Type 1 Diabetes MellitusNCT01083433

Study to Find Out if Intensive Diabetes Clinic and Continuous Glucose Monitors Help Teenagers With Diabetes

A study testing Diabetes related psychological counseling and education and Continuous Glucose Monitor in people with Type 1 Diabetes Mellitus, run by University Hospitals Cleveland 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

Search all trials

Trial summary

Who is it for?: Ages 10 to 18 years
Conditions the study is for: Type 1 Diabetes Mellitus
What is being tested?: Diabetes related psychological counseling and education and Continuous Glucose Monitor
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteUnited States
Study dates: May 2010to Oct 2011
Phase: Interventional
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 10 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Type 1 diabetes mellitus of at least 12 months duration, followed by Rainbow Babies and Children's Pediatric Endocrinology and Diabetes Division
Most recent HbA1c >= 8.5%
Patients must be willing to check their blood sugar at least 4 times daily while wearing the CGM
Patients and families must be willing to come to diabetes clinic once a month for 4 months

Who cannot join

Inability to understand and/or speak the English language
Pregnancy
Psychological counseling with Dr. Rebecca Hazen regarding diabetes adherence prior to the study

Trial locations and contacts

1 site in 1 country.

United States1 site

UHCMC
Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: Intensive Diabetes Clinic and Intermittent Continuous Glucose Monitoring in Adolescents With Type 1 Diabetes Mellitus in Poor Glycemic Control

The purpose of this research study is to find out ways to help pre-teens and teens and their families to improve diabetes control and to help with the burden of diabetes management. Specifically, the study aims to find out if coming to diabetes clinic more frequently and for a longer period of time helps adolescents with diabetes, and if adolescents who wear a continuous glucose monitor (CGM) for 3-5 days a month will have better diabetes control.

Read the detailed description

Good glycemic control is critical in preventing chronic complications of type 1 diabetes. However, achieving good glycemic control remains elusive for many adolescents. This study evaluates two clinic-based approaches for improving glycemic control in adolescents with poorly controlled type 1 diabetes - an intensive diabetes support and education program alone and the same intensive diabetes support and education program together with continuous glucose monitoring - in comparison with standard diabetes care.

Conditions: Type 1 Diabetes Mellitus
Being tested: Diabetes related psychological counseling and education, Continuous Glucose Monitor
Keywords: Continuous Glucose Monitor, Adherence, Adolescents, Diabetes Education
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

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

Diabetes related psychological counseling and educationBehavioural
Also called Diabetes Education, Diabetes Psychological Counseling
The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
Continuous Glucose MonitorDevice
Also called Medtronic Minimed iPro
Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months.

Study groups in NCT01083433
Study group	Role	What they receive
Standard Diabetes Care	No intervention	Patients will attend diabetes clinic as usual, once every 3 months.
Intensive Diabetes Clinic	Experimental	Patients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist. Receives: Behavioral: Diabetes related psychological counseling and education
Intensive Diabetes Clinic plus CGM	Experimental	Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a continuous glucose monitor for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM. Receives: Behavioral: Diabetes related psychological counseling and education; Device: Continuous Glucose Monitor

What is being measured

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

Glycemic Control
Serum hemoglobin A1c (HbA1c) will be measured in all groups at the baseline visit and visit 4.
Measured: Baseline and visit 4

Secondary outcomes (5)

Insulin Dose Changes
Insulin doses in units per kilogram per day will be calculated at baseline and visit 4.
Measured: Baseline and visit 4
Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL)
CGM downloads at baseline and visit 4 will be used to tabulate the number of episodes of blood glucoses < 70 mg/dL. At each visit patients will be asked to recall any episodes of severe hypoglycemia that occurred since the last visit. Data from the continuous glucose monitors will be used to evaluate the percent of time that patients are below 70 mg/dL and the number of glucose excursions below 70 mg/dL. Total number of excursions under 70 mg/dL from baseline to visit 4 will be added together.
Measured: Total from baseline to visit 4
Adherence to Prescribed Diabetes Regimen
Diabetes Self Management Profile, given to participant (child) at baseline and visit 4. Minimum score zero, maximum score 88. A higher score indicates better adherence. The DSMP is a 10-15 minute, 25-question, validated, structured interview of adherence with diabetes self-management tasks administered separately to parents and youth. It was verbally administered by one pediatric endocrinologist and one trained research assistant. It assesses self-management of exercise and hypoglycemia (7 questions), carbohydrate counting and insulin dose calculation (6 questions), blood glucose and ketone monitoring (8 questions), and insulin timing and dosing (4 questions).
Measured: Baseline and visit 4
Satisfaction With Intensive Diabetes Clinic and Usage of the Continuous Glucose Monitor
Survey of patient and parent satisfaction in the interventions groups only, satisfaction with the overall study including CGM use and psychological intervention. Satisfaction measured on a 7 point Likert scale, with highest satisfaction at a score of 7 and lowest score 1.
Measured: Visit 4
Diabetes Knowledge
The Diabetes Knowledge Questionnaire was adapted from Butler et al. It is a written questionnaire, self administered independently to parents and children to assess their knowledge about diabetes management. It includes 37 multiple choice questions assessing basic information about diabetes, how to deal with diabetes-related tasks, and management of hypothetical situations. A total score out of 37 possible points is computed for diabetes knowledge, score can range from 0-37. A higher score indicates higher knowledge.
Measured: Baseline and month 4

