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Welcome to the Barbara Davis Center for Diabetes at the University of Colorado School of Medicine on the Anschutz Medical Campus in Aurora, Colorado.

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Clinical Research Studies

Prevention and Intervention Trials for Patients

The Barbara Davis Center for Diabetes, located at the University of Colorado Anschutz Medical Campus, is actively involved in clinical research. The research division has several on-going studies, as well as ones that are opn for enrollment. These studies are all dedicated to the pursuit of preventing diabetes in high-risk patients as well as clinical intervention with those already diagnosed with Type 1 diabetes.

The following studies are currently enrolling eligible participants.

Currently Enrolling Studies for Children with Diabetes
COMIRB number: 13-2765/approval date: Nov 5, 2013 Novo BOOST. A trial investigating the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals versus insulin detemir once or twice daily plus meal time insulin aspart in children and adolescents with type 1 diabetes mellitus. Inclusion criteria: Have type 1 diabetes Between 1 and 17 years old Have been using insulin for at least three months Principal Investigator: Paul Wadwa Study Coordinator: Leena Nguyen, 303-724-5554
COMIRB number: 13-2350/approval date: Nov 5, 2013 Assessment of intranasal glucagon in children and adolescents with type 1 diabetes to treat hypoglycemia Inclusion criteria: Have type 1 diabetes Between 4 and 16 years old Have been using insulin for at least 12 months Weigh at least 34 pounds Principal Investigator: Paul Wadwa Study Coordinator: Leena Nguyen, 303-724-5554
COMIRB number: PTL-900740/ approval date: Jan 22, 2014 YSI Feasibility Study of the Dexcom™ CGM System in Adults and Pediatrics with Diabetes Mellitus Inclusion criteria: Children ages 6-17 with Type 1 Diabetes who are willing to wear a Dexcom system and participate in up to an 8 hour clinic session. Principal Investigators: Peter Chase Study Coordinator: Emily Westfall
COMIRB number: 14-0347/ approval date: May 11, 2014 FL3X – Flexible Lifestyle 3mpoweing Change. Purpose of this research study is to develop new ways of helping teens manage their diabetes. www.type1FL3X.com. Inclusion criteria: Patient at the Barbara Davis Center. Between 13 and 16 years old Type 1 diabetes for longer than 1 year HbA1c between 8-13% Principal Investigators: David Maahs Study Coordinator: Franziska Bishop, 303-724-6764

