A Phase 4 interventional study of Glargine and Lispro in Type 2 Diabetes Mellitus, sponsored by Sandra Sobel. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-12.
Sponsored by Sandra Sobel · Phase 4, Interventional, and Treatment
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 10 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →This is the only study on the registry with Sandra Sobel as lead sponsor.
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Exclusion Criteria:
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.
Drug: Glargine · Drug: Lispro · Device: 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.
Also known as: Lantus
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.
Also known as: Humalog
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.
Also known as: CGM
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.
Time frame: Every 3 months up to 1 year
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.
Time frame: A1C measures every 3 months up to 1 year
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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 4 weeks
Participants were identified using Pitt+Me, an online community which notifies patients about research studies they may be interested.
| Milestone | Insulin and CGM Intervention |
|---|---|
| Started | 10 |
| Completed | 7 |
| Not completed | 3 |
| Withdrew: Lost to follow-up | 3 |
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.
| percentage of glycosylated hemoglobin | Insulin and CGM Intervention |
|---|---|
| Pre-intervention | 9.00 ± 1.56 |
| 3 months | 6.81 ± 0.52 |
| 6 months | 7.13 ± 1.43 |
| 9 months | 7.26 ± 1.41 |
| 12 months | 6.88 ± 1.20 |
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.
| Participants | # of Participants With A1C <6.5% |
|---|---|
| 3 months | 1 |
| 6 months | 2 |
| 9 months | 2 |
| 12 months | 4 |
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
| Participants | # of Participants Who Had a Continuous Glucose Reading <55mg/dL During Insulin Intervention Week |
|---|---|
| Number of Patients With Glucose Values <55 mg/dL During 4 Week of Insulin and CGM Intervention | 4 |
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
| units on a scale | Insulin and CGM Intervention |
|---|---|
| Pre-intervention | 8.90 ± 3.66 |
| Post-intervention | 7.62 ± 4.35 |
Use CGM-captured glucose values to determine how often a participant's glucose levels were in range (percent time in range)
| percentage of time in range | Insulin and CGM Intervention |
|---|---|
| Pre-intervention | 46.3 ± 28.4 |
| Post-intervention | 80.67 ± 10.7 |
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
| Participants | # of Participants Achieving Glucose Targets |
|---|---|
| Fasting Glucose <95 mg/dL | 6 |
| 2hr post prandial glucose <120 mg/dL | 8 |
Collected over 1 year post enrollment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Insulin and CGM Intervention | 0/10 (0%) | 0/10 (0%) | 7/10 (70%) |
| Event | Insulin and CGM Intervention |
|---|---|
| HypoglycemiaEndocrine disorders | 7/10 |
| Signal Loss with Continuous Glucose Monitor (CGM)Endocrine disorders | 6/10 |
| Age, Categorical(Participants) | Insulin and CGM Intervention |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Insulin and CGM Intervention |
|---|---|
| Female | 7 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Insulin and CGM Intervention |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Insulin and CGM Intervention |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Insulin and CGM Intervention |
|---|---|
| United States | 10 |
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