Timeline

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

May 2010Oct 2011

First posted9 Mar 2010 (estimated)
Study startMay 2010
Primary completionSep 2011
Study completionOct 2011

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.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01083433
Sponsor's protocol ID: RBCDM-01
Other IDs: MH018830
Status last verified: Jan 2022
First submitted: 8 Mar 2010
Last updated: 13 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
PubMed 8366922
Monnier L, Mas E, Ginet C, Michel F, Villon L, Cristol JP, Colette C. Activation of oxidative stress by acute glucose fluctuations compared with sustained chronic hyperglycemia in patients with type 2 diabetes. JAMA. 2006 Apr 12;295(14):1681-7. doi: 10.1001/jama.295.14.1681.
PubMed 16609090
Monnier L, Colette C. Glycemic variability: should we and can we prevent it? Diabetes Care. 2008 Feb;31 Suppl 2:S150-4. doi: 10.2337/dc08-s241.
PubMed 18227477
Weber C, Schnell O. The assessment of glycemic variability and its impact on diabetes-related complications: an overview. Diabetes Technol Ther. 2009 Oct;11(10):623-33. doi: 10.1089/dia.2009.0043.
PubMed 19821754
El-Osta A, Brasacchio D, Yao D, Pocai A, Jones PL, Roeder RG, Cooper ME, Brownlee M. Transient high glucose causes persistent epigenetic changes and altered gene expression during subsequent normoglycemia. J Exp Med. 2008 Sep 29;205(10):2409-17. doi: 10.1084/jem.20081188. Epub 2008 Sep 22.
PubMed 18809715
Hirsch IB. Glycemic variability: it's not just about A1C anymore! Diabetes Technol Ther. 2005 Oct;7(5):780-3. doi: 10.1089/dia.2005.7.780. No abstract available.
PubMed 16241882
Monnier L, Colette C, Owens DR. Glycemic variability: the third component of the dysglycemia in diabetes. Is it important? How to measure it? J Diabetes Sci Technol. 2008 Nov;2(6):1094-100. doi: 10.1177/193229680800200618.
PubMed 19885298
Deiss D, Bolinder J, Riveline JP, Battelino T, Bosi E, Tubiana-Rufi N, Kerr D, Phillip M. Improved glycemic control in poorly controlled patients with type 1 diabetes using real-time continuous glucose monitoring. Diabetes Care. 2006 Dec;29(12):2730-2. doi: 10.2337/dc06-1134. No abstract available.
PubMed 17130215
Schaepelynck-Belicar P, Vague P, Simonin G, Lassmann-Vague V. Improved metabolic control in diabetic adolescents using the continuous glucose monitoring system (CGMS). Diabetes Metab. 2003 Dec;29(6):608-12. doi: 10.1016/s1262-3636(07)70076-9.
PubMed 14707890
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

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?

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All Type 1 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intensive Diabetes Clinic and Intermittent Continuous Glucose Monitoring in Adolescents With Type 1 Diabetes Mellitus in Poor Glycemic Control
ClinicalTrials.gov ID: NCT01083433
Acronym / sponsor ID: RBCDM-01
Conditions: Type 1 Diabetes Mellitus
Keywords: Continuous Glucose Monitor, Adherence, Adolescents, Diabetes Education
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: University Hospitals Cleveland Medical CenterUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: May 2010
Primary completion: Sep 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 9 Mar 2010 (estimated)
Results: Posted 13 Jan 2022

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Standard Diabetes Care	No intervention	–Patients will attend diabetes clinic as usual, once every 3 months.
Intensive Diabetes Clinic	Experimental	Behavioral: Diabetes related psychological counseling and educationPatients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist.
Intensive Diabetes Clinic plus CGM	Experimental	Behavioral: Diabetes related psychological counseling and education, Device: Continuous Glucose MonitorPatients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a continuous glucose monitor for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.

Who may qualify

Ages: 10 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Type 1 diabetes mellitus of at least 12 months duration, followed by Rainbow Babies and Children's Pediatric Endocrinology and Diabetes Division
Most recent HbA1c >= 8.5%
Patients must be willing to check their blood sugar at least 4 times daily while wearing the CGM
Patients and families must be willing to come to diabetes clinic once a month for 4 months

Key exclusion criteria (3 listed)

Inability to understand and/or speak the English language
Pregnancy
Psychological counseling with Dr. Rebecca Hazen regarding diabetes adherence prior to the study

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
Diabetes related psychological counseling and educationAlso: Diabetes Education, Diabetes Psychological CounselingThe psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.	Behavioural	Intensive Diabetes Clinic, Intensive Diabetes Clinic plus CGM
Continuous Glucose MonitorAlso: Medtronic Minimed iProPatients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months.	Device	Intensive Diabetes Clinic plus CGM

Primary outcome

Glycemic Control
Time frame: Baseline and visit 4
Serum hemoglobin A1c (HbA1c) will be measured in all groups at the baseline visit and visit 4.