Currently Enrolling Studies for Children and Adults with Type 1 Diabetes
COMIRB number: 13-2652/ approval date: Dec 11, 2013 Gleevec- Safety and Efficacy of Imatinib for Preserving Beta-cell Function in New-onset Type 1 Diabetes Mellitus Goal: The purpose of this trial is to test whether a drug called Gleevec (Imatinib) will slow or halt destruction of the beta cells in the pancreas. Inclusion criteria: Ages 12-45 (Adults and then children) Within 100 days of diagnosis with type 1 diabetes Confirmed type 1 diabetes Principal Investigator: Peter Gottlieb Study Coordinators: Lisa Meyers, 303-724-6732 & Jennifer Smith, 303-724-8272 & Aaron Blau, 303-724-6894
WIRB Number: 13-0072/ Approval date: 12/20/13 Secukinumab- A Randomized, Double-Blind, Multiple Dose, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Immunogeniciy, Pharmacokinetics, and Efficacy of Secukininumab in Adult and Pediatric Patients wih New-Onset Type 1 Diabetes Mellis (T1D). Sponsor Protocol # CAIN457A2227. WIRB Protocol #. 20130083 Goal: To test whether a drug called Secukinumab will slow or halt destruction of the beta cells in the pancreas. Inclusion Criteria: Ages 8-35 (staggered enrollment- Adults, then adolescents and then children) Within 100 days of diagnosis with type 1 diabetes Confirmed type 1 diabetes Principal Investigator: Peter Gottlieb Study Coordinators: Lisa Meyers, 303-724-6732 & Jennifer Smith, 303-724-8272 & Aaron Blau, 303-724-6894
COMIRB number: 13-1457/ approval date: May 24, 2013 Outpatient Reduction of Nocturnal Hypoglycemia By Using algorithms and Pump Suspension Inclusion Criteria: Children and adults with Type 1 Diabetes who use wear an insulin pump and CGM and are interested in using a computer to help regulate blood sugars overnight at home. Principal Investigators: David Maahs & Peter Chase Study Coordinator: Dena Gottesman
COMIRB number: 13-2759/ approval date: Dec 13, 2013 Evaluation of Glucose Sensor and Insulin Infusion Set Failures: Lipohypertrophy Study Inclusion Criteria: Children and adults (12-45 y/o) with Type 1 Diabetes who have lipohypertrophy (≥3cm) and wear an insulin pump who are willing to wear two Dexcoms over a 4 week study period. Principal Investigator: David Maahs Study Coordinator: Laurel Messer
COMIRB number: 13-2668/ approval date: Oct 25, 2013 Early Diagnosis of Change in GFR in Adolescents with Type 1 Diabetes by Iohexol Clearance. Criteria Inclusion: have type 1 diabetes between ages 12-25 normal blood pressure normal kidney function Principal Investigator: David Maahs Study Coordinator: Vicky Gage, 303-724-8369
Currently Enrolling Studies for Adults with Type 1 Diabetes
COMIRB number: 13-2351/ approval date: Nov 26, 2013 A trial investigating the efficacy and safety of intranasal glucagon for treatment of insulin induced hypoglycemia in adults with diabetes Inclusion criteria: Have type 1 diabetes Between 18 and 64 years old Have been using insulin for at least 2 years Weigh at least 110 pounds Principal Investigator: Paul Wadwa Study Coordinator: Leena Nguyen, 303-724-5554
COMIRB number: 13-1408/ approval date: May 25, 2013 The Effect of Methyldopa on MHC class II antigen presentation in type 1 diabetes Inclusion Criteria: Ages 18-46 years old Diagnosed with type 1 diabetes within the last 2 years Be willing to take methyldopa, an oral medication, for 6 weeks Participate in 6 visits at the Barbara Davis Center over 3 months Principal Investigator: Aaron Michels Study Coordinator: Aimon Alkanan
COMIRB number: 13-2457/ approval date: Nov 11, 2013 PERL: Preventing Early Renal Loss in Diabetes. Adult clinical trial to determine whether lowering serum uric acid by means of allopurinol early in the course of kidney disease may be effective in preventing or slowing the decline of renal function in T1D patients. Inclusion Criteria Diagnosed with type 1 diabetes before age 35 T1D for >8 years Ages 18-65 History or presence of microalbuminuria Estimated GFR (eGFR) between 45-99.9 Serum Uric Acid >4.5 mg/dl Principal Investigator: David Maahs Study Coordinator: Vicky Gage, 303-724-8369
COMIRB number: 13-2824/ approval date: Dec 18, 2013 Exenatide (Bydureon) Goal: The goal of this trial is to test whether a drug called Exenatide (Bydureon), typically used to treat type 2 diabetes, will help people with type 1 diabetes improve their blood glucose levels. Inclusion Criteria: Ages 18-60 Confirmed T1D for at least 2 years Insulin requirements of no more than 0.9 units/kg/day No DKA previous 6 months A1c less than or equal to 9.0% Principal Investigator: Peter Gottlieb Study Coordinators: Lisa Meyers, 303-724-6732 & Jennifer Smith, 303-724-8272 & Aaron Blau, 303-724-6894

Currently Enrolling Studies for Children with Diabetes

COMIRB number: 13-2765/approval date: Nov 5, 2013

Novo BOOST. A trial investigating the efficacy and safety of insulin degludec/insulin aspart once daily plus
insulin aspart for the remaining meals versus insulin detemir once or twice daily plus meal time insulin aspart in children and adolescents with type 1 diabetes mellitus.

Inclusion criteria:

Have type 1 diabetes

Between 1 and 17 years old

Have been using insulin for at least three months

Principal Investigator: Paul Wadwa

Study Coordinator: Leena Nguyen, 303-724-5554

COMIRB number: 13-2350/approval date: Nov 5, 2013

Assessment of intranasal glucagon in children and adolescents with type 1 diabetes to treat hypoglycemia

Inclusion criteria:

Have type 1 diabetes

Between 4 and 16 years old

Have been using insulin for at least 12 months

Weigh at least 34 pounds

Principal Investigator: Paul Wadwa

Study Coordinator: Leena Nguyen, 303-724-5554

COMIRB number: PTL-900740/ approval date: Jan 22, 2014

YSI Feasibility Study of the Dexcom™ CGM System in Adults and Pediatrics with Diabetes Mellitus

Inclusion criteria:

Children ages 6-17 with Type 1 Diabetes who are willing to wear a Dexcom system and participate in up to an 8 hour clinic session.

Principal Investigators: Peter Chase

Study Coordinator: Emily Westfall

COMIRB number: 14-0347/ approval date: May 11, 2014

FL3X – Flexible Lifestyle 3mpoweing Change. Purpose of this research study is to develop new ways of helping teens manage their diabetes. www.type1FL3X.com.

Inclusion criteria:

Patient at the Barbara Davis Center.

