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Pre-diabetesCGM PreDMNCT01741467

The Effect of Real Time Continuous Glucose Monitoring in Subjects With Pre-diabetes

A study testing RT-CGM in people with Pre-diabetes and Impaired Glucose Tolerance, run by Walter Reed National Military Medical Center 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

This study will investigate whether real-time continuous glucose monitoring can be used as a tool for behavior change in people with pre-diabetes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pre-diabetes, Impaired Glucose Tolerance
What is being tested?
RT-CGM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited States
Study dates
May 2012to Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

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 or older
  • Newly diagnosed with pre-diabetes (within the previous 6 months) with a FPG of > or = 110-125mg/dl or an A1c > or = 6% - 6.4%
  • Able to independently measure and read finger stick blood glucose levels
  • Willing to wear the CGM device for up to 12 weeks during the study period
  • Willing to test blood sugar by fingerstick twice per day while wearing the CGM
  • DEERS eligible

Who cannot join

  • Using medication for pre-diabetes
  • Women who are pregnant, lactating, planning to become pregnant, or without a safe contraceptive method; all female subjects will undergo pregnancy testing via a serum HcG with their initial blood testing.
  • Subjects who are taking glucocorticoids, amphetamines, anabolic, or weight-reducing agents during the course of the study.
  • Active Duty service members likely to be deployed during the 18-month study period.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

Other trials in United States

About this study

This study will investigate whether real-time continuous glucose monitoring can be used as a tool for behavior change in people with pre-diabetes.

Read the detailed description

The protocol is a prospective, non-blinded, randomized controlled study in persons with newly diagnosed pre-diabetes comparing the effects of real-time continuous glucose monitoring (RT-CGM) combined with diet and lifestyle education to those who have diet and lifestyle education alone. During a "wash-in" phase both groups will wear a masked CGM for 1 week at baseline and again after 12 weeks. Those randomized to the RT-CGM will wear it for 4 cycles of 2 week on/1 week off over the next 12 weeks. Both groups will follow-up with their primary care providers as clinically indicated over the next year with quarterly measurements of blood pressure, weight, and BMI. At the end of this period, they will wear a masked CGM for 1 week.

Being tested
RT-CGM
Medical subject headings
Glucose Intolerance

What participants receive

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

  • RT-CGMBehavioural

    Dexcom Seven+

Study groups in NCT01741467
Study groupRoleWhat they receive
RT-CGMExperimentalPatients using the RT-CGM for the intervention portion of the study.
Receives: Behavioral: RT-CGM

What is being measured

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

  1. Differences in blood glucose

    Changes in A1c and fasting blood glucose over time and between the intervention and control groups.

    Measured: baseline, 18 months

Secondary outcomes (6)

  1. Impact of lifestyle changes

    Evaluating the impact of lifestyle changes on levels of glycemic control in the control and experimental groups.

    Measured: baseline, 18 months

  2. Changes in Glucose dynamics

    Comparison of intervention and control group on standard measures of glucose dynamics.

    Measured: baseline, 18 months

  3. Differences in blood pressure.

    Objective comparison between the control and experimental group in changes in blood pressure.

    Measured: baseline, 18 months

  4. Differences in lipids.

    Objective comparison between the control group and the experimental group on changes in lipids.

    Measured: baseline, 18 months

  5. Differences in weight

    Objective comparison between the control group and the experimental group on changes in weight.

    Measured: baseline, 18 months

  6. Changes in medication use

    An objective comparison between the control and experimental group on changes in medication use.

    Measured: baseline, 18 months

Timeline

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

  1. First posted5 Dec 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionAug 2015
  4. Study completionAug 2016

Resources

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 N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01741467
Sponsor's protocol ID
369196
Acronym
CGM PreDM
Status last verified
Oct 2016
First submitted
19 Jul 2012
Last updated
19 Oct 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Diabetes Prevention Program Research Group. The prevalence of retinopathy in impaired glucose tolerance and recent-onset diabetes in the Diabetes Prevention Program. Diabet Med. 2007 Feb;24(2):137-44. doi: 10.1111/j.1464-5491.2007.02043.x.

    PubMed 17257275

  • Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.

