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Diabetes Mellitus, Type 1ACT1ON DP3NCT03651622

ACT1ON Phase 2 (SMART Pilot) and Phase 3 (Efficacy Trial Development)

A study testing Hypocaloric, low carbohydrate diet, Hypocaloric, moderate low fat diet and Mediterranean diet, no caloric restriction in people with Diabetes Mellitus, Type 1 and Overweight and Obesity, run by University of North Carolina, Chapel Hill at 2 sites 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

An initial pilot and feasibility study will be conducted using a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management in young adults with Type 1 diabetes (T1D). Read more about this study

Who is it for?
Ages 19 to 30 years
What is being tested?
Hypocaloric, low carbohydrate diet, Hypocaloric, moderate low fat diet and Mediterranean diet, no caloric restriction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
2 sitesUnited States
Study dates
12 Nov 2018to 31 Mar 2021
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 19 to 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Individuals 19-30 years old at enrollment
  • History of Type 1 diabetes for greater than one year
  • Latest hemoglobin A1c less than 13%
  • BMI of 27-39

Who cannot join

  • Individuals with other metabolic disorders, unstable thyroid disease, diagnosed eating disorder, prohibitive strict dietary restrictions or those with other serious condition that renders participation inappropriate
  • Individuals who have experience diabetic ketoacidosis (DKA) or severe hypoglycemia requiring outside assistance in the last 6 months
  • Females who are pregnant, breastfeeding, have delivered a baby in the last 12 months, or are planning to become pregnant during the study period.
  • Individuals unwilling to follow any of the three study diets
  • Individuals who monitor blood glucose less than 3 times a day

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Stanford University

    Palo Alto, California, 94304

Other trials in United States

About this study

Official title: Accelerating Solutions to Optimize Glycemic Control and Weight Management In Young Adults With Type 1 Diabetes

An initial pilot and feasibility study will be conducted using a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management in young adults with Type 1 diabetes (T1D). This pilot trial will include a ten-and-a-half month behavioral intervention, with co-primary outcomes of glycemic control (HbA1C and hypoglycemia) and weight loss. The pilot trial will assess acceptability and adherence to three distinct, evidence-based dietary approaches designed to address weight management and glycemic control. Behavioral counseling strategies, use of carbohydrate counting for insulin dosing, and encouragement of physical activity will be the same across the three dietary approaches.

COVID-19 PROVISIONS: Due to restrictions in place on in-person visits due to COVID-19 precautions, some subjects may remain in the study longer than 10.5 months. As of June 2020, the study transitioned to a completely virtual format. Those who were due for a measurement visit during the time that research activities were halted, prior to the approval of the virtual procedures, remained on the diet they were currently assigned to, supported by bi-weekly Registered Dietitian (RD) counseling, until they were able to be scheduled for a virtual visit.

Read the detailed description

Eight-four participants will be randomized in total; 42 at the University of North Carolina (UNC), 42 at Stanford.

COVID-19 Provisions: Due to impacts of COVID-19, the study was forced to cease recruitment early. 40 subjects were randomized at UNC and 29 were randomized at Stanford, for a total of 69 subjects across sites.

Procedures (methods):

Three distinct dietary approaches will be tested. Dietary approaches are as follows:

Diet 1: hypocaloric, moderate low fat (30% calories from fat) weight management based on the Look AHEAD study Diet 2: hypocaloric, low carbohydrate (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat) Diet 3: advice to select a healthy Mediterranean dietary pattern with no caloric restriction

Participants will complete measurement visits at baseline (-14 days), 3 mos, 6.5 mos, and 10 mos. All visits transitioned to a virtual format as of 6/2020 due to COVID-19 provisions.

Participants will complete a total of 23 intervention sessions over an approximately 10-and-a-half month period (Eight longer sessions (teleconference) and 15 telephone check-ins)

Participants will be randomized to one of the three diets for a minimum of a three-and-a-half month period. Re-randomization is possible following the 3 month and/or 6.5 month measurement visits. Re-randomization is based on acceptability of diet (self-report), non-severe hypoglycemic events (self-report), and not achieving significant weight change (defined as losing at least 2% of body weight from previous study visit), and worsening glycemic control (increase in Hemoglobin A1c of >/= 0.5% from previous study visit). Re-randomization will occur after the 14-day continuous glucose monitoring (CGM) wear period that will be initiated at each measurement visit.