Between 13 and 16 years old

Type 1 diabetes for longer than 1 year

HbA1c between 8-13%

Principal Investigators: David Maahs

Study Coordinator: Franziska Bishop, 303-724-6764

Currently Enrolling Studies for Children and Adults with Type 1 Diabetes

COMIRB number: 13-2652/ approval date: Dec 11, 2013

Gleevec- Safety and Efficacy of Imatinib for Preserving Beta-cell Function in New-onset Type 1 Diabetes Mellitus

Goal: The purpose of this trial is to test whether a drug called Gleevec (Imatinib) will slow or halt destruction of the beta cells in the pancreas.

Inclusion criteria:

Ages 12-45 (Adults and then children)

Within 100 days of diagnosis with type 1 diabetes

Confirmed type 1 diabetes

Principal Investigator: Peter Gottlieb

Study Coordinators: Lisa Meyers, 303-724-6732 & Jennifer Smith, 303-724-8272 & Aaron Blau, 303-724-6894

WIRB Number: 13-0072/ Approval date: 12/20/13

Secukinumab- A Randomized, Double-Blind, Multiple Dose, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Immunogeniciy, Pharmacokinetics, and Efficacy of Secukininumab in Adult and Pediatric Patients wih New-Onset Type 1 Diabetes Mellis (T1D). Sponsor Protocol # CAIN457A2227. WIRB Protocol #. 20130083

Goal: To test whether a drug called Secukinumab will slow or halt destruction of the beta cells in the pancreas.

Inclusion Criteria:

Ages 8-35 (staggered enrollment- Adults, then adolescents and then children)

Within 100 days of diagnosis with type 1 diabetes

Confirmed type 1 diabetes

Principal Investigator: Peter Gottlieb

Study Coordinators: Lisa Meyers, 303-724-6732 & Jennifer Smith, 303-724-8272 & Aaron Blau, 303-724-6894

COMIRB number: 13-1457/ approval date: May 24, 2013

Outpatient Reduction of Nocturnal Hypoglycemia By Using algorithms and Pump Suspension

Inclusion Criteria:

Children and adults with Type 1 Diabetes who use wear an insulin pump and CGM and are interested in using a computer to help regulate blood sugars overnight at home.

Principal Investigators: David Maahs & Peter Chase

Study Coordinator: Dena Gottesman

COMIRB number: 13-2759/ approval date: Dec 13, 2013

Evaluation of Glucose Sensor and Insulin Infusion Set Failures: Lipohypertrophy Study

Inclusion Criteria:

Children and adults (12-45 y/o) with Type 1 Diabetes who have lipohypertrophy (≥3cm) and wear an insulin pump who are willing to wear two Dexcoms over a 4 week study period.

Principal Investigator: David Maahs

Study Coordinator: Laurel Messer

COMIRB number: 13-2668/ approval date: Oct 25, 2013

Early Diagnosis of Change in GFR in Adolescents with Type 1 Diabetes by Iohexol Clearance.

Criteria Inclusion:

have type 1 diabetes

between ages 12-25

normal blood pressure

normal kidney function

Principal Investigator: David Maahs

Study Coordinator: Vicky Gage, 303-724-8369

Currently Enrolling Studies for Adults with Type 1 Diabetes

COMIRB number: 13-2351/ approval date: Nov 26, 2013

A trial investigating the efficacy and safety of intranasal glucagon for treatment of insulin induced hypoglycemia in adults with diabetes

Inclusion criteria:

Have type 1 diabetes

Between 18 and 64 years old

Have been using insulin for at least 2 years

Weigh at least 110 pounds

Principal Investigator: Paul Wadwa

Study Coordinator: Leena Nguyen, 303-724-5554

COMIRB number: 13-1408/ approval date: May 25, 2013

The Effect of Methyldopa on MHC class II antigen presentation in type 1 diabetes

Inclusion Criteria:

Ages 18-46 years old

Diagnosed with type 1 diabetes within the last 2 years

Be willing to take methyldopa, an oral medication, for 6 weeks

Participate in 6 visits at the Barbara Davis Center over 3 months

Principal Investigator: Aaron Michels

Study Coordinator: Aimon Alkanan

COMIRB number: 13-2457/ approval date: Nov 11, 2013

PERL: Preventing Early Renal Loss in Diabetes.

Adult clinical trial to determine whether lowering serum uric acid by means of allopurinol early in the course of kidney disease may be effective in preventing or slowing the decline of renal function in T1D patients.

Inclusion Criteria

Diagnosed with type 1 diabetes before age 35

T1D for >8 years

Ages 18-65

History or presence of microalbuminuria

Estimated GFR (eGFR) between 45-99.9

Serum Uric Acid >4.5 mg/dl

Principal Investigator: David Maahs

Study Coordinator: Vicky Gage, 303-724-8369

COMIRB number: 13-2824/ approval date: Dec 18, 2013

Exenatide (Bydureon)

Goal: The goal of this trial is to test whether a drug called Exenatide (Bydureon), typically used to treat type 2 diabetes, will help people with type 1 diabetes improve their blood glucose levels.

Inclusion Criteria: