Type 2 Diabetes MellitusPhase 4REMIT-DMNCT03670641

Remission Through Early Monitored Insulin Therapy - Duration Month

A Phase 4 study testing Glargine, Lispro and Dexcom G6 in people with Type 2 Diabetes Mellitus, run by Sandra Sobel at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Glargine, Lispro and Dexcom G6
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 26 Mar 2019to 31 Jul 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥18
A1C criteria - >7.0
Newly diagnosed with T2D within 4 years
Lifestyle controlled
Subject may be on up to 2 medications for diabetes.
Smart phone or home computer compatible with DEXCOM CLARITY software
English speaking
Assessed by endocrinologist and diabetes educator to be able to perform skills necessary for CGM use and insulin delivery

Who cannot join

Autoimmune Type 1 DM, defined as positive GAD65 or islet cell antibodies
Pregnant
Chronic Kidney Disease (CKD) Stage IV or greater
Mental and/or cognitive disorder (based on documented disorder and/or assessment of physician or educator)
No access to computer for downloading CGM
BMI <18.0

Trial locations and contacts

1 site in 1 country.

United States1 site

UPMC Falk Diabetes Clinic
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Read the 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.

Conditions: Type 2 Diabetes Mellitus
Being tested: Glargine, Lispro, Dexcom G6
Keywords: Insulin therapy, Continuous glucose monitor
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GlargineDrug
Also called 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.
LisproDrug
Also called 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.
Dexcom G6Device
Also called CGM
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.

Study groups in NCT03670641
Study group	Role	What they receive
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. Receives: Drug: Glargine; Drug: Lispro; Device: Dexcom G6

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Every 3 months up to 1 year

Secondary outcomes (5)

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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 201931 Jul 2020

First posted13 Sep 2018
Study start26 Mar 2019
Primary completion31 Jul 2020
Study completion31 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03670641
Sponsor's protocol ID: PRO17110070
Acronym: REMIT-DM
Status last verified: Sep 2021
First submitted: 6 Sep 2018
Last updated: 12 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Remission Through Early Monitored Insulin Therapy - Duration Month
ClinicalTrials.gov ID: NCT03670641
Acronym / sponsor ID: REMIT-DM / PRO17110070
Conditions: Type 2 Diabetes Mellitus
Keywords: Insulin therapy, Continuous glucose monitor
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Sandra SobelUniversity, hospital or other
Study start: 26 Mar 2019 (actual)
Primary completion: 31 Jul 2020 (actual)
Study completion: 31 Jul 2020 (actual)
First posted: 13 Sep 2018 (actual)
Results: Posted 12 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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

Arm	Type	Receives
Insulin and CGM Intervention	Experimental	Drug: Glargine, Drug: Lispro, Device: Dexcom G610 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age ≥18
A1C criteria - >7.0
Newly diagnosed with T2D within 4 years
Lifestyle controlled
Subject may be on up to 2 medications for diabetes.

Key exclusion criteria (6 listed)

Autoimmune Type 1 DM, defined as positive GAD65 or islet cell antibodies
Pregnant
Chronic Kidney Disease (CKD) Stage IV or greater
Mental and/or cognitive disorder (based on documented disorder and/or assessment of physician or educator)
No access to computer for downloading CGM

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GlargineAlso: LantusDexcom 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.	Drug	Insulin and CGM Intervention
LisproAlso: HumalogDexcom 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.	Drug	Insulin and CGM Intervention
Dexcom G6Also: CGMDexcom 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.	Device	Insulin and CGM Intervention

Primary outcome

Change in Baseline A1C and A1C Measured at 3 Month Intervals up to 12 Months
Time frame: 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.

5 secondary outcomes

Number of Participants With A1C of <6.5% After CGM-guided Insulin Therapy Intervention
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
Time frame: 4 weeks
See if Diabetes Distress is Affected With Intervention Via Problem Areas In Diabetes (PAID) - 5 Questionnaire Scale
Time frame: 1 year
Percent Time Glucose Values Remain in Range While Wearing CGM During Insulin Intervention
Time frame: 4 weeks
Number of Participants Achieving Euglycemic Glucose Targets Within a 4 Week Period
Time frame: 4 weeks

Results and safety

Results posted to the registry on 12 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Insulin and CGM Intervention	10	7

Primary outcome: Change in Baseline A1C and A1C Measured at 3 Month Intervals up to 12 Months

Time frame: Every 3 months up to 1 year. Mean (Standard Deviation). Unit: percentage of glycosylated hemoglobin

Measure	Insulin and CGM Intervention n = 10
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)

Population analysed: 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

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year post enrollment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin and CGM Intervention	0 of 10 (0%)	7 of 10 (70%)	0 of 10

Limitations and caveats (from the sponsor): Statistical analyses beyond those reported here were not conducted due to low number of participants enrolled

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sandra I Sobel, MD principal investigator

University of Pittsburgh

David A Rometo, MD principal investigator

University of Pittsburgh

Linda Siminerio, RN PhD principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Glargine, Lispro and Dexcom G6 in people with Type 2 Diabetes Mellitus, run by Sandra Sobel at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Baseline A1C and A1C Measured at 3 Month Intervals up to 12 Months (time frame: Every 3 months up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03670641.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.