5 secondary outcomes

Insulin Dose Changes
Time frame: Baseline and visit 4
Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL)
Time frame: Total from baseline to visit 4
Adherence to Prescribed Diabetes Regimen
Time frame: Baseline and visit 4
Satisfaction With Intensive Diabetes Clinic and Usage of the Continuous Glucose Monitor
Time frame: Visit 4
Diabetes Knowledge
Time frame: Baseline and month 4

Results and safety

Results posted to the registry on 13 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Diabetes Care	22	20
Intensive Diabetes Clinic	23	17
Intensive Diabetes Clinic Plus CGM	23	18

Primary outcome: Glycemic Control

Time frame: Baseline and visit 4. Mean (Standard Deviation). Unit: percent HbA1c

Measure	Standard Diabetes Care n = 20	Intensive Diabetes Clinic n = 17	Intensive Diabetes Clinic Plus CGM n = 18
VISIT 4	10.8 (2.2)	9.43 (1.1)	9.4 (0.9)
BASELINE	11.0 (2.1)	9.93 (1.3)	10.0 (1.4)

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Diabetes Care	4 of 22 (18.2%)	1 of 22 (4.5%)	0 of 22
Intensive Diabetes Clinic	1 of 23 (4.3%)	0 of 23 (0%)	0 of 23
Intensive Diabetes Clinic Plus CGM	2 of 23 (8.7%)	0 of 23 (0%)	0 of 23

Limitations and caveats (from the sponsor): * High rate of attrition and lack of outcome data in patients lost to follow-up. * Lack of CGM alone group

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8366922Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
Background: PubMed 16609090Monnier L, Mas E, Ginet C, Michel F, Villon L, Cristol JP, Colette C. Activation of oxidative stress by acute glucose fluctuations compared with sustained chronic hyperglycemia in patients with type 2 diabetes. JAMA. 2006 Apr 12;295(14):1681-7. doi: 10.1001/jama.295.14.1681.
Background: PubMed 18227477Monnier L, Colette C. Glycemic variability: should we and can we prevent it? Diabetes Care. 2008 Feb;31 Suppl 2:S150-4. doi: 10.2337/dc08-s241.
Background: PubMed 19821754Weber C, Schnell O. The assessment of glycemic variability and its impact on diabetes-related complications: an overview. Diabetes Technol Ther. 2009 Oct;11(10):623-33. doi: 10.1089/dia.2009.0043.
Background: PubMed 18809715El-Osta A, Brasacchio D, Yao D, Pocai A, Jones PL, Roeder RG, Cooper ME, Brownlee M. Transient high glucose causes persistent epigenetic changes and altered gene expression during subsequent normoglycemia. J Exp Med. 2008 Sep 29;205(10):2409-17. doi: 10.1084/jem.20081188. Epub 2008 Sep 22.
Background: PubMed 16241882Hirsch IB. Glycemic variability: it's not just about A1C anymore! Diabetes Technol Ther. 2005 Oct;7(5):780-3. doi: 10.1089/dia.2005.7.780. No abstract available.
Background: PubMed 19885298Monnier L, Colette C, Owens DR. Glycemic variability: the third component of the dysglycemia in diabetes. Is it important? How to measure it? J Diabetes Sci Technol. 2008 Nov;2(6):1094-100. doi: 10.1177/193229680800200618.
Background: PubMed 17130215Deiss D, Bolinder J, Riveline JP, Battelino T, Bosi E, Tubiana-Rufi N, Kerr D, Phillip M. Improved glycemic control in poorly controlled patients with type 1 diabetes using real-time continuous glucose monitoring. Diabetes Care. 2006 Dec;29(12):2730-2. doi: 10.2337/dc06-1134. No abstract available.
Background: PubMed 14707890Schaepelynck-Belicar P, Vague P, Simonin G, Lassmann-Vague V. Improved metabolic control in diabetic adolescents using the continuous glucose monitoring system (CGMS). Diabetes Metab. 2003 Dec;29(6):608-12. doi: 10.1016/s1262-3636(07)70076-9.
Background: PubMed 18779236Juvenile 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.

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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.

Sarah A MacLeish, D.O. principal investigator

UHCMC Division of Pediatric Endocrinology

Rebecca A Hazen, Ph.D. principal investigator

UHCMC Division of Behavioral Pediatrics

Leona Cuttler, M.D principal investigator

UHCMC Division of Pediatric Endocrinology

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

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 3 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 13 Jan 2022. 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?

Yes. Results are posted in the registry (first posted 13 Jan 2022). 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?

Glycemic Control (time frame: Baseline and visit 4). 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 NCT01083433, which also lists 10 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 13 Jan 2022.