Type 2 Diabetes Mellitus
Conditions
Keywords
Insulin therapy, Continuous glucose monitor
Brief summary
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.
Detailed description
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.
Interventions
DRUGGlargine
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.
DRUGLispro
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.
DEVICEDexcom 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.
Sponsors
Sandra Sobel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 2. A1C criteria - \>7.0 3. Newly diagnosed with T2D within 4 years 4. Lifestyle controlled 5. Subject may be on up to 2 medications for diabetes. 6. Smart phone or home computer compatible with DEXCOM CLARITY software 7. English speaking 8. Assessed by endocrinologist and diabetes educator to be able to perform skills necessary for CGM use and insulin delivery
Exclusion criteria
1. Autoimmune Type 1 DM, defined as positive GAD65 or islet cell antibodies 2. Pregnant 3. Chronic Kidney Disease (CKD) Stage IV or greater 4. Mental and/or cognitive disorder (based on documented disorder and/or assessment of physician or educator) 5. No access to computer for downloading CGM 6. BMI \<18.0
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Baseline A1C and A1C Measured at 3 Month Intervals up to 12 Months | Every 3 months up to 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With A1C of <6.5% After CGM-guided Insulin Therapy Intervention | A1C measures every 3 months up to 1 year | 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. |
| Number of Patients With Glucose Values <55 mg/dL During 4 Week of Insulin and CGM Intervention | 4 weeks | 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 |
| See if Diabetes Distress is Affected With Intervention Via Problem Areas In Diabetes (PAID) - 5 Questionnaire Scale | 1 year | 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 |
| Percent Time Glucose Values Remain in Range While Wearing CGM During Insulin Intervention | 4 weeks | Use CGM-captured glucose values to determine how often a participant's glucose levels were in range (percent time in range) |
| Number of Participants Achieving Euglycemic Glucose Targets Within a 4 Week Period | 4 weeks | 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 |
Countries
United States
Participant flow
Recruitment details
Participants were identified using Pitt+Me, an online community which notifies patients about research studies they may be interested.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Insulin and CGM Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 7 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: Every 3 months up to 1 year
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin and CGM Intervention | Change in Baseline A1C and A1C Measured at 3 Month Intervals up to 12 Months | Pre-intervention | 9.00 percentage of glycosylated hemoglobin | Standard Deviation 1.56 |
| Insulin and CGM Intervention | Change in Baseline A1C and A1C Measured at 3 Month Intervals up to 12 Months | 3 months | 6.81 percentage of glycosylated hemoglobin | Standard Deviation 0.52 |
| Insulin and CGM Intervention | Change in Baseline A1C and A1C Measured at 3 Month Intervals up to 12 Months | 6 months | 7.13 percentage of glycosylated hemoglobin | Standard Deviation 1.43 |
| Insulin and CGM Intervention | Change in Baseline A1C and A1C Measured at 3 Month Intervals up to 12 Months | 9 months | 7.26 percentage of glycosylated hemoglobin | Standard Deviation 1.41 |
| Insulin and CGM Intervention | Change in Baseline A1C and A1C Measured at 3 Month Intervals up to 12 Months | 12 months | 6.88 percentage of glycosylated hemoglobin | Standard Deviation 1.2 |
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
Time frame: 4 weeks
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin and CGM Intervention | Number of Participants Achieving Euglycemic Glucose Targets Within a 4 Week Period | Fasting Glucose <95 mg/dL | 6 Participants |
| Insulin and CGM Intervention | Number of Participants Achieving Euglycemic Glucose Targets Within a 4 Week Period | 2hr post prandial glucose <120 mg/dL | 8 Participants |
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.
Time frame: A1C measures every 3 months up to 1 year
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin and CGM Intervention | Number of Participants With A1C of <6.5% After CGM-guided Insulin Therapy Intervention | 3 months | 1 Participants |
| Insulin and CGM Intervention | Number of Participants With A1C of <6.5% After CGM-guided Insulin Therapy Intervention | 6 months | 2 Participants |
| Insulin and CGM Intervention | Number of Participants With A1C of <6.5% After CGM-guided Insulin Therapy Intervention | 9 months | 2 Participants |
| Insulin and CGM Intervention | Number of Participants With A1C of <6.5% After CGM-guided Insulin Therapy Intervention | 12 months | 4 Participants |
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
Time frame: 4 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Insulin and CGM Intervention | Number of Patients With Glucose Values <55 mg/dL During 4 Week of Insulin and CGM Intervention | 4 Participants |
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)
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin and CGM Intervention | Percent Time Glucose Values Remain in Range While Wearing CGM During Insulin Intervention | Pre-intervention | 46.3 percentage of time in range | Standard Deviation 28.4 |
| Insulin and CGM Intervention | Percent Time Glucose Values Remain in Range While Wearing CGM During Insulin Intervention | Post-intervention | 80.67 percentage of time in range | Standard Deviation 10.7 |
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
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin and CGM Intervention | See if Diabetes Distress is Affected With Intervention Via Problem Areas In Diabetes (PAID) - 5 Questionnaire Scale | Pre-intervention | 8.90 units on a scale | Standard Deviation 3.66 |
| Insulin and CGM Intervention | See if Diabetes Distress is Affected With Intervention Via Problem Areas In Diabetes (PAID) - 5 Questionnaire Scale | Post-intervention | 7.62 units on a scale | Standard Deviation 4.35 |