Being tested
Hypocaloric, low carbohydrate diet, Hypocaloric, moderate low fat diet, Mediterranean diet, no caloric restriction
Keywords
Type 1 diabetes, T1D, Type 1 diabetes mellitus (T1DM), weight management, overweight, obese
Medical subject headings
Diabetes Mellitus, Type 1, Overweight, Obesity

What participants receive

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

  • Hypocaloric, low carbohydrate dietBehavioural

    Also called Low carbohydrate diet

    Participants will be advised on use of a hypocaloric, low carbohydrate diet using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.

  • Hypocaloric, moderate low fat dietBehavioural

    Also called Low fat diet

    Participants will be advised on use of a hypocaloric, moderate low fat diet using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.

  • Mediterranean diet, no caloric restrictionBehavioural

    Also called Mediterranean diet

    Participants will be advised on use of a healthy Mediterranean-based eating plan using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.

Study groups in NCT03651622
Study groupRoleWhat they receive
Hypocaloric, low carbohydrateExperimentalBehavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Receives: Behavioral: Hypocaloric, low carbohydrate diet
Hypocaloric, moderate low fatExperimentalBehavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Receives: Behavioral: Hypocaloric, moderate low fat diet
Mediterranean, no caloric restrictionExperimentalBehavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Receives: Behavioral: Mediterranean diet, no caloric restriction

What is being measured

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

  1. Change in Weight - Randomization 1

    Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

    Measured: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit

  2. Change in Weight - Randomization 2

    Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

    Measured: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit

  3. Change in Weight - Randomization 3

    Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

    Measured: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit

  4. Change in HbA1C - Randomization 1

    HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

    Measured: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit

  5. Change in HbA1C - Randomization 2

    HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

    Measured: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit

  6. Change in HbA1C - Randomization 3

    HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

    Measured: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit

  7. Change in Time in Clinical Hypoglycemia - Randomization 1

    Change in the percent of time spent in clinical hypoglycemia (54-69 mg/dl) during Continuous Glucose Monitor (CGM) wear time will be assessed between the two weeks of wear from CGM insertion at Baseline Visit (-14 days) and the two weeks of wear from the insertion of the CGM at Measurement Visit 2.

    Measured: 2 weeks of wear from Baseline Visit (-14 Days), 2 weeks of wear from 3 Month (Measurement 2) Visit

  8. Change in Time in Clinical Hypoglycemia - Randomization 2

    Change in the percent of time spent in clinical hypoglycemia (54-69 mg/dl) during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 2 Visit and from CGM insertion at Measurement 3 Visit.

    Measured: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit

  9. Change in Time in Clinical Hypoglycemia - Randomization 3

    Change in the percent of time spent in clinical hypoglycemia (54-69 mg/dl) during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 3 Visit and from CGM insertion at Measurement 4 Visit.

    Measured: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit

Secondary outcomes (6)

  1. Change in Body Fat - Randomization 1

    Percent fat mass and percent fat free mass were measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this time three-and-a-half-month time period.

    COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data continued, but no new DXA data were collected.

    Measured: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit

  2. Change in Body Fat - Randomization 2

    Percent fat mass and percent fat free mass were measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this time three-and-a-half-month time period.

    COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data continued, but no new DXA data were collected.

    Measured: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit

  3. Change in Body Fat - Randomization 3

    Percent fat mass and percent fat free mass were measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this time three-and-a-half-month time period.

    COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data continued, but no new DXA data were collected.

    Measured: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit

  4. Change in Time in Target Glucose Range - Randomization 1

    Change in percent of time spent in a pre-defined range of relative euglycemia (70-180 mg/dl, for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Baseline Visit (-14 days) and the two weeks of wear from CGM insertion at Measurement Visit 2.