    PubMed 11832527

  • Yamaoka K, Tango T. Efficacy of lifestyle education to prevent type 2 diabetes: a meta-analysis of randomized controlled trials. Diabetes Care. 2005 Nov;28(11):2780-6. doi: 10.2337/diacare.28.11.2780.

    PubMed 16249558

  • Salpeter SR, Buckley NS, Kahn JA, Salpeter EE. Meta-analysis: metformin treatment in persons at risk for diabetes mellitus. Am J Med. 2008 Feb;121(2):149-157.e2. doi: 10.1016/j.amjmed.2007.09.016.

    PubMed 18261504

  • DeFronzo RA, Tripathy D, Schwenke DC, Banerji M, Bray GA, Buchanan TA, Clement SC, Henry RR, Hodis HN, Kitabchi AE, Mack WJ, Mudaliar S, Ratner RE, Williams K, Stentz FB, Musi N, Reaven PD; ACT NOW Study. Pioglitazone for diabetes prevention in impaired glucose tolerance. N Engl J Med. 2011 Mar 24;364(12):1104-15. doi: 10.1056/NEJMoa1010949.

    PubMed 21428766

  • Chiasson JL. Acarbose for the prevention of diabetes, hypertension, and cardiovascular disease in subjects with impaired glucose tolerance: the Study to Prevent Non-Insulin-Dependent Diabetes Mellitus (STOP-NIDDM) Trial. Endocr Pract. 2006 Jan-Feb;12 Suppl 1:25-30. doi: 10.4158/EP.12.S1.25.

    PubMed 16627376

  • Van de Laar FA, Lucassen PL, Akkermans RP, Van de Lisdonk EH, De Grauw WJ. Alpha-glucosidase inhibitors for people with impaired glucose tolerance or impaired fasting blood glucose. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD005061. doi: 10.1002/14651858.CD005061.pub2.

    PubMed 17054235

  • Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Hirsch IB, Huang ES, Kollman C, Kowalski AJ, Laffel L, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer S, Wilson DM, Wolpert H, Wysocki T, Xing D. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008 Oct 2;359(14):1464-76. doi: 10.1056/NEJMoa0805017. Epub 2008 Sep 8.

    PubMed 18779236

  • Battelino T, Phillip M, Bratina N, Nimri R, Oskarsson P, Bolinder J. Effect of continuous glucose monitoring on hypoglycemia in type 1 diabetes. Diabetes Care. 2011 Apr;34(4):795-800. doi: 10.2337/dc10-1989. Epub 2011 Feb 19.

    PubMed 21335621

  • Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Bode B, Beck RW, Xing D, Gilliam L, Hirsch I, Kollman C, Laffel L, Ruedy KJ, Tamborlane WV, Weinzimer S, Wolpert H. Sustained benefit of continuous glucose monitoring on A1C, glucose profiles, and hypoglycemia in adults with type 1 diabetes. Diabetes Care. 2009 Nov;32(11):2047-9. doi: 10.2337/dc09-0846. Epub 2009 Aug 12.

    PubMed 19675193

  • Vigersky RA, Fonda SJ, Chellappa M, Walker MS, Ehrhardt NM. Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes. Diabetes Care. 2012 Jan;35(1):32-8. doi: 10.2337/dc11-1438. Epub 2011 Nov 18.

    PubMed 22100963

  • Diabetes Prevention Program Research Group. The 10-year cost-effectiveness of lifestyle intervention or metformin for diabetes prevention: an intent-to-treat analysis of the DPP/DPPOS. Diabetes Care. 2012 Apr;35(4):723-30. doi: 10.2337/dc11-1468.

    PubMed 22442395

  • American Diabetes Association. Standards of medical care in diabetes--2011. Diabetes Care. 2011 Jan;34 Suppl 1(Suppl 1):S11-61. doi: 10.2337/dc11-S011. No abstract available.

    PubMed 21193625

Questions about this trial

What is this clinical trial studying?

A study testing RT-CGM in people with Pre-diabetes and Impaired Glucose Tolerance, run by Walter Reed National Military Medical Center 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 6 inclusion and 4 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 19 Oct 2016. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Differences in blood glucose (time frame: baseline, 18 months). 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 NCT01741467, which also lists 13 linked publications.

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 19 Oct 2016.

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