorders | Non-systematic Assessment | This captures the number of participants who had signal loss with their CGM from greater than 4 hours |
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| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |
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| 9 months |
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| 12 months |
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