    Measured: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit

  5. Change in Time in Target Glucose Range - Randomization 2

    Change in percent of time spent in a pre-defined range of relative euglycemia (70-180 mg/dl, for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Measurement 2 Visit and from CGM insertion at Measurement 3 Visit.

    Measured: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit

  6. Change in Time in Target Glucose Range - Randomization 3

    Change in percent of time spent in a pre-defined range of relative euglycemia (70-180 mg/dl, for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Measurement 3 Visit and from CGM insertion at Measurement 4 Visit.

    Measured: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit

Timeline

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

  1. First posted29 Aug 2018
  2. Study start12 Nov 2018
  3. Primary completion31 Mar 2021
  4. Study completion31 Mar 2021

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
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
This initial pilot and feasibility study uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management. The study will be done at UNC and Stanford. Sequential randomization will occur at 0, 3.5, and 7 months. Following the baseline measurement visit and two week run-in period, participants will be randomized to one of three diets (stratified by site with block size of 4). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the assigned diet is not acceptable or effective will be re-randomized (or re-assigned if only one diet remains untried). 10.5 months of follow-up time allows for evaluation of the effect of diets on initial weight loss and on early maintenance of initial weight loss. Decision criteria for re-randomization will incorporate clinical outcomes (glycemic control and weight change) and acceptability of the diet.
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03651622
Sponsor's protocol ID
18-1025
Other IDs
1DP3DK113358-01
Acronym
ACT1ON DP3
Status last verified
Apr 2021
First submitted
27 Aug 2018
Last updated
4 Mar 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Igudesman D, Crandell J, Corbin KD, Muntis F, Zaharieva DP, Casu A, Thomas JM, Bulik CM, Carroll IM, Pence BW, Pratley RE, Kosorok MR, Maahs DM, Mayer-Davis EJ. The Intestinal Microbiota and Short-Chain Fatty Acids in Association with Advanced Metrics of Glycemia and Adiposity Among Young Adults with Type 1 Diabetes and Overweight or Obesity. Curr Dev Nutr. 2022 Oct 30;6(10):nzac107. doi: 10.1093/cdn/nzac107. eCollection 2022 Nov.

    PubMed 36349343

  • Muntis FR, Igudesman D, Sarteau AC, Thomas J, Arrizon-Ruiz N, Hooper J, Addala A, Crandell JL, Riddell MC, Maahs DM, Pratley RE, Corbin K, Mayer-Davis EJ, Zaharieva DP; ACT1ON Consortium. Relationship Between Moderate-to-Vigorous Physical Activity and Glycemia Among Young Adults with Type 1 Diabetes and Overweight or Obesity: Results from the Advancing Care for Type 1 Diabetes and Obesity Network (ACT1ON) Study. Diabetes Technol Ther. 2022 Dec;24(12):881-891. doi: 10.1089/dia.2022.0253.

    PubMed 35984327

  • Corbin KD, Igudesman D, Addala A, Casu A, Crandell J, Kosorok MR, Maahs DM, Pokaprakarn T, Pratley RE, Souris KJ, Thomas JM, Zaharieva DP, Mayer-Davis EJ; ACT1ON Consortium. Design of the Advancing Care for Type 1 Diabetes and Obesity Network energy metabolism and sequential multiple assignment randomized trial nutrition pilot studies: An integrated approach to develop weight management solutions for individuals with type 1 diabetes. Contemp Clin Trials. 2022 Jun;117:106765. doi: 10.1016/j.cct.2022.106765. Epub 2022 Apr 20.

    PubMed 35460915

Questions about this trial

What is this clinical trial studying?

A study testing Hypocaloric, low carbohydrate diet, Hypocaloric, moderate low fat diet and Mediterranean diet, no caloric restriction in people with Diabetes Mellitus, Type 1 and Overweight and Obesity, run by University of North Carolina, Chapel Hill at 2 sites 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 4 inclusion and 5 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 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 4 Mar 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?

Change in Weight - Randomization 1 (time frame: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit). The study lists 9 primary outcomes in all. 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 NCT03651622, which also lists 3 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 4 Mar 2022.

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